Trial Outcomes & Findings for Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer (NCT NCT01053013)

Last Updated: 2021-05-12

Results Overview

The primary efficacy outcome is post-implantation all-cause mortality, where time to death is defined as the time from the most recent scan prior to first implantation (time of origin, To) to death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

From date of the most recent scan (disease progression) prior to the first macrobead implantation; assessed up to 32 months.

Results posted on

2021-05-12

Participant Flow

Participants were recruited based on physician referral between April 2010 and February 2016. The first participant was implanted on April 15, 2010 (pancreatic) and May 14, 2010 (mCRC). The last implantation was on March 4, 2016 (pancreatic) and October 18, 2013 (mCRC).

90 participants provided informed consent to participate in the study (Pancreatic cancer n=34; mCRC n=46). Of these, 24 pancreatic cancer patients and 34 mCRC patients were enrolled in the study. The 22 patients who were not enrolled into the study, after providing consent, had failed the respective eligibility criteria (n=19) or decided not to enroll in the study (n=3).

Participant milestones

Participant milestones
Measure	Pancreatic Cancer Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads
Overall Study STARTED	24	34
Overall Study COMPLETED	24	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pancreatic Cancer n=24 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=34 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Total n=58 Participants Total of all reporting groups
Age, Continuous	60.25 years STANDARD_DEVIATION 12.37 • n=5 Participants	58.00 years STANDARD_DEVIATION 10.11 • n=7 Participants	58.93 years STANDARD_DEVIATION 11.05 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	23 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized White	22 Participants n=5 Participants	27 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of the most recent scan (disease progression) prior to the first macrobead implantation; assessed up to 32 months.

Population: Participants who received at least one RENCA macrobead implant.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=24 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=34 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 CRP levels at day 14 after second implantation.	Implant 2: Day 30 CRP levels at day 30 after second implantation.	Implant 2: Day 60 CRP levels at day 60 after second implantation.
Overall Survival - Based on Most Recent Scan	4.66 months Interval 2.43 to 5.74	7.7 months Interval 6.1 to 12.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of the first RENCA macrobead implant; assessed up to 32 months.

Population: Participants who received at least one RENCA macrobead implant.

The secondary efficacy objective was to evaluate overall survival calculated using the time from first RENCA macrobead implantation to death from any cause.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=24 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=34 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 CRP levels at day 14 after second implantation.	Implant 2: Day 30 CRP levels at day 30 after second implantation.	Implant 2: Day 60 CRP levels at day 60 after second implantation.
Overall Survival - Based on 1st Implant	4.3 months Interval 2.03 to 5.18	7.3 months Interval 5.4 to 11.4	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From date of Stage IV disease diagnosis up to 126 months; up to 32 months from first RENCA macrobead implant.

Population: Participants who received at least one RENCA macrobead implant.

The secondary efficacy objective was to evaluate overall survival calculated using the time from Stage IV disease diagnosis to death from any cause.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=24 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=34 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 CRP levels at day 14 after second implantation.	Implant 2: Day 30 CRP levels at day 30 after second implantation.	Implant 2: Day 60 CRP levels at day 60 after second implantation.
Overall Survival - Based on Stage IV Disease Diagnosis	15.7 months Interval 11.97 to 18.89	32.1 months Interval 27.2 to 43.2	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline vs. Day 90 post-Implant 1

Population: mCRC participants who had received at least one macrobead implant and for whom baseline PET-CT scan and day 90 post-Implant 1 PET-CT scan data were available. n=26 subjects; 77 lesions evaluated. No formal analysis was performed on the pancreatic cancer cohort as a meaningful analysis was limited based on the small group size with baseline and day 90 scans.

Tumors were assessed by positron emission tomography (PET)-CT scan at baseline and day 90 following the first RENCA macrobead implantation. The use of \[13\]F-fluorodeoxyglucose (FDG) uptake for the detection of lesions \>1 cm in diameter allowed evaluation of metabolic activity. Decreases in FDG uptake were indicative of metabolic suppression of the tumor. The use of PET-CT scanning indicated anatomical localization, approximate size/volume of primary tumor and metastatic lesion(s), and assessment of metabolic activity of the tumor (as an indicator of metabolic health and necrosis). Disease state is reported as a function of Tumor measurement divided by SUVmax. Changes were assessed between day 90 post RENCA macrobead implant and baseline values. Patients with no change = stable; patients with decreased values = decreased/necrosis, and patients with increased values = increased.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=87 lesions Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=87 lesions Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=87 lesions mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 CRP levels at day 14 after second implantation.	Implant 2: Day 30 CRP levels at day 30 after second implantation.	Implant 2: Day 60 CRP levels at day 60 after second implantation.
Necrosis Comparison of Tumors Using PET-CT Scan	15 lesions	42 lesions	30 lesions	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline up to and including day 30 post-Implant 1

Population: Participants with mCRC receiving at least one RENCA macrobead implantation.

Tumor markers included serum carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9), and were assessed on all participants with mCRC at baseline and at subsequent evaluation points to further assess tumor response to RENCA macrobead implantation. A tumor marker response was defined as a greater than or equal to 20% decrease in one or both of CEA or CA 19-9.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=34 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=34 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=34 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=34 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 CRP levels at day 14 after second implantation.	Implant 2: Day 30 CRP levels at day 30 after second implantation.	Implant 2: Day 60 CRP levels at day 60 after second implantation.
Tumor Marker Response of mCRC Participants	7 Participants	3 Participants	15 Participants	9 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from baseline up to and including day 30 post-Implant 1.

Population: Participants with pancreatic cancer receiving at least one RENCA macrobead implantation.

Tumor markers included serum carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9), and were assessed on all participants with pancreatic cancer at baseline and at subsequent evaluation points to further assess tumor response to RENCA macrobead implantation. A tumor marker response was defined as a greater than or equal to 20% decrease in one or both of CEA or CA 19-9.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=24 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=24 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=24 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=24 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 CRP levels at day 14 after second implantation.	Implant 2: Day 30 CRP levels at day 30 after second implantation.	Implant 2: Day 60 CRP levels at day 60 after second implantation.
Tumor Marker Response of Pancreatic Cancer Participants	3 Participants	1 Participants	6 Participants	14 Participants	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

Population: Implant 1 (Days 0-60): Participants with mCRC who had received at least 1 RENCA macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Participants with mCRC who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.

C-reactive protein (CRP) is one of three inflammatory markers assessed during this study. CRP levels were assessed as a marker of systemic inflammatory processes.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=33 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=34 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=34 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=30 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=13 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=12 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=13 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 n=11 Participants CRP levels at day 60 after second implantation.
C-reactive Protein Levels in mCRC Participants	3.1 mg/dL Standard Deviation 4.2	19.3 mg/dL Standard Deviation 8.1	8.9 mg/dL Standard Deviation 5.9	6.7 mg/dL Standard Deviation 6.9	10.2 mg/dL Standard Deviation 23.6	23.5 mg/dL Standard Deviation 50.8	11.4 mg/dL Standard Deviation 8.3	5.5 mg/dL Standard Deviation 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

Population: Implant 1 (Days 0-60): Pancreatic cancer participants who had received at least 1 implant and were screened as indicated; Implant 2 (Days 0-60): Pancreatic cancer participants who had received at least 2 RENCA macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.

C-reactive protein (CRP) is one of three inflammatory markers assessed during this study. CRP levels were assessed as a marker of systemic inflammatory processes.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=24 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=21 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=20 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=15 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=3 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=3 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=3 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 n=1 Participants CRP levels at day 60 after second implantation.
C-Reactive Protein Levels in Pancreatic Cancer Participants	1.7 mg/dL Standard Deviation 2.0	30.7 mg/dL Standard Deviation 46.7	13.8 mg/dL Standard Deviation 22.9	6.7 mg/dL Standard Deviation 11.6	1.4 mg/dL Standard Deviation 1.3	3.1 mg/dL Standard Deviation 1.7	89.8 mg/dL Standard Deviation 148.4	7.52 mg/dL

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

Erythrocyte sedimentation rate (ESR) is one of three inflammatory markers assessed during this study. ESR was assessed as a marker of systemic inflammatory processes.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=33 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=34 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=32 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=30 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=13 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=10 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=12 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 n=10 Participants CRP levels at day 60 after second implantation.
Erythrocyte Sedimentation Rate in mCRC Participants	44.9 mm/hr Standard Deviation 30.9	92.7 mm/hr Standard Deviation 31.4	85.8 mm/hr Standard Deviation 37.3	68.1 mm/hr Standard Deviation 39.6	53.5 mm/hr Standard Deviation 16.1	93.3 mm/hr Standard Deviation 27.7	92.7 mm/hr Standard Deviation 23.1	74.9 mm/hr Standard Deviation 28.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

Erythrocyte sedimentation rate (ESR) is one of three inflammatory markers assessed during this study. ESR was assessed as a marker of systemic inflammatory processes.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=23 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=18 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=18 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=11 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=3 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=2 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=1 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 CRP levels at day 60 after second implantation.
Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants	33 mm/hr Standard Deviation 24.6	51.9 mm/hr Standard Deviation 31.3	49.2 mm/hr Standard Deviation 12.9	78.6 mm/hr Standard Deviation 13.8	83.3 mm/hr Standard Deviation 5.8	90.0 mm/hr Standard Deviation 14.1	80.0 mm/hr	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

Cancer Antigen 125 (CA 125) is one of three inflammatory markers assessed during this study. CA 125 was used to monitor more localized intra-abdominal/peritoneal inflammatory processes related to the placement of the RENCA macrobeads or, in some cases, the intraperitoneal spread of tumor.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=33 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=33 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=34 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=30 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=13 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=12 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=13 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 n=11 Participants CRP levels at day 60 after second implantation.
Cancer Antigen 125 Levels in mCRC Participants	43.5 U/mL Standard Deviation 76.65	95.5 U/mL Standard Deviation 73.5	83.7 U/mL Standard Deviation 86.6	67.6 U/mL Standard Deviation 106.1	39.2 U/mL Standard Deviation 49.1	63.7 U/mL Standard Deviation 29.1	48.7 U/mL Standard Deviation 31.4	38.0 U/mL Standard Deviation 31.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=23 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=21 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=20 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=15 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=3 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=2 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=2 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 n=1 Participants CRP levels at day 60 after second implantation.
Cancer Antigen 125 Levels in Pancreatic Cancer Participants	147.9 U/mL Standard Deviation 278.6	300.7 U/mL Standard Deviation 410.6	409.4 U/mL Standard Deviation 607.0	291.7 U/mL Standard Deviation 289.2	49.7 U/mL Standard Deviation 30.1	88.5 U/mL Standard Deviation 7.8	117.0 U/mL Standard Deviation 46.7	57.0 U/mL

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2

Population: Implant (day 0 to day 60): Participants with mCRC who received at least one RENCA macrobead implantation; Implant 2 (day 0 to day 60): Participants who received at least two RENCA macrobead implantations.

The Eastern Cooperative Oncology Group (ECOG) performance scale is a 5-point scale, where 0 denotes perfect health and 5 is death. It is used by clinicians to assess disease progression and how the disease is affecting the daily living abilities of the patient. The ECOG Performance Status scores are defined as follows: 0: Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physical strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light house work, office work). 2. Ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours. 3. Capable of only limited self-care, confined to bed or chair 50% or more of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Death

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=28 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=25 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=24 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=24 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=12 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=6 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=9 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 n=9 Participants CRP levels at day 60 after second implantation.
Performance Status (ECOG Score) of mCRC Participants ECOG Score 1	15 Participants	15 Participants	16 Participants	10 Participants	5 Participants	3 Participants	4 Participants	5 Participants
Performance Status (ECOG Score) of mCRC Participants ECOG Score 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Performance Status (ECOG Score) of mCRC Participants ECOG Score 0	13 Participants	4 Participants	3 Participants	4 Participants	5 Participants	0 Participants	2 Participants	1 Participants
Performance Status (ECOG Score) of mCRC Participants ECOG Score 2	0 Participants	5 Participants	3 Participants	6 Participants	2 Participants	3 Participants	3 Participants	2 Participants
Performance Status (ECOG Score) of mCRC Participants ECOG Score 3	0 Participants	1 Participants	2 Participants	4 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Performance Status (ECOG Score) of mCRC Participants ECOG Score 5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2

Population: Implant 1 (Days 0-60): Pancreatic cancer participants who had received at least 1 macrobead implantation and were screened as indicated; Implant 2 (Days 0-60): Pancreatic cancer participants who had received at least 2 macrobead implantations and were screened as indicated. In some cases, participants may not have had all assessments conducted as scheduled. In those incidents, the number of participants analyzed has been adjusted to include only those participants for which data was available.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=23 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=20 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=16 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=12 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=3 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=2 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=2 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 CRP levels at day 60 after second implantation.
Performance Status (ECOG Score) of Pancreatic Cancer Participants ECOG Score 3	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—
Performance Status (ECOG Score) of Pancreatic Cancer Participants ECOG Score 5	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Performance Status (ECOG Score) of Pancreatic Cancer Participants ECOG Score 0	11 Participants	1 Participants	3 Participants	4 Participants	1 Participants	1 Participants	0 Participants	—
Performance Status (ECOG Score) of Pancreatic Cancer Participants ECOG Score 1	7 Participants	11 Participants	8 Participants	4 Participants	1 Participants	1 Participants	2 Participants	—
Performance Status (ECOG Score) of Pancreatic Cancer Participants ECOG Score 2	5 Participants	7 Participants	5 Participants	2 Participants	1 Participants	0 Participants	0 Participants	—
Performance Status (ECOG Score) of Pancreatic Cancer Participants ECOG Score 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Day 14, 30, 60 Post-Implant 1; Day 14, 30, 60 post-Implant 2

Karnofsky Performance Status (KPS) is a self-rated scale that measures the participant's ability to perform daily functions, ranging from 0 ("dead") to 100 ("normal, no complaints, no evidence of disease). Karnofsky scores are defined as follows: 100: Normal; no complaints; no evidence of disease 90: Able to carry on normal activity with effort, minor sign or symptoms of disease 80: Normal activity with effort; some sign or symptoms of disease 70: Cares for self; unable to carry on normal activity or do active work 60: Requires occasional assistance, but is able to care for most personal needs 50: Requires considerable assistance and frequent medical care 40: Disabled; requires special care and assistance 30: Severely disabled; hospitalization is indicated, although death is not imminent 20: Very sick; hospitalization/active support treatment is necessary 10: Moribund; fatal processes progressively worsening 0: Dead

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=32 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=26 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=27 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=28 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=13 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=8 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=11 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 n=10 Participants CRP levels at day 60 after second implantation.
Activities of Daily Living (KPS Score) of mCRC Participants	90.0 score on a scale Standard Deviation 7.2	81.2 score on a scale Standard Deviation 11.8	80.4 score on a scale Standard Deviation 11.6	74.1 score on a scale Standard Deviation 16.6	84.2 score on a scale Standard Deviation 9.1	76.3 score on a scale Standard Deviation 11.9	82.7 score on a scale Standard Deviation 9.1	76.0 score on a scale Standard Deviation 16.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=24 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=19 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=14 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=11 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=3 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=2 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=1 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 CRP levels at day 60 after second implantation.
Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants	87.9 score on a scale Standard Deviation 9.3	79.5 score on a scale Standard Deviation 9.7	78.6 score on a scale Standard Deviation 12.9	78.6 score on a scale Standard Deviation 13.8	83.3 score on a scale Standard Deviation 5.8	90.0 score on a scale Standard Deviation 14.1	80.0 score on a scale	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2

The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales, three symptom scales, a global health status score, and six single items. The Global Health Status is assessed from 2 of the 30 questions (Question 29 and 30), whose response score ranges on a 7 point scale. The score for physical function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor) and the maximum value is 100 (best outcome, excellent). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

Outcome measures

Outcome measures
Measure	Pancreatic Cancer n=32 Participants Pancreatic cancer patients will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA Macrobeads.	Metastatic Colorectal Cancer n=25 Participants Metastatic colorectal cancer (mCRC) patients who will undergo up to 4 implantations of RENCA macrobeads (no less than 3 months apart), at a dosage level of 8 RENCA macrobeads per kilogram of body weight. RENCA macrobeads	Increased n=26 Participants mCRC participants with increased SUVmax, tumor measurement based on imaging results.	mCRC: Non-responder n=26 Participants Participants with mCRC whose tumor marker response (serum level of CEA and/or CA 19-9) did not decrease by greater than or equal to 20% of baseline value.	Implant 2: Day 0 n=13 Participants CRP levels at day 0 of second implantation (day 90 following first implantation).	Implant 2: Day 14 n=7 Participants CRP levels at day 14 after second implantation.	Implant 2: Day 30 n=10 Participants CRP levels at day 30 after second implantation.	Implant 2: Day 60 n=9 Participants CRP levels at day 60 after second implantation.
Global Health Status of mCRC Participants	94.0 score on a scale Standard Deviation 8.4	78.8 score on a scale Standard Deviation 15.9	80.6 score on a scale Standard Deviation 17.3	75.1 score on a scale Standard Deviation 25.9	86.0 score on a scale Standard Deviation 11.4	78.6 score on a scale Standard Deviation 9.6	86.7 score on a scale Standard Deviation 9.5	83.3 score on a scale Standard Deviation 16.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2