Trial Outcomes & Findings for Combination Chemoembolization and Stereotactic Body Radiation Therapy in Unresectable Hepatocellular Carcinoma (NCT NCT02513199)

Last Updated: 2023-06-18

Results Overview

Tumor response will be assessed using mRECIST criteria as well diffusion weight imaging (DWI) via Magnetic Resonance Imaging (MRI) surveillance. * Complete response (CR): Disappearance of all target lesions * Partial response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD * Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started * Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

up to 72 months

Results posted on

2023-06-18

Participant Flow

Between 2014 and 2020, of 33 potential candidates screened at the Liver Cancer Program at Mount Sinai Hospital in New York, NY, 32 patients were finally enrolled in the study.

Participant milestones

Participant milestones
Measure	TACE/SBRT Combination Participants with HCC with a lesion greater than 3 cm treated with TACE/SBRT combination. SBRT: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days. TACE: two sessions of standard TACE with ethiodol separated by a 4-week interval.
Treatment STARTED	32
Treatment COMPLETED	30
Treatment NOT COMPLETED	2
Follow-Up STARTED	30
Follow-Up COMPLETED	19
Follow-Up NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	TACE/SBRT Combination Participants with HCC with a lesion greater than 3 cm treated with TACE/SBRT combination. SBRT: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days. TACE: two sessions of standard TACE with ethiodol separated by a 4-week interval.
Treatment Death	1
Treatment Lost to Follow-up	1
Follow-Up Death	11

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TACE/SBRT Combination n=32 Participants Participants with HCC with a lesion greater than 3 cm treated with TACE/SBRT combination. SBRT: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days. TACE: two sessions of standard TACE with ethiodol separated by a 4-week interval.
Age, Continuous	67.5 years n=32 Participants
Sex: Female, Male Female	10 Participants n=32 Participants
Sex: Female, Male Male	22 Participants n=32 Participants
Number of participants with HCV Etiology	21 Participants n=32 Participants
Number of Participants with HBV Etiology	3 Participants n=32 Participants
Number of Participants with NASH Etiology	3 Participants n=32 Participants
Number of Participants with Alcohol Etiology for HCC	4 Participants n=32 Participants
Child-Turcotte-Pugh (CTP) Score A5	18 Participants n=32 Participants
Child-Turcotte-Pugh (CTP) Score A6	10 Participants n=32 Participants
Child-Turcotte-Pugh (CTP) Score B7 or greater	2 Participants n=32 Participants
Albumin-Bilirubin (ALBI) Grade Grade 1	15 Participants n=32 Participants
Albumin-Bilirubin (ALBI) Grade Grade 2	16 Participants n=32 Participants
Albumin-Bilirubin (ALBI) Grade Grade 3	1 Participants n=32 Participants
ALBI Score	-2.45 ALBI score n=32 Participants
Platelet Count	150 10^3 cells/uL n=32 Participants
Tumor Size	4.6 cm n=32 Participants
Number of Participants with Tumor Size ≥5	12 Participants n=32 Participants
Alpha-fetoprotein (AFP)	7.9 ng/mL n=32 Participants
Number of Participants with AFP ≥400ng/mL	5 Participants n=32 Participants
Tumor Dose	45 Gy n=32 Participants
Biologic Effective Dose	86 Gy n=32 Participants

PRIMARY outcome

Timeframe: up to 72 months

Outcome measures

Outcome measures
Measure	TACE/SBRT Combination n=30 Participants SBRT: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days. TACE: two sessions of standard TACE with ethiodol separated by a 4-week interval.
Number of Participants With Objective Response Rate Complete response (CR)	20 Participants
Number of Participants With Objective Response Rate Partial response (PR)	9 Participants
Number of Participants With Objective Response Rate Stable disease (SD)	0 Participants
Number of Participants With Objective Response Rate Progressive disease (PD)	1 Participants

SECONDARY outcome

Timeframe: up to 72 months

Time to Complete Remission (CR)

Outcome measures

Outcome measures
Measure	TACE/SBRT Combination n=30 Participants SBRT: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days. TACE: two sessions of standard TACE with ethiodol separated by a 4-week interval.
Time to CR	10.1 months Interval 1.0 to 72.0

SECONDARY outcome

Timeframe: up to 80 months

The time to progression of the treated lesion. Median TTP, as defined as progression events (not including death), was not reached because 50% of events were not achieved. Because a sufficient number of progression events did not happen at the time of study censure, a median could not be reported. Therefore, mean is reported which can be reported irrespective of events.

Outcome measures

Outcome measures
Measure	TACE/SBRT Combination n=30 Participants SBRT: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days. TACE: two sessions of standard TACE with ethiodol separated by a 4-week interval.
Time to Progression (TTP)	76.60 months Standard Deviation 23.40

SECONDARY outcome

Timeframe: 2 years

The overall survival as defined from completion of treatment until death

Outcome measures

Outcome measures
Measure	TACE/SBRT Combination n=32 Participants SBRT: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days. TACE: two sessions of standard TACE with ethiodol separated by a 4-week interval.
Number of Participants With Overall Survival (OS)	20 Participants

SECONDARY outcome

Timeframe: up to 72 months

Population: under efficacy, median PFS 35 months. under conclusions, PFS median 2.9 years (34.8months) and later on says PFS was 13.9 months

Progression-free survival (PFS), defined as time between enrollment and tumor progression assessed by mRECIST or death, local control (LC), and toxic effects. LC was defined as either absence of radiographic progression or a secondary intervention (ie, surgery or TACE) made to the index lesion due to a perceived incomplete treatment response.

Outcome measures

Outcome measures
Measure	TACE/SBRT Combination n=30 Participants SBRT: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days. TACE: two sessions of standard TACE with ethiodol separated by a 4-week interval.
Progression Free Survival (PFS)	35 months Interval 15.0 to 72.0

SECONDARY outcome

Timeframe: 3 months

Population: one participant did not have pre and post-CTP scores.

Overall rate of toxic effects as measured by change in Child-Turcotte-Pugh (CTP) score at 3 months as compared to baseline. The Child-Turcotte-Pugh (CTP) is a scale that assesses a patients baseline liver function and can help predict morbidity and mortality based on that score. Class A - 5 to 6 points, least severe liver disease, one- to five-year survival rate: 95 percent Class B - 7 to 9 points, moderately severe liver disease, one- to five-year survival rate: 75 percent Class C - 10 to 15 points, most severe liver disease, one- to five-year survival rate: 50 percent Higher scores correlate with more general mortality.

Outcome measures

Outcome measures
Measure	TACE/SBRT Combination n=29 Participants SBRT: Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days. TACE: two sessions of standard TACE with ethiodol separated by a 4-week interval.
Change in Child-Turcotte-Pugh (CTP) Score Increase	3 Participants
Change in Child-Turcotte-Pugh (CTP) Score Decrease	3 Participants
Change in Child-Turcotte-Pugh (CTP) Score No Change	22 Participants
Change in Child-Turcotte-Pugh (CTP) Score Decompensated	1 Participants

Adverse Events

TACE/SBRT Combination

Serious events: 0 serious events

Other events: 0 other events

Deaths: 12 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Buckstein

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7502

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place