Trial Outcomes & Findings for Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma (NCT NCT04097028)

Last Updated: 2025-04-29

Results Overview

Will be determined by pathologic examination of resected specimen: complete response to induction chemotherapy followed by standard chemoradiation and surgery. Will be summarized using frequencies and relative frequencies. Will be estimated using an 80% confidence interval obtained using Jeffrey's prior method. Response is assessed by the tumor regression score (as proposed by NCCN guidelines): Complete Response: No viable cancer cells, including lymph nodes Near Complete Response: Single cells or rare small groups of cancer cells Partial Response: Residual cancer with evident tumor regression but more than single cells or rare small groups of cancer cells Poor or No Response: Extensive residual disease with no evident tumor regression

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

Assessed at the time of surgery (approximately 6 months after start of neoadjuvant therapy)

Results posted on

2025-04-29

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (TAS-102, Oxaliplatin) Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. Trifluridine and Tipiracil Hydrochloride: Given PO Oxaliplatin: Given IV
Overall Study STARTED	22
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (TAS-102, Oxaliplatin) Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. Trifluridine and Tipiracil Hydrochloride: Given PO Oxaliplatin: Given IV
Overall Study Disease Progression Prior to completion of Chemoradiation	2
Overall Study Adverse Event prior to Completion of Chemoradiation	2
Overall Study Disease Progression prior to Surgery	2
Overall Study Adverse Event prior to Surgery	1

Baseline Characteristics

Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (TAS-102, Oxaliplatin) n=22 Participants Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. Trifluridine and Tipiracil Hydrochloride: Given PO Oxaliplatin: Given IV
Age, Continuous	58.7 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at the time of surgery (approximately 6 months after start of neoadjuvant therapy)

Population: Only 15 patients completed surgery.

Outcome measures

Outcome measures
Measure	Treatment (TAS-102, Oxaliplatin) n=15 Participants Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. Trifluridine and Tipiracil Hydrochloride: Given PO Oxaliplatin: Given IV
Number of Patients With a Pathologic Complete Response	2 Participants

SECONDARY outcome

Timeframe: Time from treatment until disease progression, death from disease, or last follow-up, assessed up to 2 years

Will be summarized using standard Kaplan-Meier methods; where estimates of median survival and two-year survival rates will be obtained with 95% confidence intervals. Progression is assessed by RECIST v1.0, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Treatment (TAS-102, Oxaliplatin) n=22 Participants Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. Trifluridine and Tipiracil Hydrochloride: Given PO Oxaliplatin: Given IV
Median Progression Free Survival	20.3 months Interval 5.9 to Due to the sample size and number of events the upper limit of the confidence interval is not estimable (or NE). This is very common in survival data and should not require additional explanation.

SECONDARY outcome

Timeframe: Time from treatment until death due to any cause or last follow-up, assessed up to 2 years

Will be summarized using standard Kaplan-Meier methods; where estimates of median survival and two-year survival rates will be obtained with 95% confidence intervals

Outcome measures

Outcome measures
Measure	Treatment (TAS-102, Oxaliplatin) n=22 Participants Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. Trifluridine and Tipiracil Hydrochloride: Given PO Oxaliplatin: Given IV
Median Overall Survival	20.3 months Interval 8.6 to Due to the sample size and number of events, the upper limit of the confidence interval is not estimable.

SECONDARY outcome

Timeframe: Up to 30 days after last dose of study drug, which is a maximum of 210 days.

Toxicities and adverse events (as per Common Terminology Criteria for Adverse Events version 5.0) will be summarized by attribution and grade using frequencies and relative frequencies.

Outcome measures

Outcome measures
Measure	Treatment (TAS-102, Oxaliplatin) n=22 Participants Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. Trifluridine and Tipiracil Hydrochloride: Given PO Oxaliplatin: Given IV
Number of Patients With Grade 3 or Higher Treatment Related Adverse Events	5 Participants

Adverse Events

Treatment (TAS-102, Oxaliplatin)

Serious events: 3 serious events

Other events: 17 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (TAS-102, Oxaliplatin) n=22 participants at risk Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. Trifluridine and Tipiracil Hydrochloride: Given PO Oxaliplatin: Given IV
Gastrointestinal disorders Colonic perforation	4.5% 1/22 • Number of events 1 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Immune system disorders Anaphylaxis	4.5% 1/22 • Number of events 1 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Infections and infestations Lymph gland infection	4.5% 1/22 • Number of events 1 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.

Other adverse events

Other adverse events
Measure	Treatment (TAS-102, Oxaliplatin) n=22 participants at risk Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery. Trifluridine and Tipiracil Hydrochloride: Given PO Oxaliplatin: Given IV
Blood and lymphatic system disorders Anemia	9.1% 2/22 • Number of events 2 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Cardiac disorders Sinus tachycardia	13.6% 3/22 • Number of events 3 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Abdominal pain	13.6% 3/22 • Number of events 3 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Bloating	9.1% 2/22 • Number of events 2 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Constipation	50.0% 11/22 • Number of events 11 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Diarrhea	40.9% 9/22 • Number of events 9 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Dyspepsia	9.1% 2/22 • Number of events 2 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Flatulence	9.1% 2/22 • Number of events 2 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Mucositis oral	13.6% 3/22 • Number of events 3 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Nausea	59.1% 13/22 • Number of events 13 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Oral dysesthesia	9.1% 2/22 • Number of events 2 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Vomiting	36.4% 8/22 • Number of events 8 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
General disorders Fatigue	59.1% 13/22 • Number of events 13 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Gastrointestinal disorders Fever	13.6% 3/22 • Number of events 3 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Injury, poisoning and procedural complications Infusion related reaction	18.2% 4/22 • Number of events 4 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Investigations Lymphocyte count decreased	9.1% 2/22 • Number of events 2 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Investigations Neutrophil count decreased	22.7% 5/22 • Number of events 5 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Investigations Platelet count decreased	13.6% 3/22 • Number of events 3 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Investigations White blood cell decreased	9.1% 2/22 • Number of events 2 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Metabolism and nutrition disorders Anorexia	27.3% 6/22 • Number of events 6 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Musculoskeletal and connective tissue disorders Back pain	13.6% 3/22 • Number of events 3 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Nervous system disorders Dysesthesia	22.7% 5/22 • Number of events 5 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Nervous system disorders Dysgeusia	22.7% 5/22 • Number of events 5 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Nervous system disorders Headache	9.1% 2/22 • Number of events 2 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Nervous system disorders Peripheral sensory neuropathy	31.8% 7/22 • Number of events 7 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Psychiatric disorders Insomnia	13.6% 3/22 • Number of events 3 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 2/22 • Number of events 2 • Adverse events were monitored up to 30 days after surgery, which is expected to be 50 days and a maximum of 210 days. All cause mortality was monitored up to two years.

Additional Information

Kris Attwood

Roswell Park Comprehensive Cancer Center

Phone: 716-845-2300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place