NCT06711471

Trifluridine/tipiracil (TAS-102), Bevacizumab, and Camrelizumab As Third-line or Later-line Therapy of Gastric Cancer

Phase II Study of Trifluridine/tipiracil (TAS-102), Bevacizumab, and Camrelizumab As a Third-line or Later-line Therapy for Patients with Metastatic Gastric Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: LIN YANG · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For patients with metastatic gastric cancer, the efficacy of current standard treatments outlined in the guidelines is far from meeting the clinical demand. This study aims to explore the efficacy and safety of trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab as a novel third-line or later-line therapy for metastatic gastric cancer patients.

Detailed description

This study is an explorative prospective phase II clinical study. The study recruits patients with advanced gastric/gastroesophageal junction adenocarcinoma who have experienced disease progression after at least two lines of systemic therapy. Participants must undergo screening tests within 28 days before treatment to determine their eligibility for the study. Patients who meet the inclusion criteria will receive treatment with trifluridine and tipiracil combined with bevacizumab and camrelizumab, with a treatment cycle of 14 days until disease progression, death, intolerable toxicity, or other criteria for terminating study treatment as specified in the protocol (whichever occurs first). Tumor assessment will be conducted according to the RECIST 1.1 criteria. It will be performed by the researcher or designated research staff every 3 cycles after the start of treatment, until disease progression, death, the initiation of other anti-tumor treatments, or withdrawal of informed consent. Safety follow-up will be conducted after the last dose to monitor the resolution of adverse events. After treatment termination, participants will be followed up for survival every 90 days until death or loss of follow-up.

Conditions

• Gastric Cancer Adenocarcinoma Metastatic

Interventions

Type	Name	Description
DRUG	trifluridine/tipiracil (TAS-102), bevacizumab plus camrelizumab	Patients enrolled in this study will receive trifluridine/tipiracil in combination with bevacizumab and camrelizumab, with a treatment cycle of 14 days, until disease progression, death, intolerable toxicity, or other criteria for discontinuation of study treatment as specified in the protocol (whichever occurs first).

Timeline

• Start date: 2024-11-14
• Primary completion: 2026-11-13
• Completion: 2027-11-13
• First posted: 2024-12-02
• Last updated: 2024-12-02

Locations

1 site across 1 country: China