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NOT YET RECRUITING
NCT06564298
PHASE2

A Study on the Combination of Sintilimab, Ramucirumab and Chemotherapy for First-line Treatment of Gastric Cancer With Liver Metastasis

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to observe the efficacy and safety of Sintilimab (a PD-1 inhibitor) combined with Ramucirumab (a VEGFR-2 antagonist) and chemotherapy as a first-line treatment for patients with advanced gastric cancer with liver metastasis. * Can the combination of Sintilimab, Ramucirumab, and chemotherapy improve the prognosis of patients with AGC and liver metastases? * What are the adverse events (AEs) associated with the use of the combination regimen of Sintilimab, Ramucirumab, and chemotherapy in patients with AGC and liver metastases? Participants will: * Receive a combined treatment regimen of Sintilimab, Ramucirumab, and chemotherapy (SOX (oxaliplatin and S-1) or XELOX (oxaliplatin and capecitabine)), administered every 21 days for up to 6 cycles. Following the completion of 6 cycles, maintenance therapy with Sintilimab and oral chemotherapy agents (capecitabine or S-1) with or without Ramucirumab will be administered until disease progression. * Imaging assessments will be performed at baseline, after every 2 cycles of treatment, and every 3 months following the completion of 6 cycles of treatment.

Official title: Sintilimab Combined With Ramucirumab and Chemotherapy as First-line Treatment in Patients With Advanced Gastric Cancer With Liver Metastasis (RAMSINT): A Phase II, Single-center, Prospective Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2024-08

Completion Date

2026-06

Last Updated

2024-08-28

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

Sintilimab 200mg iv.gtt d1, every 21 days

DRUG

Ramucirumab

Ramucirumab 10mg/kg iv.gtt d1, every 21 days

DRUG

SOX/XELOX

SOX: Oxaliplatin 130mg/m2 iv.gtt d1, every 21 days and S-1 40mg/m2 po bid d1-14, every 21 days XELOX: Oxaliplatin 130mg/m2 iv.gtt d1, every 21 days and Capecitabine 1000mg/m2 po bid d1-14, every 21 days