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

NCT06564298 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2024-08-28

No results posted yet for this study

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.

Conditions

  • Stomach Neoplasms

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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-12-31
Completion
2026-06-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06564298 on ClinicalTrials.gov