drugset
drugset / Trial / NCT06748508

Comparing the Efficacy of Sintilimab Plus Nab-POF Regimen, Sintilimab Plus XELOX Chemotherapy, and Lenvatinib, Sintilimab Plus XELOX Chemotherapy in the Treatment of HER2-negative, Metastatic Gastric Cancer

NCT06748508 ↗

Phase 2 Not yet recruiting 141 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is a prospective, open, randomized, phase II clinical study. It compares the current first-line treatment for advanced gastric cancer in phase II clinical trials, with the best efficacy being the combination of orient-16 study with sintilimab and XELOX regimen. The purpose of this study is to evaluate whether adding anti-angiogenic drugs or chemotherapy drugs on the basis of two-drug chemotherapy regimen (XELOX regimen) and PD-1 monoclonal antibody can improve efficacy for advanced gastric cancer.

Timeline

Start
2024-12-25
Primary completion
2027-07-25
Completion
2027-12-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Nab-paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Sintilimab Monoclonal antibody 100 mg Intravenous
Subject Sintilimab Monoclonal antibody 200 mg Intravenous
Subject fluorouracil Small molecule 2.4 g Intravenous
Subject oxalipaltin Unknown 85 mg/m2 Intravenous
Subject oxalipaltin Unknown 130 mg/m2 Intravenous

Indications

gastric cancer