drugset / Trial / NCT05669807

Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

NCT05669807 ↗

Phase 2 Unknown 184 enrolled Zhejiang Cancer Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.

Timeline

Start
2022-12
Primary completion
2023-11
Completion
2025-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin-Bound Paclitaxel Unknown 100 mg/m2 —
Subject Camrelizumab Monoclonal antibody 200 mg —
Subject Irinotecan Small molecule 180 mg/m2 —

Indications

No indication recorded.