Study of The Second-line Treatment of Advanced Gastric / Gastroesophageal Junction Adenocarcinoma With Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin

• Status: RECRUITING
• Trial end date: 2026-09-01

Summary

This study is a prospective, open-label, two-arm exploratory Phase II clinical trial aimed at observing and evaluating the efficacy and safety of combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin as second-line treatment for advanced gastric/esophagogastric junction adenocarcinoma. Patients meeting the inclusion criteria were divided into two groups based on whether they had received PD-1/L1 antibody treatment in the first line: Group A (immunotherapy-naive group - patients who had previously failed standard chemotherapy in the first line) and Group B (immunotherapy rechallenge group - patients who had previously failed PD-1/L1 antibody combined chemotherapy in the first line). All patients received combined therapy with cadonilimab and fruquintinib in conjunction with paclitaxel-albumin until intolerable toxic reactions occurred, disease progression, withdrawal of informed consent by the subject, loss to follow-up, death, other conditions judged by the investigator to require termination of treatment, or termination of the study, whichever occurred first. The maximum duration of paclitaxel-albumin treatment was 6 cycles, and cadonilimab treatment did not exceed 1 year. Clinical tumor imaging evaluations were conducted every 8 weeks during treatment using RECIST v1.1 criteria, and safety assessments were performed using CTCAE 5.0, recording adverse events within 30 days from the first dose to the end of treatment.

• Phase: PHASE2

Details

• Lead Sponsor: Fudan University