NCT06118645

Cadonilimab+ Paclitaxel (Albumin-bound) Treat Advanced Gastric Adenocarcinoma With PD-(L)1 Inhibitors Resistance

An Open, Multicenter, Phase II Study of Cadonilimab Combined With Paclitaxel (Albumin-bound) in the Treatment of Advanced Gastric Adenocarcinoma or Esophagogastric Junction Adenocarcinoma With PD-(L)1 Inhibitors Resistance

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Cadonilimab combined with paclitaxel (albumin-bound) treat advanced gastric adenocarcinoma or esophagogastric junction adenocarcinoma with PD-(L)1 inhibitors resistance

Detailed description

An open, multicenter, Phase II study of cadonilimab combined with paclitaxel (albumin-bound) in the treatment of advanced gastric adenocarcinoma or esophagogastric junction adenocarcinoma that has failed prior treatment with PD-(L)1 inhibitors

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	cadonilimab combined +paclitaxel (albumin-bound)	1. In the safe induction phase6 subjects will receive cadonilimab (10mg/kg, Q3W, intravenous infusion, up to 2 years) and paclitaxel (albumin-bound type)(125 mg/m2,Days1, 8,Q3w, intravenous infusion, up to 8 cycles). 2. If the safety and tolerability are good, and the initial efficacy signal is observed, the extended enrollment phase will enter the extended enrollment phase of drug administration and the safety introduction phase

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-09-01
• Completion: 2026-08-01
• First posted: 2023-11-07
• Last updated: 2023-11-07