NCT06349967

Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer

Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer: A Prospective, Multicenter, Single-arm, Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Currently, standard treatment options for gastric cancer failed to first-line treatment include monotherapy with paclitaxel/irinotecan/docetaxel/albumin paclitaxel, or paclitaxel combined with ramucirumab. However, the efficacy of these regimens is still far from satisfactory. The aim of the study is to evaluate the efficacy and safety of nab-paclitaxel combined with cadonilimab for the second-line treatment of advanced gastric cancer.

Detailed description

This trial is a prospective, multicenter, single arm, phase II clinical study. It is divided into three stages: screening period, treatment period, and follow-up period. The main research objective of this study is to evaluate the objective response rate (ORR) of albumin paclitaxel combined with kandelizumab (AK104) in second-line treatment of gastric cancer with failed first-line fluorouracil/platinum combination immunotherapy. Secondary study objective: To evaluate the disease control rate (DCR), progression free survival (PFS), overall survival (OS), safety, tolerability, and impact on patient quality of life (QoL) of albumin paclitaxel combined with candelizumab (AK104) in second-line treatment of gastric cancer with failed first-line fluorouracil/platinum immunotherapy.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel Combined With Cadonilimab (AK104)	Nab-paclitaxel 100mg/m2 ivgtt d1, d8, d15, q28d; Cadonilimab (AK104) 6mg/kg ivgtt d1, d15, q28d;

Timeline

• Start date: 2024-04-30
• Primary completion: 2027-04-30
• Completion: 2027-05-30
• First posted: 2024-04-05
• Last updated: 2024-04-05