NCT06406426

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

An Open and Exploratory Study of The Second-line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma With Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric / Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab and Fruquintinib Combined With Paclitaxel-albumin	Cadonilimab : 6mg/kg (≤375mg) d1,15 s.c. Q4W; Fruquintinib: 3mg p.o. Q.d d1-21,Q4W.; Paclitaxel-albumin: 100 mg/m2 d1,8,15 stop for one week, i.v. Q4W

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-05-01
• Completion: 2026-09-01
• First posted: 2024-05-09
• Last updated: 2024-05-09

Locations

1 site across 1 country: China