NCT05853172

Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer

Surgical Conversion of Candonilimab (AK104) Combined With Paclitaxel, S-1 and Apatinib for Unresectable Advanced Gastric(G)/Gastroesophageal Junction(GEJ) Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, open-label，single-center, phase II study, aiming to to evaluate the surgical conversion feasibility of AK104 combined with apatinib, paclitaxel and S-1 in unresectable stage IV G/GEJ cancer.

Detailed description

Eligible patients receive AK104 (10mg/kg, iv, Q3W) combined with apatinib (250mg, po, qd), paclitaxel (non-peritoneal metastasis: 130mg/m2, iv, D1; peritoneal metastasis :90mg/m2, iv, 40mg/m2, ip, D1) and S-1(60mg, po, bid, D1-D14) for up to 6 cycles. Patients assessed by Multi-Disciplinary Treatment (MDT) to meet the criteria for surgical resection undergo gastrectomy.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	AK104	Subjects will receive AK104 until disease progression or for up to 6 cycles.
DRUG	Apatinib	Subjects will receive apatinib until disease progression or for up to 6 cycles.
DRUG	Paclitaxel	Subjects will receive paclitaxel until disease progression or for up to 6 cycles.
DRUG	S-1	Subjects will receive S-1 until disease progression or for up to 6 cycles.

Timeline

• Start date: 2023-03-21
• Primary completion: 2025-03-21
• Completion: 2025-12-21
• First posted: 2023-05-10
• Last updated: 2023-05-10

Locations

1 site across 1 country: China