NCT06667050

CAPOX Plus Sintilimab and Bevacizumab Biosimilar (IBI305) for Neoadjuvant Treatment of Locally Advanced Gastric Cancer

CAPOX Combined with Sintilimab and Bevacizumab Biosimilar (IBI305) for Neoadjuvant Treatment of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: a Prospective, Multi-center, Single-arm, Phase II Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Neoadjuvant chemotherapy has been recommended by a series of treatment guidelines for the neoadjuvant treatment of locally advanced G/GEJ cancer. Although with clinical efficacy, the pCR and long-term survival rates are still unsatisfactory and perioperative treatment mode for locally advanced G/GEJ cancer still needs further optimization. In this study, we will explore the efficacy and safety of chemotherapy combined with sintilimab and bevacizumab biosimilar (IBI305) in the neoadjuvant treatment for locally advanced G/GEJ cancer.

Detailed description

This is a prospective, multicenter, single-arm, phase II trial. A total of 58 patients will be enrolled. Eligible patients will be registered and receive three cycles of CAPOX plus sintilimab and bevacizumab biosimilar (IBI305) regimen. Radical D2 gastric cancer resection will be performed 6-8 weeks after the last administration of chemotherapy plus plus sintilimab and bevacizumab biosimilar (IBI305). The primary endpoint of the study is the pathological complete response (pCR) rate. Secondary endpoints include R0 resection rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS) and safety profile of the neoadjuvant regimen.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Chemotherapy plus sintilimab and bevacizumab	Laparoscopic exploration should be performed to detect occult peritoneal metastases and inspect the primary lesion, liver, diaphragm, pelvic organs, bowel and omentum. 3 cycles of neoadjuvant therapy will be administered: capecitabine: 100 mg/m2, Bid, d1-14, q3w; oxaliplatin: 130 mg/m2, iv drip, d1, q3w; sintilimab: 200 mg, iv drip, d1, bevacizumab biosimilar (IBI305) 10mg /Kg, iv drip, d1, q3w. Radical D2 gastric cancer resection will be performed within 6-8 weeks after the last administration of chemotherapy plus sintilimab and bevacizumab biosimilar (IBI305). The adjuvant therapy will start in 4-6 weeks after the surgery, and we recommend adjuvant treatment with CAPOX regimen for up to 3 cycles.

Timeline

• Start date: 2024-10-10
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2024-10-31
• Last updated: 2024-10-31

Locations

1 site across 1 country: China