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

Sponsor
West China Hospital
Study ID
NCT06667050
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy plus sintilimab and bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Oct 31, 2024
Start date
Oct 10, 2024
Status verified
Oct 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
58 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: chemotherapy plus sintilimab and bevacizumab biosimilar
    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.

Primary Outcome Measure

pCR rate [ Time Frame: 6 months after the last subject participating in ]

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