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
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- West China Hospital
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- pCR rate
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-75 years.
- •Histologically or cytologically confirmed diagnosis of locally advanced G/GEJ adenocarcinoma (cT3N+/T4aNany M0) as assessed by exploratory laparoscopic surgery, ultrasonography and/or CT/MRI.
- •Resectable G/GEJ cancer, as judged by experienced surgeons.
- •There was no previous antitumor treatment.
- •The expected survival is more than 3 months.
- •Adequate organ function including the following:
- •Total bilirubin ≤1.5 times the upper limit of normal (ULN);
- •Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN;
- •Alkaline phosphatase≤2.5×ULN (if the tumor invaded the liver, ≤3×ULN);
- •Serum creatinine≤1.5×ULN;
Exclusion Criteria
- •Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.
- •Active autoimmune disease or history of refractory autoimmune disease.
- •Receiving corticosteroids (\> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.
- •Active or clinically significant cardiac disease:
- •Congestive heart failure \> New York Heart Association (NYHA) class 2;
- •Active coronary artery disease;
- •Arrhythmias requiring treatment other than β-blockers or digoxin;
- •Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment
- •Evidence or history of bleeding diathesis or coagulopathy.
- •Grade 3 bleeding events 4 weeks before enrollment.
Arms & Interventions
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.
Intervention: Chemotherapy plus sintilimab and bevacizumab (Drug)
Outcomes
Primary Outcomes
pCR rate
Time Frame: 6 months after the last subject participating in
defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy
Secondary Outcomes
- MPR rate(6 months after the last subject participating in)
- R0 resection rate(6 months after the last subject participating in)
- Event-free survival(2 years after the last subject participating in)
- Overall survival(2 years after the last subject participating in)
- Treatment-related adverse events(3 months after the last administration of drugs)
Investigators
Ming Liu
PI
West China Hospital