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

NCT06667050 | Active Not Recruiting Phase 2

• 1 other identifier: WCH241260
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• pCR rate

  defined as the absence of viable tumor cells assessed by histological evaluation criteria after neoadjuvant therapy

  6 months after the last subject participating in

Secondary Outcomes (5)

• R0 resection rate

  6 months after the last subject participating in

• MPR 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

Study Arms (1)

chemotherapy plus sintilimab and bevacizumab biosimilar

EXPERIMENTAL

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.

Drug: Chemotherapy plus sintilimab and bevacizumab

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.

chemotherapy plus sintilimab and bevacizumab biosimilar

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG PS≤1.
• 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;
• Serum amylase and lipase≤1.5×ULN;
• International standardized ratio (INR)/partial thromboplastin time (PTT)≤1.5×ULN;
• Platelet count ≥ 100,000 /mm3;
• Hemoglobin (Hb) ≥ 9 g/dL;

You may not qualify if:

• 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.
• Thromboembolism or arteriovenous events, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, occurred 6 months before enrollment.
• Currently taking anticoagulants.
• Gastrointestinal perforation, gastrointestinal obstruction, or uncontrollable diarrhea 6 months before enrollment.
• Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor was cured and no evidence of disease was found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
• Patients with pheochromocytoma.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Drug Therapy; sintilimab; Bevacizumab

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: October 31, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)