Actively Recruiting
Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Led by Zuoyi Jiao · Updated on 2025-07-10
668
Participants Needed
4
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to investigate the efficacy and safety of neoadjuvant cadonilimab in combination with perioperative SOX chemotherapy, compared to perioperative SOX chemotherapy alone, in patients with diffuse or mixed-type locally advanced gastric or gastroesophageal junction adenocarcinoma. The main questions it seeks to answer are: 1. Is neoadjuvant cadonilimab plus SOX chemotherapy superior to neoadjuvant placebo plus SOX chemotherapy in terms of the pathological complete response (pCR) rate at the time of surgery? 2. To evaluate and compare the 3-year OS rate in patients receiving neoadjuvant cadonilimab plus SOX chemotherapy versus patients receiving placebo plus neoadjuvant SOX chemotherapy regimen. Participants will be divided into two groups: 1. Experimental group: Participants will receive intravenous cadonilimab (10 mg/kg) in combination with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). 2. Control group: Participants will receive a placebo in combination with the SOX regimen. After completing 3-4 cycles of treatment, patients in both the experimental and control groups will undergo radical surgery with D2 or D2+ lymphadenectomy. Following surgery, patients will receive 4 cycles of adjuvant SOX chemotherapy at 70% of the standard dosage, administered every 21 days, starting within 3-6 weeks post-surgery.
CONDITIONS
Official Title
Neoadjuvant Cadonilimab Combined With Perioperative Oxaliplatin Plus S1 for Diffuse or Mixed Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed HER-2 negative diffuse or mixed type gastric or gastroesophageal junction adenocarcinoma
- Locally advanced disease (stage cT2-cT4) with N1-N3 lymph nodes and no metastasis
- Eligible Siewert type 2 or 3 tumors; limited Siewert type 1 tumors planned for perioperative chemotherapy and surgery
- Age between 18 and 75 years at consent
- Expected survival of at least 12 weeks
- ECOG performance status of 0 or 1
- Male participants sexually active with female partners of childbearing potential must use effective contraception from Day 1 through 120 days after last study dose
- Female participants of childbearing potential must use adequate contraception throughout the study and for 120 days after last study dose
- Adequate blood counts and organ function as specified
- No blood transfusion within 14 days prior to treatment
- No myocardial infarction within 6 months; controllable hypertension or coronary heart disease
- Written informed consent provided
- No prior anti-tumor treatments
- Plan to proceed to surgery after pre-operative chemotherapy
- Willing to provide tumor tissue and blood samples at baseline and surgery
You will not qualify if you...
- History of pneumonitis requiring steroids or current pneumonitis
- Active infection requiring systemic therapy
- Active autoimmune disease requiring systemic treatment in past 2 years (exceptions apply)
- Use of systemic corticosteroids (>10 mg/day prednisone) or immunosuppressants within 14 days prior to treatment
- Primary immunodeficiency
- Live vaccine or other immune-activating anti-tumor drugs within 30 days prior to first dose
- Known active tuberculosis
- History of allogeneic organ or hematopoietic stem cell transplantation
- Severe allergy or hypersensitivity to cadonilimab, sintilimab, chemotherapy agents, or excipients
- Certain cardiovascular or cerebrovascular diseases or risk factors including severe myocardial ischemia, poorly controlled arrhythmia, advanced cardiac insufficiency, or low left ventricular ejection fraction
- Enrollment in another clinical interventional study or recent participation within specified washout periods
- Prior systemic or curative anti-tumor therapy
- Prior treatment with immune checkpoint inhibitors or T-cell co-stimulation pathway therapies
- Confirmed HER-2 positive tumor
- Unable to provide tumor and blood samples
- Pregnant or lactating, or planning pregnancy within 5 months; female participants must have a negative pregnancy test within 7 days before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
2
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
3
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Actively Recruiting
4
The Gastrointestinal Surgery Department, Sun Yat-sen University Cancer Center Gansu Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
Research Team
B
Bo Long
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here