Actively Recruiting
A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
Led by Akeso · Updated on 2026-02-11
760
Participants Needed
6
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study investigates treatment of cadonilimab or placebo combined with SOX chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with SOX chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.
CONDITIONS
Official Title
A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed resectable gastric or gastroesophageal junction adenocarcinoma (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
- Life expectancy of at least 6 months
- Availability of tumor sample before study entry
- Willingness to undergo radical surgery
- Adequate organ function
You will not qualify if you...
- Unresectable locally advanced disease or distant metastasis
- Other pathological types such as adenosquamous cell carcinoma, squamous cell carcinoma, or gastrointestinal stromal tumor
- Use of immunosuppressive medication within 14 days before randomization
- Prior anti-cancer therapy for the current malignancy
- Active infection requiring systemic therapy
- Contraindication to any study drugs
- Known additional malignancy progressing or treated within past 5 years
- Active autoimmune disease requiring systemic treatment within past 2 years
- Known active Hepatitis B or C virus infection
- History of allogenic tissue or solid organ transplant
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100143
Actively Recruiting
2
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
3
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
4
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
5
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
6
Tianjin Provincial Tumor Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
Z
Zhifang Yao, MD
CONTACT
J
Jiafu Ji, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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