A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
A Randomized, Double-blind, Phase III Clinical Study Comparing the Efficacy and Safety of Cadonilimab Plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX) Versus Placebo Plus SOX as Perioperative Treatment for Patients With Resectable Gastric and Gastroesophageal Junction (G/GEJ) Adenocarcinoma
Akeso
760 participants
Aug 14, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- Has life expectancy of at least 6 months.
- Availability of tumor sample prior to study entry.
- Patients must undergo radical surgery.
- Has adequate organ function.
Exclusion Criteria10
- Patients with unresectable locally advanced disease or distant metastasis.
- Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
- Current or prior use of immunosuppressive medication within 14 days before randomization.
- Has received prior anti-cancer therapy for the current malignancy.
- Has an active infection requiring systemic therapy.
- Contra-indication to any of the study drugs.
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Known active Hepatitis B or Hepatitis C virus infection.
- Has had an allogenic tissue/solid organ transplant.
Interventions
Placebo
Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07023315