A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cadonilimab, SOX chemotherapy, Placebo.
- Who it may be relevant to
- Registry conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
This trial is a Phase 3 study. All patients are resectable gastric or gastroesophageal junction adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.
Interventions
- Drug Cadonilimab
Anti-PD-1/ CTLA-4 tetrameric bispecific antibody - Drug SOX chemotherapy
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium - Drug Placebo
Placebo
Primary outcome measures
- Event-free survival (EFS) [Time frame: Up to 5 years]
- Pathological Complete Response (pathCR) Rate [Time frame: Up to approximately 2 years]
Secondary outcome measures (3)
- Overall survival (OS) [Time frame: Up to 10 years]
- Disease-free Survival (DFS) [Time frame: Up to 5 years]
- Number of Participants Who Experience One or More Adverse Events (AEs) [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 6 centers
- Peking University Cancer Hospital — Beijing
- Fujian Provincial Cancer Hospital — Fuzhou
- Fourth Hospital of Hebei Medical University — Shijiazhuang
- Harbin Medical University Cancer Hospital — Harbin
- Zhongshan Hospital, Fudan University — Shanghai
- Tianjin Provincial Tumor Hospital — Tianjin
Identifiers
NCT: NCT07023315 · AK104-310