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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients with diagnosed by tissue sample (biopsy-confirmed) gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition). 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 3. Has expected to live at least 6 months. 4. Availability of tumor sample prior to study entry. 5. Patients must undergo radical surgery. 6. Has your organs (liver, kidneys, etc.) are working well enough based on blood tests. Who Should NOT Join This Trial: 1. Patients with unresectable locally advanced disease or distant metastasis. 2. Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor. 3. Current or prior use of immunosuppressive medication within 14 days before randomization. 4. Has received prior anti-cancer therapy for the current malignancy. 5. Has an active infection requiring systemic therapy. 6. Contra-indication to any of the study drugs. 7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. 8. Has an active autoimmune conditions (where your immune system attacks your own body) that has required systemic treatment in past 2 years. 9. Known active Hepatitis B or Hepatitis C virus infection. 10. Has had an allogenic tissue/solid organ transplant. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 per AJCC 8th edition). 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment. 3. Has life expectancy of at least 6 months. 4. Availability of tumor sample prior to study entry. 5. Patients must undergo radical surgery. 6. Has adequate organ function. Exclusion Criteria: 1. Patients with unresectable locally advanced disease or distant metastasis. 2. Histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor. 3. Current or prior use of immunosuppressive medication within 14 days before randomization. 4. Has received prior anti-cancer therapy for the current malignancy. 5. Has an active infection requiring systemic therapy. 6. Contra-indication to any of the study drugs. 7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. 8. Has an active autoimmune disease that has required systemic treatment in past 2 years. 9. Known active Hepatitis B or Hepatitis C virus infection. 10. Has had an allogenic tissue/solid organ transplant.

Treatments Being Tested

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

Locations (6)

Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Provincial Tumor Hospital
Tianjin, Tianjin Municipality, China