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โ† Trials
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A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma

RecruitingPhase 3Ages 18 Years - 75 YearsAllAkeso
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Cadonilimab
  • SOX chemotherapy
  • Placebo
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Where

6 sites
Peking University Cancer Hospital
Beijing, China
Fujian Provincial Cancer Hospital
Fuzhou, China
Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Harbin Medical University Cancer Hospital
Harbin, China
Zhongshan Hospital, Fudan University
Shanghai, China
Tianjin Provincial Tumor Hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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