A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT07023315
- Run by
- Akeso
- People needed
- 760
- Starts
- 2025-08-14
- Expected to finish
- 2031-07-01
- Last updated by the study team
- 2026-02-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Peking University Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
- Fujian Provincial Cancer Hospital — Fuzhou, Fujian, China (enrolling)
- Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
- Tianjin Provincial Tumor Hospital — Tianjin, Tianjin Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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