A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma
NCT ID: NCT07023315
Last Updated: 2025-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
760 participants
INTERVENTIONAL
2025-07-31
2031-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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cadonilimab+SOX
Cadonilimab plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)
Cadonilimab
Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
SOX chemotherapy
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
Placebo+SOX
Placebo plus Oxaliplatin and Tegafur-Gimeracil-Oteracil Potassium (SOX)
SOX chemotherapy
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
Interventions
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Cadonilimab
Anti-PD-1/ CTLA-4 tetrameric bispecific antibody
SOX chemotherapy
A combination treatment made up of oxaliplatin and tegafur-gimeracil-oteracil potassium
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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AK104-310
Identifier Type: -
Identifier Source: org_study_id
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