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

Last updated: February 9, 2026
Sponsor: Akeso
Overall Status: Active - Recruiting

Phase

3

Condition

Adenocarcinoma

Treatment

SOX chemotherapy

Cadonilimab

Placebo

Clinical Study ID

NCT07023315
AK104-310
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with histologically confirmed gastric or gastroesophageal junctionadenocarcinoma with resectable disease (clinical stage T3-4aN+M0 or T4bNanyM0 perAJCC 8th edition).

  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 atenrollment.

  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

Exclusion Criteria:

  1. Patients with unresectable locally advanced disease or distant metastasis.

  2. Histopathology or cytology confirmed other pathological types, such as adenosquamouscell carcinoma, squamous cell carcinoma, or GI stromal tumor.

  3. Current or prior use of immunosuppressive medication within 14 days beforerandomization.

  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 activetreatment within the past 5 years.

  8. Has an active autoimmune disease that has required systemic treatment in past 2years.

  9. Known active Hepatitis B or Hepatitis C virus infection.

  10. Has had an allogenic tissue/solid organ transplant.

Study Design

Total Participants: 760
Treatment Group(s): 3
Primary Treatment: SOX chemotherapy
Phase: 3
Study Start date:
August 14, 2025
Estimated Completion Date:
July 31, 2031

Study 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.

Connect with a study center

  • Peking University Cancer Hospital

    Beijing, Beijing 100143
    China

    Site Not Available

  • Peking University Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100143
    China

    Active - Recruiting

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Fujian Provincial Cancer Hospital

    Fuzhou 1810821, Fujian 1811017
    China

    Active - Recruiting

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang 1795270, Hebei 1808773
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin 2037013, Heilongjiang 2036965
    China

    Active - Recruiting

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

  • Zhongshan Hospital, Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231
    China

    Active - Recruiting

  • Tianjin Provincial Tumor Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Tianjin Provincial Tumor Hospital

    Tianjin 1792947, Tianjin Municipality 1792943
    China

    Active - Recruiting

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