Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Gastric Cancer

Last updated: January 26, 2026
Sponsor: Ruijin Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Adenocarcinoma

Treatment

Camrelizumab

Apatinib

S-1, Oxaliplatin

Clinical Study ID

NCT06693128
MA-GC-II-019
  • Ages > 18
  • All Genders

Study Summary

This study is a multicenter, randomized, uncontrolled clinical trial to evaluate the efficacy and safety of camrelizumab combined with or without apatinib and SOX of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined byT3-4N+M0 (according to AJCC 8th edition) ;

  2. Plans to proceed to surgery after completion of neoadjuvant therapy;

  3. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.

  4. Has adequate organ function.

  5. Female subjects of childbearing potential must have a negative serum pregnancy testwithin 72 hours prior to the first dose, and be willing to use a highly effectivemethod of contraception during the study and for 2 months after the last dose ofcarrelizumab or 8 weeks after apatinib or 6 months after chemotherapy drugs,whichever is longer.

  6. Male subjects whose partners are women of reproductive age should be surgicallysterilized or agree to use highly effective methods of contraception during thestudy and for 2 months after the last administration of carrilizumab or 8 weeksafter apatinib or 3 months after chemotherapy drugs, whichever is longer. Spermdonation is not allowed during the study.

Exclusion

Exclusion Criteria:

  1. Known HER2 positive;

  2. Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);

  3. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin,carcinoma in situ of cervix, and carcinoma in situ of breast;

  4. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despiteantihypertensive therapy);

  5. Known hypersensitivity to any of the study drugs or excipients;

  6. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs,coagulation disorders, thrombocytopenia, etc.);

  7. Congenital or acquired immune deficiency (e.g. HIV infected)

Study Design

Total Participants: 80
Treatment Group(s): 3
Primary Treatment: Camrelizumab
Phase: 2
Study Start date:
November 21, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Sichuan Cancer Hospital & Institute

    Chengdu,
    China

    Site Not Available

  • Sichuan Cancer Hospital & Institute

    Chengdu 1815286,
    China

    Site Not Available

  • Changhai Hospital

    Shanghai,
    China

    Site Not Available

  • Changhai Hospital

    Shanghai 1796236,
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai,
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai 1787093,
    China

    Site Not Available

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