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OpenTrials
Active, Not Recruiting

NCT Number: NCT06693128

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sichuan Cancer Hospital & Institute, Chengdu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+M0 (according to AJCC 8th edition) ;
  • Plans to proceed to surgery after completion of neoadjuvant therapy;
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • Has adequate organ function.
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose, and be willing to use a highly effective method of contraception during the study and for 2 months after the last dose of carrelizumab or 8 weeks after apatinib or 6 months after chemotherapy drugs, whichever is longer.
  • Male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use highly effective methods of contraception during the study and for 2 months after the last administration of carrilizumab or 8 weeks after apatinib or 3 months after chemotherapy drugs, whichever is longer. Sperm donation is not allowed during the study.

Exclusion criteria

  • Known HER2 positive;
  • Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);
  • Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast;
  • Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy);
  • Known hypersensitivity to any of the study drugs or excipients;
  • Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.);
  • Congenital or acquired immune deficiency (e.g. HIV infected)

Treatment and study plan

Camrelizumab

Drug

Camrelizumab 200mg

apatinib

Drug

Apatinib 250mg

S-1, Oxaliplatin

Drug

S-1, Oxaliplatin, q3w

Primary outcomes

  1. Pathological Complete Response (pCR)

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

    Defined as the percentage of subjects with no residual tumor cells in the primary tumor (Becker Grade 1a)

Secondary outcomes

  1. Major pathological response (MPR)

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  2. total Pathologic complete response (tpCR)

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  3. R0 resection rate

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  4. Pathologic Nodal Stage after Neoadjuvant Therapy

    Time frame: Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

  5. Event free survival (EFS)

    Time frame: Up to approximately 3 years

  6. Disease-free survival (DFS)

    Time frame: Up to approximately 3 years

  7. Overall survival(OS)

    Time frame: Up to approximately 5 years

  8. AEs

    Time frame: Up to approximately 18 months

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Camrelizumab Combined With or Without Apatinib and SOX of Neoadjuvant Treatment for Resectable, Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Prospective, Exploratory II Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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