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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma
• Intervention / Treatment: Drug: Camrelizumab; Drug: S-1, Oxaliplatin; Drug: Apatinib

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chengdu, China
    • Sichuan Cancer Hospital & Institute
  • Shanghai, China
    • Changhai Hospital
  • Yantai, China
    • Yantai Yuhuangding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3-4N+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 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.
6. 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:

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 despite antihypertensive 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab and Apatinib and S-1 and Oxaliplatin	Drug: Camrelizumab; Camrelizumab 200mg; Drug: S-1, Oxaliplatin; S-1, Oxaliplatin, q3w; Drug: Apatinib; Apatinib 250mg
Experimental: Camrelizumab and S-1 and Oxaliplatin	Drug: Camrelizumab; Camrelizumab 200mg; Drug: S-1, Oxaliplatin; S-1, Oxaliplatin, q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR)	Defined as the percentage of subjects with no residual tumor cells in the primary tumor (Becker Grade 1a)	Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
AEs	Up to approximately 18 months
Major pathological response (MPR)	Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
total Pathologic complete response (tpCR)	Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
R0 resection rate	Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment
Event free survival (EFS)	Up to approximately 3 years
Disease-free survival (DFS)	Up to approximately 3 years
Overall survival(OS)	Up to approximately 5 years
Pathologic Nodal Stage after Neoadjuvant Therapy	Up to 6 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Zhenggang Zhu, Ruijin Hospital; Principal Investigator: Yantao Tian, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Organic Chemicals; Coordination Complexes; Oxaliplatin; camrelizumab; apatinib; S 1 (combination)
• Other Study ID Numbers: MA-GC-II-019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No