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

NCT06693128 | Active Not Recruiting Phase 2

• 1 other identifier: MA-GC-II-019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• Pathologic Nodal Stage after Neoadjuvant Therapy

  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

Study Arms (2)

Camrelizumab and Apatinib and S-1 and Oxaliplatin

EXPERIMENTAL

Drug: Camrelizumab; Drug: Apatinib; Drug: S-1, Oxaliplatin

Camrelizumab and S-1 and Oxaliplatin

EXPERIMENTAL

Drug: Camrelizumab; Drug: S-1, Oxaliplatin

Interventions

Camrelizumab DRUG

Camrelizumab 200mg

Camrelizumab and Apatinib and S-1 and Oxaliplatin; Camrelizumab and S-1 and Oxaliplatin

Apatinib DRUG

Apatinib 250mg

Camrelizumab and Apatinib and S-1 and Oxaliplatin

S-1, Oxaliplatin DRUG

S-1, Oxaliplatin, q3w

Camrelizumab and Apatinib and S-1 and Oxaliplatin; Camrelizumab and S-1 and Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (3)

Sichuan Cancer Hospital & Institute

Chengdu, China

Location

Changhai Hospital

Shanghai, China

Location

Yantai Yuhuangding Hospital

Yantai, China

Location

MeSH Terms

Conditions

Adenocarcinoma

Interventions

camrelizumab; apatinib; S 1 (combination); Oxaliplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Zhenggang Zhu

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Yantao Tian

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: November 21, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (3)