SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer

NCT07464756 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-GC-II-028
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter, randomized, two-cohort clinical trial to evaluate the efficacy and safety of SHR-1701 with or without apatinib in combined with chemotherapy of neoadjuvant treatment for resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Conditions

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

Secondary Outcomes (7)

• Tumor Regression Grade (TRG)

  Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

• ypN staging

  Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

• R0 resection rate

  Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

• Event free survival (EFS)

  Up to approximately 4 years

• Disease-free survival (DFS)

  Up to approximately 4 years

Study Arms (2)

SHR-1701, apatinib, and SOX

EXPERIMENTAL

Drug: SHR-1701; Drug: apatinib; Drug: S-1 & Oxaliplatin

SHR-1701 and SOX

EXPERIMENTAL

Drug: SHR-1701; Drug: S-1 & Oxaliplatin

Interventions

SHR-1701 DRUG

SHR-1701, 1800mg, Q3w

SHR-1701 and SOX; SHR-1701, apatinib, and SOX

apatinib DRUG

apatinib 250mg，Q3W

SHR-1701, apatinib, and SOX

S-1 & Oxaliplatin DRUG

S-1, Oxaliplatin, Q3w

SHR-1701 and SOX; SHR-1701, apatinib, and SOX

Eligibility Criteria

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

You may qualify if:

• Patients voluntarily participate in this study and provide signed informed consent;
• Age ≥18 years old;
• Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);
• Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable
• No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
• Plan to proceed to surgery after completion of neoadjuvant therapy;
• Able to swallow tablets normally;
• Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
• Estimated life expectancy ≥12 months;
• 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 must agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 6 months after chemotherapy (whichever is longer). Male subjects with partners of childbearing potential must be surgically sterile or agree to use a highly effective method of contraception during the study and for 3 months after the last dose of SHR-1701, or 8 weeks after apatinib, or 3 months after chemotherapy (whichever is longer), and must not donate sperm during the study.

You may not qualify if:

• Known HER2 positive
• Need transthoracic surgical approach Based on the investigator's judgment
• Known peritoneal metastasis or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition); 4 Presence of unresectable factors, including unresectability due to tumor-related reasons, contraindications to surgery, or refusal of surgery;
• \. Previous or concurrent malignancies, except for cured basal cell carcinoma of skin, carcinoma in situ of cervix, and carcinoma in situ of breast; 6. Uncontrolled hypertension ( systolic ≥140 mmHg or diastolic ≥90 mmHg despite antihypertensive therapy)； 7. Known hypersensitivity to any of the study drugs or excipients; 8. Known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders, thrombocytopenia, etc.); 9. Congenital or acquired immune deficiency (e.g. HIV infected)

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Interventions

SHR-1701; apatinib; S 1 (combination); Oxaliplatin

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

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: March 8, 2026
• First Posted: March 11, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): July 31, 2030
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share