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

A Prospective Exploratory Study of SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Adenocarcinoma
• Intervention / Treatment: Drug: SHR-1701; Drug: apatinib; Drug: S-1 & Oxaliplatin

Detailed Description

This study enroll patients with resectable, locally advanced (cT3-4aN+M0) gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have not received anticancer therapy. Eligible subjects will be randomized in a 1:1 ratio to one of the two intervention arms. Arm 1：SHR-1701, apatinib, and SOX. Arm2: SHR-1701 and SOX. Arm 1 incorporates a safety run-in phase, during which the first 6 subjects enrolled in this cohort will undergo safety observation.

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

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients voluntarily participate in this study and provide signed informed consent;
2. Age ≥18 years old;
3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert Type II and Type III adenocarcinoma are permitted);
4. Clinically staged as T3-4aN+M0 by CT or MRI (per AJCC 8th edition), deemed resectable
5. No prior antitumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);
6. Plan to proceed to surgery after completion of neoadjuvant therapy;
7. Able to swallow tablets normally;
8. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
9. Estimated life expectancy ≥12 months;
10. Has adequate organ function.
11. 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.

Exclusion Criteria:

1. Known HER2 positive
2. Need transthoracic surgical approach Based on the investigator's judgment
3. 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;

5. 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)

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: SHR-1701, apatinib, and SOX	Drug: SHR-1701; SHR-1701, 1800mg, Q3w; Drug: apatinib; apatinib 250mg，Q3W; Drug: S-1 & Oxaliplatin; S-1, Oxaliplatin, Q3w
Experimental: SHR-1701 and SOX	Drug: SHR-1701; SHR-1701, 1800mg, Q3w; Drug: S-1 & Oxaliplatin; S-1, Oxaliplatin, Q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological Complete Response (pCR)	Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Overall survival(OS)	Up to approximately 4 years
AEs	Up to approximately 3 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 5, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Coordination Complexes; Oxaliplatin; apatinib; SHR-1701; S 1 (combination)
• Other Study ID Numbers: MA-GC-II-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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