Shr-1701 with or without Apatinib plus chemotherapy as neoadjuvant treatment for gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized Phase 2 trial in adults with resectable, locally advanced gastric or GEJ adenocarcinoma (cT3-4aN+M0). Participants are assigned 1:1 to two treatment arms: SHR-1701 with apatinib plus SOX chemotherapy, or SHR-1701 with SOX alone. A safety run-in is planned for the first six patients in the apatinib-containing arm to monitor early safety signals. The study aims to assess tumor response and safety during neoadjuvant therapy prior to planned surgical resection.

Why it matters

Who can join: the full rules

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)

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiaofeng Chen, MD
• Email: chenxiaofengnimu@163.com
• Phone: 0086-13585172066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.