Not Yet RecruitingPhase 2

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

80 participantsStarted 2026-04-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

Pathological Complete Response (pCR)

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

Trial details

NCT IDNCT07464756

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05-31

View on ClinicalTrials.gov More Gastric Adenocarcinoma trials