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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SHR-1701
  • apatinib
  • S-1 & Oxaliplatin

Treatment groups

80 Participants
are divided into 2 treatment groups