NCT07311408

SHR-1701 + Rivoceranib (± SHR-2554) in Advanced GC After First-Line Immunotherapy Failure

SHR-1701 Combined With Rivoceranib, With or Without SHR-2554, in Patients With Advanced Gastric Cancer Who Have Failed First-Line Immunotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jingdong Zhang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy of SHR-1701 combined with Rivoceranib, with or without SHR-2554, in patients with gastric or gastroesophageal junction adenocarcinoma who have progressed on or were intolerant to first-line immunotherapy-containing treatment

Detailed description

This is a prospective, open-label, dual-cohort, Phase II clinical study designed to observe and evaluate the efficacy and safety of SHR-1701 combined with Rivoceranib, with or without SHR-2554, in patients with advanced gastric cancer who have failed first-line immunotherapy. The study targets patients with gastric or gastroesophageal junction adenocarcinoma who have progressed on or are intolerant to first-line immunotherapy-containing regimens. Eligible subjects who provide informed consent and pass screening will be randomized in a 1:1 ratio to receive the study treatment. Cohort 1: SHR-1701+ Rivoceranib+ SHR-2554；Cohort 2: SHR-1701 + Rivoceranib. Primary Endpoint (based on RECIST v1.1): Progression Free Survival (PFS); Secondary Endpoints (based on RECIST v1.1): Objective Response Rate (ORR); Duration of Response (DoR); Overall Survival (OS); Safety; Exploratory Endpoint: Multi-omics analysis of the tumor microenvironment (including, but not limited to, ctDNA and TMB). Official Title：A Prospective, Dual-Cohort, Phase II Clinical Study of SHR-1701 Combined with Rivoceranib With or Without SHR-2554 in Patients with Advanced Gastric Cancer Who Failed First-Line Immunotherapy

Conditions

• Gastric Cancer (GC)
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	SHR-1701+Rivoceranib + SHR-2554	Drug: SHR-1701 Administered by intravenous (IV) infusion on Day 1 of each 21-day cycle. The infusion time should be controlled between 30 and 60 minutes, and must not exceed 2 hours. Drug: Rivoceranib Administered orally (PO) once daily (QD), continuously. Administration Instructions: To be taken orally with warm water, approximately 30 minutes after a meal. The daily dosing time should be consistent. Drug: SHR-2554 Administered orally (PO) twice daily (BID). Administration Instructions: Can be taken before or after meals, but administration approximately 30 minutes after morning and evening meals is recommended. The daily dosing times should be consistent.
DRUG	SHR-1701 + Rivoceranib	Drug: SHR-1701 Administered by intravenous (IV) infusion on Day 1 of each 21-day cycle. The infusion time should be controlled between 30 and 60 minutes, and must not exceed 2 hours. Drug: Rivoceranib Administered orally (PO) once daily (QD), continuously. Administration Instructions: To be taken orally with warm water, approximately 30 minutes after a meal. The daily dosing time should be consistent.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-01-01
• Completion: 2029-12-01
• First posted: 2025-12-31
• Last updated: 2025-12-31

Locations

1 site across 1 country: China