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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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 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.
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning, China
RECRUITINGProgression-free survival (PFS)
To evaluate the efficacy of anti-tumor by Resist1.1 (In months)
Time frame: From the date of first treatment until the date of first documented disease progression (assessed per RECIST 1.1) or death from any cause, whichever occurs first, assessed up to 24 months.
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor by Resist1.1
Time frame: From the start of treatment until the first occurrence of documented complete response (CR) or partial response (PR) per RECIST 1.1, assessed up to 24 month
Disease control rate (DCR)
To evaluate the efficacy of anti-tumor by Resist 1.1 (In percent)
Time frame: From the start of treatment until the first documented complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1, assessed up to 24 months.
Overall survival (OS)
To evaluate the efficacy of anti-tumor by Resist 1.1 (In months)
Time frame: From the date of first treatment until the date of death from any cause, assessed up to 36 months
Safety
Incidence and severity of treatment-emergent adverse events (TEAEs).
Time frame: From the first dose of study treatment until 30 days after the last dose, assessed up to approximately 26 months.
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