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

Sponsor
Jingdong Zhang
Study ID
NCT07311408
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastric Cancer (GC)
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHR-1701+Rivoceranib + SHR-2554 — DRUG
    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.
  • SHR-1701 + Rivoceranib — DRUG
    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.

Study Details

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

Key Dates

First listed
Dec 31, 2025
Start date
Jan 1, 2026
Status verified
Nov 2025
Primary completion
Jan 1, 2028
Completion
Dec 1, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Progression-free survival (PFS) [ 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. ]

Central Contacts

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