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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT07464756
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastric Adenocarcinoma

Eligibility Criteria

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

Interventions

  • SHR-1701 — DRUG
    SHR-1701, 1800mg, Q3w
  • apatinib — DRUG
    apatinib 250mg，Q3W
  • S-1 & Oxaliplatin — DRUG
    S-1, Oxaliplatin, Q3w

Study Details

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.

Key Dates

Start date
Apr 5, 2026
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
Jul 31, 2030

Study Design

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

Arms

  • Experimental: SHR-1701, apatinib, and SOX
  • Experimental: SHR-1701 and SOX

Primary Outcome Measure

Pathological Complete Response (pCR) [ Time Frame: Up to 9 weeks after completion of 3 cycles (each cycle is 21 days) of neoadjuvant treatment ]

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