Liposomal Irinotecan Combined with Sintilimab for Second-line Treatment of Progressive Gastric Cancer

Sponsor
Ruijin Hospital
Study ID
NCT06697366
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Evaluating the efficacy and safety of irinotecan liposome injection in combination with Sintilimab in the second-line treatment of progressive gastric cancer

Key Dates

Start date
Nov 20, 2024
Status verified
Nov 2024
Primary completion
May 20, 2026
Completion
Nov 20, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment
    The patients with Progressive Stage Gastric Cancer will be enrolled and given Sintilimab: 200 mg over 1 hour IV, given every 3 weeks. Irinotecan Liposome Injection II: 56.6 mg/m2 (free base) every 3 weeks, depending on the dose. Sequence of administration: Sindilizumab and Irinotecan Liposome Injection II will be given sequentially. Pre-treatment medication: Dexamethasone and antiemetic (or prophylactic irinotecan if preferred according to hospital practice).

Primary Outcome Measure

overall response rate,ORR [ Time Frame: up to two years ]

Central Contacts

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