Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy

Sponsor
Shandong Tumor Hospital
Study ID
NCT07309185
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stomach Neoplasms

Eligibility Criteria

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

Interventions

  • Adebrelimab — DRUG
    Adebrelimab Injection: 1200mg, i.v.gtt, d1, Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.
  • Irinotecan — DRUG
    Irinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.
  • Malic acid Famitinib — DRUG
    Malic acid Famitinib: 20mg, po, d1-21.

Study Details

This study employs a randomized, controlled, exploratory clinical trial design, with a planned enrollment of 66 patients who have previously failed systemic chemotherapy for recurrent/metastatic gastric cancer,

Key Dates

Start date
Jul 24, 2024
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

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

Arms

  • Experimental: Group 1
    Adebrelimab Injection: 1200mg, i.v.gtt, d1, Malic acid Famitinib: 20mg, po, d1-21. Irinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.
  • Active Comparator: Group 2
    Irinotecan: 125mg/m2, i.v.gtt, d1, 8. Once every 3 weeks, continue medication until disease progression, toxicity intolerance, initiation of new anti-tumor treatment, withdrawal of knowledge, or continuous medication for at least 2 years.

Primary Outcome Measure

PFS [ Time Frame: The longest follow-up period from the patient's enrollment to disease progression or death from any cause is 2 years ]

Central Contacts

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