A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT06925516
Phase
PHASE2
Status
Recruiting
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Conditions

  • Intrahepatic Cholangiocarcinoma (Icc)

Eligibility Criteria

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

Interventions

  • Apatinib and Adebrelimab in Combination With chemotherapy — DRUG
    Patients would receive Adebrelimab (IV 1200mg q3w) and apatinib (PO 250mg qd) plus GEMOX (up to 6 cycles) in 21day cycles. Apatinib and Adebrelimab would be maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.

Study Details

The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)

Key Dates

Start date
Apr 25, 2025
Status verified
Nov 2025
Primary completion
Jun 1, 2027
Completion
Oct 1, 2028

Study Design

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

Arms

  • Experimental: Apatinib and Adebrelimab in Combination With chemotherapy
    Adebrelimab (IV 1200mg q3w) and apatinib (PO 250mg qd) plus GEMOX (up to 6 cycles) in 21day cycles

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: 12 months ]

Central Contacts

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