Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ± Lenvatinib As First-line Treatment for Advanced ICC

Sponsor
Harbin Medical University
Study ID
NCT06648525
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Intrahepatic Cholangiocarcinoma (Icc)

Eligibility Criteria

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

Interventions

  • Adebrelimab — DRUG
    Adebrelimab, IV
  • Irinotecan liposomes — DRUG
    Irinotecan liposomes, IV
  • Lenvatinib — DRUG
    Lenvatinib, po
  • 5-Fluorouracil (5-FU) — DRUG
    5-Fluorouracil (5-FU), IV
  • Calcium Folinate — DRUG
    Calcium folinate, IV

Study Details

This is a multicenter, open label, randomized, two-arm clinical study to observe and evaluate the efficacy and safety of adebrelimab combined with irinotecan liposomes, 5-fluorouracil, calcium folinate ± lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma (ICC).

Key Dates

Start date
Oct 31, 2024
Status verified
Sep 2024
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

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

Arms

  • Experimental: Group A: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib
    Adebrelimab in combination with Irinotecan liposomes, 5-fluorouracil, calcium folinate and lenvatinib
  • Experimental: Group B: Adebrelimab+Irinotecan liposomes+5-fluorouracil+calcium folinate
    Adebrelimab in combination with Irinotecan liposomes, 5-fluorouracil and calcium folinate

Primary Outcome Measure

Progression-Free-Survival (PFS) [ Time Frame: up to 24 months ]

Central Contacts

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