A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT07099794
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Biliary Tract Cancer (BTC)

Eligibility Criteria

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

Interventions

  • Liposomal irinotecan+5-FU/LV+Lenvatinib — DRUG
    Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w Renvastinib: ≥60kg, 12mg; \<60kg, 8mg, PO, once daily 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w
  • NALIRI — DRUG
    Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w

Study Details

This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.

Key Dates

Start date
Aug 1, 2025
Status verified
Jun 2025
Primary completion
Feb 28, 2029
Completion
Aug 31, 2029

Study Design

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

Arms

  • Experimental: NALIRI+Lenvatinib
    Liposomal irinotecan+5-FU/LV+Lenvatinib
  • Experimental: NALIRI
    Liposomal irinotecan+5-FU/LV

Primary Outcome Measure

Progression-free survival [ Time Frame: 5 years ]

Central Contacts

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