Irinotecan Hydrochloride Liposome Combined With Capecitabine and Lenvatinib in Patients With Biliary Tract Carcinoma

Sponsor
Yunpeng Liu
Study ID
NCT06463548
Status
Not Yet Recruiting

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Conditions

  • Biliary Tract Carcinoma

Eligibility Criteria

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

Interventions

  • irinotecan hydrochloride liposome injection — DRUG
    Irinotecan hydrochloride liposome injection (70mg/m2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
  • Capecitabine — DRUG
    Capecitabine (850 mg/m2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle.
  • Lenvatinib — DRUG
    Lenvatinib (8 mg) will be administered orally in a 2-week treatment cycle, once a day from day 1 to day 14 of each cycle

Study Details

To evaluate the efficacy and safety of irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib for second-line treatment in Patients With advanced or metastatic biliary tract carcinoma.

Key Dates

Start date
Jul 1, 2024
Status verified
Jun 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib
    Patients will receive irinotecan hydrochloride liposome injection combined with Capecitabine and Lenvatinib therapy in a 2-week treatment cycle.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: baseline up to approximately 6 month ]

Central Contacts

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