Clinical Study of Irinotecan Hydrochloride Liposome Combined With Capecitabine for Second-line Treatment in Patients With Advanced or Metastatic Biliary Tract Carcinoma

Sponsor
Ba Yi
Study ID
NCT06430827
Phase
PHASE2
Status
Unknown

Conditions

  • Biliary Tract Carcinoma

Eligibility Criteria

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

Interventions

  • irinotecan hydrochloride liposome injection — DRUG
    rinotecan hydrochloride liposome injection (70mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
  • Capecitabine — DRUG
    Capecitabine (1000 mg/m\^2) will be administered orally in a 2-week treatment cycle, twice a day from day 1 to day 10 of each cycle

Study Details

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

Key Dates

Start date
Jun 30, 2024
Status verified
May 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

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

Arms

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

Primary Outcome Measure

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

Central Contacts

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