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

NCT06463548 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-06-18

No results posted yet for this study

Summary

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.

Conditions

  • Biliary Tract Carcinoma

Interventions

DRUG

irinotecan hydrochloride liposome injection

Irinotecan hydrochloride liposome injection (70mg/m2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.

DRUG

Capecitabine

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.

DRUG

Lenvatinib

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

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY
  • Yunpeng Liu

    lead OTHER

Principal Investigators

  • Xiujuan Qu · First Hospital of China Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06463548 on ClinicalTrials.gov