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Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer

NCT05009953 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-07-11

No results posted yet for this study

Summary

This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced biliary tract cancer.

Conditions

  • Advanced Biliary Tract Cancer
  • Intrahepatic Cholangiocarcinoma
  • Extrahepatic Cholangiocarcinoma
  • Gallbladder Carcinoma

Interventions

DRUG

Irinotecan Liposome Injection

Irinotecan Liposome Injection, intravenously, over 90 min on days 1 of every 14-day cycle, 43mg/10mL

DRUG

SG001

Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, intravenously, over 60 min on days 1 of every 14-day cycle, 100mg/10mL

DRUG

Fluorouracil

5-Fluorouracil (5-Fu), intravenously, over 46 h on days 1 of every 14-day cycle

DRUG

Leucovorin

Leucovorin (LV), intravenously, over 30 min on days 1 of every 14-day cycle

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiangdong Cheng · Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-01-16
Completion
2023-01-16

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05009953 on ClinicalTrials.gov