Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer

February 21, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

The goal of this clinical trial is to test in biliary tract cancer patients . The main questions it aims to answer are:

  • To evaluate the efficacy of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer
  • To evaluate the safety of irinotecan liposome injection combined with 5-FU/LV± immunotherapy for first-line gemsitabine + immunoprogressive metastatic biliary tract cancer This study intends to use liposomal irinotecan combined with 5-FU/LV± immunotherapy for second-line treatment of advanced biliary tract cancer that has progressed after gemsitabine + immunotherapy to evaluate the efficacy and safety of this regimen, with a view to providing better treatment options for second-line patients with advanced biliary tract cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Cancer hospital Airport hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of histologically or cytologically confirmed cholangiocarcinoma

Description

Inclusion Criteria:

  1. The patient had good compliance, could understand the research process of the study, and signed a written informed consent;
  2. Age ≥18 years, ≤75 years;
  3. Histologically or cytologically confirmed cholangiocarcinoma;
  4. Documented metastatic disease;
  5. At least one measurable lesion according to RECIST v1.1;
  6. Disease progression after gemcitabine + immunotherapy;
  7. For patients whose disease recurred after curative resection (R0 or R1), previous adjuvant 5-FU-based chemotherapy is allowed if there is at least 6 month-interval between the last dose of adjuvant chemotherapy and recurrence of disease;
  8. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1;
  9. The expected survival time is greater than 3 months;

  10. Having adequate organ function, as defined below:

    1. Absolute neutrophil count (ANC) ≥1.5*109/L
    2. Hemoglobin ≥90g/dL
    3. Platelets (PLT) ≥100*109/L
    4. Total bilirubin < 1.5 times Upper Normal Value (ULN)
    5. Chemical examination of liver function index (AST&ALT) < 2.5 times Upper Limit of Normal (ULN)
    6. Serum creatinine (Cr) ≤1.5×ULN
  11. Non-pregnant or lactating women; Effective contraception should be used by women/men of childbearing age during the study period and for 6 months after the end of study treatment-

Exclusion Criteria:

（1) Serum total bilirubin ≥2 x ULN (upper limit of normal) (biliary obstruction allows biliary drainage); （2）Severe renal impairment (Clcr ≤ 30 ml/min); （3）Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment； （4）Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 2; （5）Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months; （6） NYHA(New York Heart Association) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings; （7） Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's health; （8） Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors； （9） Known hypersensitivity to any of the components of Onivyde other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin; （10）Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use an effective method of contraception, during therapy and for 3 months following the last dose of Onivyde. Females of Childbearing Potential must either agree to use and be able to take effective contraceptive birth control measures (Pearl Index < 1) or agree to practice complete abstinence from heterosexual intercourse during the course of the study and for at least 3 months after last application of program treatment. A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 years, or unless she is surgically sterile. Males must agree not to father a child (including not donating sperm) during the course of the trial and for at least 6 months after last administration of study drugs; （11） Previous treatment with combination drug tegafur, gimeracil, and oteracil potassium with seven days before enrollment; （12） Current treatment with Sorivudine; （13） Severe fatigue or bone marrow depression after prior radiotherapy or antineoplastic therapy; （14）There are serious concomitant diseases, such as diabetes mellitus and can not be well controlled by hypoglycemic drugs, clinically serious (that is, active) heart disease, renal failure, liver failure, uncontrolled epilepsy, central nervous system disease or history of mental disorders, hemorrhagic peptic ulcer, intestinal paralysis, intestinal obstruction, etc.; （15） History of other malignancy with a disease-free interval <5 years (Registration is permitted if it has minimal impact on prognosis, such as carcinoma in situ and papillary thyroid cancer); （16） History or current eveidence of brain metastasis; （17）Patients deemed unsuitable for this trial by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Arms
Drug: Irinotecan Hydrochloride Liposome Injection The recommended dose and regimen of Irinotecan Hydrochloride Liposome Injection is 70 mg/m2 intravenously over 90 minutes, followed by dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 3 weeks.It can be combined or partially combined immunotherapy.
Drug: Irinotecan Hydrochloride Liposome Injection ；Fluorouracil ；Leucovorin；immunotherapy
The recommended dose and regimen of Irinotecan Hydrochloride Liposome Injection is 70 mg/m2 intravenously over 90 minutes, followed by dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 3 weeks.It can be combined or partially combined immunotherapy.
Other Names:
  • Liposomal irinotecan
  • 5-FU/LV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: from the date of enrollment to the earlier of the date of confirmed progression or death from any cause. (assessed up to 12 months
Progression-free survival is the time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.
from the date of enrollment to the earlier of the date of confirmed progression or death from any cause. (assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: from the date of enrollment to death from any cause. (assessed up to 12 months）
Overall survival is the time from the date of enrollment to death from any cause
from the date of enrollment to death from any cause. (assessed up to 12 months）
Response rates determined by the investigator according to the RECIST(Response Evaluation Criteria in Solid Tumors) v1.1
Time Frame: Time Frame: from the date of enrollment to end of treatment. (assessed up to 12 months）
The response rate is the proportion of eligible patients with measurable lesions with a overall response of CR(Complete Response) or PR(Partial Response)
Time Frame: from the date of enrollment to end of treatment. (assessed up to 12 months）
EORTC-QLQ (European Organization for Research and Treatment of Cancer - Quality of life Questionnaire) C30 (version 3.0)
Time Frame: from the date of Screening to end of treatment. (assessed up to 12 months)
EORTC-QLQ C-30 questionnaires will be performed at screening visit, at pre-dose (Cycle 1 Day1) of every subsequent cycle, at the end of treatment visit. It is a 30-item questionnaire. It has 4-point scales for the item number 1 to 28. These are coded with the same response categories as items 1 to 28, namely "not at all=1" "a little=2" "quite a bit=3" and "very much=4" It has 7-point scale for question number 29 to 30. These are coded with the same response categories as items 29 to 30, namely "worst=1" to "best=7" Total score will be minimum 30 and maximum 126.
from the date of Screening to end of treatment. (assessed up to 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 5, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DNY-BTC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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