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Not yet recruiting NCT07099794

A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen

Phase II Interventional Biliary Tract Cancer (BTC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liposomal irinotecan+5-FU/LV+Lenvatinib, NALIRI.
Who it may be relevant to
Registry conditions: Biliary Tract Cancer (BTC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study

Overview

This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.

Interventions

  • Drug Liposomal irinotecan+5-FU/LV+Lenvatinib
    Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w Renvastinib: ≥60kg, 12mg; \<60kg, 8mg, PO, once daily 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w
  • Drug NALIRI
    Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w

Primary outcome measures

  • Progression-free survival [Time frame: 5 years]
Secondary outcome measures (4)
  • Overall survival [Time frame: 5 years]
  • Objective Response Rate [Time frame: 5 years]
  • Disease control rate [Time frame: 5 years]
  • Adverse events [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • The patients voluntarily joined the study and signed the informed consent;
  • Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;
  • Previous first-line combination therapy failed;
  • At least one measurable lesion meets the RECIST v1.1 criteria
  • ECOG PS：0\~1；
  • Expected survival ≥12 weeks;
  • Essential organ and hematological function;
  • Patients need contraception;

Exclusion criteria

  • The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;
  • Patients had active malignancies other than BTC within 5 years or at the same time.
  • Clinical symptoms or diseases of the heart that are not well controlled;
  • Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
  • Any clinically significant gastrointestinal disorder, including bleeding, inflammation, occlusion, or diarrhea > grade 2;
  • A thrombotic or embolic event occurred within 6 months prior to the start of the study therapy;
  • Use of strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogiaries) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent;
  • Known allergy to the study drug;
  • An uncontrolled infection occurs during screening;
  • Patients with congenital or acquired immune deficiency (e.g., HIV);
  • Have a history of brain metastases or have developed brain metastases;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Uni — Beijing

Identifiers

NCT: NCT07099794 · NCC EC/IRB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗