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

NCT07099794 | Not Yet Recruiting Phase 2

• 1 other identifier: NCC EC/IRB
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biliary Tract Cancer (BTC)

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The time between participant randomization and first recorded disease progression or death from any cause, whichever occurs first.

  5 years

Secondary Outcomes (4)

• Overall survival

  5 years

• Objective Response Rate

  5 years

• Disease control rate

  5 years

• Adverse events

  5 years

Study Arms (2)

NALIRI+Lenvatinib

EXPERIMENTAL

Liposomal irinotecan+5-FU/LV+Lenvatinib

Drug: Liposomal irinotecan+5-FU/LV+Lenvatinib

NALIRI

EXPERIMENTAL

Liposomal irinotecan+5-FU/LV

Drug: NALIRI

Interventions

Liposomal irinotecan+5-FU/LV+Lenvatinib DRUG

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

NALIRI+Lenvatinib

NALIRI DRUG

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

NALIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Wen Zhang, Doctor

CONTACT

+8618611643302; wenwen0605@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)