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

NCT ID: NCT07099794

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2029-08-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NALIRI+Lenvatinib

Liposomal irinotecan+5-FU/LV+Lenvatinib

Group Type: EXPERIMENTAL

Liposomal irinotecan+5-FU/LV+Lenvatinib

Intervention Type: 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

Liposomal irinotecan+5-FU/LV

Group Type: EXPERIMENTAL

NALIRI

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Beijing, , China

Countries

China

Central Contacts

Wen Zhang, Doctor

Role: CONTACT

wenwen0605@163.com

+8618611643302

Other Identifiers

NCC EC/IRB

Identifier Type: -

Identifier Source: org_study_id