Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer

NCT ID: NCT06184698

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 173 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-03-01

Brief Summary

This is a multi-center, single-arm study to investigate the efficacy and safety of liposomal irinotecan+5-FU/LV+ bevacizumab as second-line therapy in metastatic colorectal cancer in Chinese population.

Detailed Description

Colorectal cancer (CRC) has a poor prognosis and poses a serious threat to human health. FOLFIRI (irinotecan+5-FU/LV) / FOLFOX (oxaliplatin+5-FU/LV) ± angiogenesis inhibitors are common treatments for advanced CRC. For patients receiving oxaliplatin-based therapy, irinotecan-based therapy is recommended as second-line therapy. Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose, improve the efficacy and reduce the toxic side effects. The aim of this study is to explore the efficacy and safety of liposomal irinotecan+5-FU/LV + bevacizumab as second-line treatment for metastatic CRC.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

liposomal irinotecan+5-FU/LV+ bevacizumab q2w

Group Type: EXPERIMENTAL

liposomal irinotecan

Intervention Type: DRUG

liposomal irinotecan 70 mg/m²

5-FU

Intervention Type: DRUG

5-FU 2400 mg/m²

LV

Intervention Type: DRUG

5-FU 2400 mg/m²

Bevacizumab

Intervention Type: DRUG

bevacizumab 5 mg/kg

Interventions

liposomal irinotecan

liposomal irinotecan 70 mg/m²

Intervention Type: DRUG

5-FU

5-FU 2400 mg/m²

Intervention Type: DRUG

LV

5-FU 2400 mg/m²

Intervention Type: DRUG

Bevacizumab

bevacizumab 5 mg/kg

Intervention Type: DRUG

Other Intervention Names

nal-IRI; Fluorouracil; Calcium folinate; Avastin

Eligibility Criteria

Inclusion Criteria

• Age: 18-75 years old.
• Histologically or cytologically proven colon or rectum adenocarcinoma.
• Confirmed as unresectable metastatic disease through radiological examination.
• At least one measurable lesion (according to RECIST v1.1).
• First-line treatment with oxaliplatin-based therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 2.
• The expected survival time ≥3 months.
• Subject has adequate biological parameters as demonstrated by the following: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin (Hgb) ≥90 g/L, white blood cell (WBC)≥3.0×10^9/L.
• Adequate hepatic function as evidenced by total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT) ≤2.5 x ULN, ≤5 x ULN if liver metastases are present.
• Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 x ULN or creatinine clearance ≥60 mL/min, proteinuria <2+.
• Normal coagulation function (INR≤1.5).
• Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.

Exclusion Criteria

• Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.
• Previous treatment with irinotecan/liposomal irinotecan.
• MSI-H/dMMR
• Massive pleural effusion or ascites requiring intervention.
• Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
• Active HIV, HBV, HCV infection.
• Combined with uncontrollable systemic diseases.
• Presence of severe gastrointestinal disease (including active bleeding, > grade 1 obstruction , > grade 1 diarrhea or gastrointestinal perforation)
• History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrolment.
• Presence of interstitial pneumonia or pulmonary fibrosis.
• Allergy to or intolerance to therapeutic drugs or their excipients;.
• History of pulmonary hemorrhage/hemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within one month prior to enrollment.
• Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before enrollment.
• Patients with symptomatic central nervous system metastases.
• Documented serum albumin ≤3 g/dL
• Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
• Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
• Participated in other trial within 30 days prior to the first dose of study treatment.
• Patients who had received any intravenous antineoplastic therapy within 28 days or oral antineoplastic therapy within 14 days before the first dose of study drug
• Patients who are not suitable to participate in this trial for any reason judged by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guiying Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Hebei Medical University Fourth Hospital

Locations

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuhua Hu, Doctor

Role: CONTACT

huxvhua@126.com

0311-86095347

Facility Contacts

Xuhua Hu

Role: primary

wangguiying@hebmu.edu.cn

031186095347

Other Identifiers

CSPC-DEY-CRC-K04

Identifier Type: -

Identifier Source: org_study_id