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RECRUITINGPHASE2

Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer

Phase II Study of Irinotecan Liposomes Combined With 5-FU/LV+ Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer

NCT06341296•West China Hospital

View on ClinicalTrials.gov

Summary

To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.

Detailed Description

This is a Phase II clinical study to evaluate the efficacy and safety of the combination regimen of irinotecan liposome injection in the first-line treatment of metastatic colorectal cancer. Patients will receive liposomal injections of irinotecan 70mg/m\^2 d1, bevacizumab 5mg/kg d1, LV 400mg/m\^2 d1, 5-FU 400mg/m\^2, then 2400mg/m\^2, continuous intravenous infusion for 46-48h, d1-2. 86 eligible patients will be enrolled.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18\~85 years old.
•Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma.
•RAS/BRAF v600e mutant or right half colon cancer is known.
•pMMR/MSS is known.
•The unresectable stage of metastatic disease has not received any systemic antitumor therapy.
•For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 6 months removed from the date of last administration of neoadjuvant or adjuvant therapy.
•ECOG 0\~1, patients ≥75 years old need an ECOG score of 0
•The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria.
•Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10\^9/L, platelets (PLT) ≥100×10\^9/L, hemoglobin (Hb) ≥80g/L, albumin (ALB) ≥30 g/L, white blood cells (WBC) ≥3.0×10\^9/L, and no bleeding tendency; ② AST, ALT and alkaline phosphatase (ALP) were all ≤2.5× upper limit of normal range (ULN), and ≤5×ULN when liver metastases occurred; The total bilirubin level doesn't exceed the upper limit of the agency's normal range; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40 ml/min (calculated according to Cockroft-Gault)
•Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form.

Exclusion Criteria

•Known or suspected central nervous system metastasis.
•Received irinotecan/irinotecan liposomes/bevacizumab before enrollment.
•Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment.
•Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 I or below(except hair loss and peripheral neuropathy).
•The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment.
•Severe gastrointestinal dysfunction, gastrointestinal perforation, intraperitoneal abscess, and fistula.
•Intestinal obstruction, signs and symptoms of intestinal obstruction, or the stent has been previously implanted and the stent has not been removed before the screening period.
•Interstitial lung disease.
•Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding).
•Patients with fluid accumulation that couldn't reach a stable state but small amount of ascites on imaging without clinical symptoms could be enrolled.
+4 more criteria

Locations (1)

West China Hospital，Sichuan University

Sichuan, Sichuan, Chengdu, China

Key Dates

Start Date

June 30, 2024

Primary Completion Date

April 1, 2026

Completion Date

December 1, 2026

Last Updated

August 12, 2024

Enrollment

ESTIMATED participants

Conditions

Metastatic Colorectal Cancer

Interventions

Irinotecan Liposome

DRUG

5-FU

DRUG

Bevacizumab

DRUG

Contacts

Meng Qiu, MD

CONTACT

028-85423203 qiumeng33@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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