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

August 8, 2024 updated by: Meng Qiu, West China Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan, Chengdu
      • Sichuan, Sichuan, Chengdu, China, 610000
        • Recruiting
        • West China Hospital,Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc.
  • Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer.
  • Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding.
  • The researchers didn't consider it appropriate to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: irinotecan liposome injection combined with 5-FU/LV+ bevacizumab
Patients will be treated with irinotecan liposome injection combined with 5-FU/LV+ bevacizumab. Treatment lasted 8 cycles.
Drug: Irinotecan Liposome
70 mg/m^2 , d1, 14 days per cycle, 8 cycles.
Drug: 5-FU
5-FU 400mg/m^2, then 2400mg/m^2, continuous intravenous infusion for 46-48h, d1-2, 14 days per cycle, 8 cycles.
Drug: LV
400mg/m^2, d1, 14 days per cycle, 8 cycles.
Drug: Bevacizumab
5mg/kg, d1, 14 days per cycle, 8 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first . Assessed up to 4 months
To investigate antitumor efficacy of study.
From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first . Assessed up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first. Assessed up to 4 months
To investigate antitumor efficacy of study.
From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first. Assessed up to 4 months
Progression free survival
Time Frame: From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 30 months.
To investigate antitumor efficacy of study.
From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 30 months.
Overall survival
Time Frame: From initial medication to the date of death from any cause. Assessed up to 30 months.
To investigate antitumor efficacy of study.
From initial medication to the date of death from any cause. Assessed up to 30 months.
Percentage of patients undergoing surgery.
Time Frame: From the first dose to completed 8 cycles treatment. Assessed up to 5 months.
To assess surgical conversion rates in patients who could be surgically resected.
From the first dose to completed 8 cycles treatment. Assessed up to 5 months.
R0 resection
Time Frame: From the first dose to the surgery. Assessed up to 6 months.
To assess surgical conversion rates in patients who could be surgically resected.
From the first dose to the surgery. Assessed up to 6 months.
Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0
Time Frame: From the first dose to completed 8 cycles treatment. Assessed up to 5 months.
To assess the incidence and severity of adverse events in combination regimens.
From the first dose to completed 8 cycles treatment. Assessed up to 5 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-DEY-CRC-K07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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