Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer

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

Exploratory Study of Irinotecan Liposomes Combined With Bevacizumab in Maintenance Therapy of Metastatic Colorectal Cancer

To evaluate the progression-free survival (PFS1), objective response rate (ORR), disease control rate (DCR), progression-free survival from first-line treatment initiation (PFS2), overall survival (OS), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • Phase 1

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

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.
  • pMMR or MSS.
  • CR, PR, or SD (according to RECIST v1.1 criteria) achieved after 12-16 weeks of intensive treatment with a first-line chemotherapy regimen containing irinotecan/fluorouracil or a three-drug chemotherapy regimen containing oxaliplatin/irinotecan/fluorouracil plus bevacizumab.
  • If previously received neoadjuvant or adjuvant therapy, the time interval between initiation of systemic first-line therapy and the date of last dosing must be at least 6 months.
  • ECOG 0~1, patients ≥75 years old need an ECOG score of 0.
  • Normal bone marrow and organ function: ① Neutrophils (ANC) ≥1.5×10^9/L, platelets (PLT) ≥75×10^9/L, hemoglobin (Hb) ≥85g/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 ≥60 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.
  • Had received surgery or other treatment for tumors other than intensive treatment (including chemotherapy, radiotherapy, research treatment, etc., within 4 weeks prior to enrollment, if the interval between the current treatment was longer than 5 drug half-lives, could be included).
  • Previous treatment-related toxicity did not return to NCI-CTCAE v5.0 I or below (except for alopecia, 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.
  • The presence of severe gastrointestinal dysfunction or 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 bevacizumab
Patients will be treated with irinotecan liposome injection combined with bevacizumab. Treatment until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).
Drug: Irinotecan Liposome
70 mg/m^2 , d1, 14 days per cycle. Until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).
Drug: Bevacizumab
5mg/kg, d1, 14 days per cycle. Until the disease progresses, intolerable toxicity occurs, and the patient withdraws informed consent (whichever comes first).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival -1
Time Frame: From initial medication to the date of first documented progression or end of medication, whichever came first . Assessed up to 18 months.
The time from initiation of maintenance therapy to first recording of PD or death, whichever occurs first. 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 18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival -2
Time Frame: The time from the start of first-line treatment to the maintenance of PD treatment or death, whichever occurs first. Assessed up to 24 months.
The time from the start of first-line treatment to the maintenance of PD treatment or death, whichever occurs first. To investigate antitumor efficacy of study.
The time from the start of first-line treatment to the maintenance of PD treatment or death, whichever occurs first. Assessed up to 24 months.
Objective response rate
Time Frame: From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 18 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 18 months
Disease control rate
Time Frame: From initial medication to the date of first documented progression or end of medication , assessed up to 18 months.
To investigate the preliminary antitumor efficacy of study.
From initial medication to the date of first documented progression or end of medication , assessed up to 18 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.
Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0
Time Frame: Assessed up to 6 months.
To assess the incidence and severity of adverse events in combination regimens.
Assessed up to 6 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 (Estimated)

August 9, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

August 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 9, 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-K09

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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