DEBIRI Combined With Chemotherapy and Bevacizumab in the Treatment of Unresectable Colorectal Cancer Liver Metastases (DEBIRI)

December 19, 2023 updated by: Xu jianmin, Fudan University

A Prospective, Single-arm Clinical Study on the Efficacy and Safety of DEBIRI Combined With Systemic Chemotherapy and Bevacizumab for Unresectable Colorectal Cancer With Liver Metastases

To study the efficacy and safety of embolization therapy with uniform particle size drug-eluting beads loaded with irinotecan (DEBIRI) in patients with unresectable colorectal cancer liver metastases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Colorectal cancer is the second most common malignant tumor and the fifth cause of cancer death in my country, and its incidence rate is increasing year by year. The liver is the main target organ for hematogenous metastasis of colorectal cancer and the main cause of death in patients with colorectal cancer. About 15% to 25% of patients with colorectal cancer have liver metastases when diagnosed, and another 15% to 25% of patients will develop liver metastases after radical resection of the primary colorectal cancer site. The vast majority (80%) %~90%) of liver metastases cannot be curatively resected initially. The median survival of patients with untreated liver metastases is only 6.9 months, and the 5-year survival rate of patients with unresectable liver metastases is less than 5%. The median survival time of patients who have completely resected liver metastases or reached a state of no evidence of disease is 35 months, and the 5-year survival rate can reach 30% to 57%.

For patients with unresectable colorectal cancer liver metastases, the first-line treatment option recommended by the guidelines is multi-agent chemotherapy with or without targeted therapy.

Currently, there are limited clinical studies on the use of uniform particle size drug-loaded microspheres combined with chemotherapy drugs and targeted drugs to treat unresectable colorectal cancer liver metastases. Based on this, a single-arm, prospective study is planned to be carried out, using conversion resection rate as the main efficacy indicator, to explore the efficacy of embolization therapy with uniform particle size drug-loaded microspheres loaded with irinotecan combined with systemic chemotherapy and bevacizumab versus systemic chemotherapy combined The efficacy and safety of bevacizumab in the treatment of patients with unresectable colorectal cancer liver metastases provide a more reliable basis for clinical treatment in this field.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200032
        • Zhongshan Hospital, Fudan 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1: Age 18-75, no gender limit
  • 2: Colorectal cancer liver metastasis diagnosed by histopathology/imaging or clinically (refer to the "Guidelines for the Diagnosis and Comprehensive Treatment of Colorectal Cancer Liver Metastasis" 2023 Edition)
  • 3: The liver is the main target organ for distant metastasis (defined as ≥80% tumor burden limited to the liver)
  • 4: The liver metastasis is determined to be initially unresectable after discussion by the MDT of the research center
  • 5: There is at least one measurable liver metastasis, and the tumor diameter is >1cm (mRECIST assessment)
  • 6: Liver metastases without interventional treatment (TACE, ablation, iodine particle therapy, etc.)
  • 7: The tumor accounts for less than 60% of the total liver
  • 8: The primary tumor is removed or still exists
  • 9: Have not received anti-tumor treatment in the past or it has been more than 1 year since the last anti-tumor treatment
  • 10: Expected survival >3 months
  • 11: Liver function Child-Pugh class A or B
  • 12: ECOG ≤2 points
  • 13: Adequate renal function (creatinine ≤ 2.0mg/dl)
  • 14: Women of childbearing age and men of childbearing potential voluntarily take appropriate contraceptive measures during treatment
  • 15: Understand and sign the informed consent form

Exclusion Criteria:

  • 1: Combined with other malignant tumors, except for cervical cancer in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled, except for colorectal cancer
  • 2: There are any contraindications to TACE treatment
  • 3: Patients eligible for radical treatment (surgery or ablation)
  • 4: Any contraindications to irinotecan: chronic inflammatory bowel disease and/or intestinal obstruction
  • 5: history of severe allergic reaction to irinotecan hydrochloride trihydrate, lactic acid or lactic acid and mannitol or the excipients in this product
  • 6: Severe bone marrow failure
  • 7: history of Gilbert syndrome (no specific testing required)
  • 8: Those with brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive impairment
  • 9: Severe active infection requiring intravenous antibiotic treatment occurs during the screening period
  • 10: Active bleeding or abnormal coagulation function (PT> 16s, APTT> 43s, INR> 1.5 x ULN), or bleeding tendency or undergoing thrombolytic treatment
  • 11: Patients with serious heart, brain, liver, and kidney system diseases
  • 12: Unstable angina, angioplasty, stent placement or myocardial infarction within 6 months
  • 13: Pregnant or lactating women, and those who are of childbearing potential but refuse to take contraceptive measures
  • 14: Those who are allergic to experimental drugs
  • 15: Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits
  • 16: Those who the researcher believes are not suitable to participate in this trial

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DEBIRI
After dissolving 100 mg of irinotecan in water for injection or 4 ml of 5% glucose water, use 2 mL of 70 μm uniform particle size microspheres for loading and adsorption for 5 minutes. Then mixed with non-plasma contrast agent to embolize the tumor feeding artery.
Combination product: DEBIRI Combined With Chemotherapy and Bevacizumab
After dissolving 100 mg of irinotecan in water for injection or 4ml of 5% glucose water.use 2mL of 70μm uniform particle size microspheres for loading and adsorption for 5minutes. Then mixed with non-plasma contrast agent to embolize the tumor feeding artery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
converted resection rate
Time Frame: 1, 3, 6 months after surgery
Discussed and determined by the MDT of the research center.
1, 3, 6 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Actual R0 resection rate
Time Frame: 1, 3, 6 months after surgery
Postoperative pathological examination.No cancer cells can be found at the resection margin of the postoperative specimen under a microscope. There are no cancer cells remaining either to the naked eye or under a microscope, and the lesion has been completely removed.
1, 3, 6 months after surgery
Progression Free Survival
Time Frame: 1, 3, 6 months after surgery
Time from initiation of treatment to tumor progression or death from any cause, whichever occurs first
1, 3, 6 months after surgery
Recurrence-free survival
Time Frame: 1, 3, 6 months after surgery
Time from date of curative surgery to recurrence or death
1, 3, 6 months after surgery
Adverse events
Time Frame: 1, 3, 6 months after surgery
Adverse medical events that occur to subjects during clinical trials
1, 3, 6 months after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jianmin Jianmin, Ph.D, Fudan University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2023-331R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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