Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

August 11, 2020 updated by: Fudan University

A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Cetuximab Plus Chemotherapy Versus Chemotherapy Alone for Colorectal Cancer Liver Metastasis With Progression After First-line Treatment of Cetuximab

For patients with unresectable colorectal cancer liver metastases, preclinical studies have shown that after the resistance of cetuximab, the treatment sensitivity can be restored by stopping cetuximab for a period of time. This is called the cetuximab re-challenge. And the circulating tumor DNA (ctDNA) test is reported a biomarker for the efficacy of cetuximab rechallenge. However, there is still no randomized controlled trial for verification. This study aims at patients after the first-line treatment of cetuximab has progressed. After the second-line non-cetuximab treatment has progressed, the effects of re-application of combined with cetuximab and chemotherapy alone are compared to verify the re-challenge effect.

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

Patients with colorectal cancer liver metastases were RAS wild type, received first-line cetuximab plus chemotherapy. After first-line progression, second-line non-cetuximab treatment were used. After second-line progression, ctDNA is test, and patients with RAS wild-type are enrolled in the study to compare cetuximab plus chemotherapy vs. chemotherapy alone as third-line treatment. Treatment will continue until disease progression or unacceptable toxic effects. The primary endpoint is the disease control rate，which will be assessed by local multidisciplinary team with the use of contrast-enhanced CT or MRI after 4 cycles and then every other 4 cycles up to 12 cycles.

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 (Anticipated)

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.
50

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.
  • Phase 3

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

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Primary tumour was histologically confirmed colorectal adenocarcinoma;
  2. Clinical or radiological evidence of non-resectable liver metastases;
  3. With at least one measurable tumor;
  4. Received first-line cetuximab (RAS gene wild type) treatment and progressed
  5. Received second-line non-cetuximab treatment and progressed
  6. Received circulating tumor DNA test and has RAS gene wild type status;
  7. Performance status (ECOG) 0~1
  8. A life expectancy of ≥ 3 months
  9. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
  10. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 5 x ULN(within 1 week prior to randomization);
  11. Written informed consent for participation in the trial.

Exclusion Criteria:

  1. Patients with known hypersensitivity reactions to any of the components of the study treatments.
  2. Acute or sub-acute intestinal occlusion
  3. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
  4. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Known drug abuse/ alcohol abuse
  5. Legal incapacity or limited legal capacity
  6. Pre-existing peripheral neuropathy.

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: Randomized
  • Interventional Model: Parallel 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: Arm A
Using treatment of cetuximab plus chemotherapy. Cetuximab: 500 mg/m2 IV over 2 hours, day 1, every 2 weeks. Chemotherapy: detailed regimen is determined by a multi-disciplinary team.
Drug: Cetuximab
Cetuximab is used for only patients with ctDNA test RAS wild type.
Drug: Chemotherapy
The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.
Active Comparator: Arm B
Using treatment of chemotherapy alone. Chemotherapy: detailed regimen is determined by a multi-disciplinary team
Drug: Chemotherapy
The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.

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
disease control rate
Time Frame: 2 years
According to the RECIST v.1.1, the disease control rate (DCR) is the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD), evaluated by radiology (CT, MRI, etc.).
2 years

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
objective response rate
Time Frame: 2 years
According to the RECIST v.1.1, the disease control rate (DCR) is the proportion of patients with complete response (CR) and partial response (PR), evaluated by radiology (CT, MRI, etc.).
2 years
progression-free survival
Time Frame: 2 years
The period from the first day of treatment to the date of disease progression (PD) or to death.
2 years
overall survival
Time Frame: 2 years
The period from the first day of treatment to the date of death.
2 years

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

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 (Anticipated)

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.
September 1, 2020

Primary Completion (Anticipated)

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.
August 31, 2022

Study Completion (Anticipated)

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.
August 31, 2024

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).
August 10, 2020

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.
August 11, 2020

First Posted (Actual)

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.
August 12, 2020

Study Record Updates

Last Update Posted (Actual)

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.
August 12, 2020

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.
August 11, 2020

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.
August 1, 2020

More Information

Terms related to this study

Keywords

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.
  • Cet-rechallenge

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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