Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer

February 26, 2024 updated by: Jianguo Sun, Xinqiao Hospital of Chongqing
  1. To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.
  2. To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

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 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with RAS and BRAF wild-type IV unresectable left colorectal cancer confirmed by pathology and tissue/cytology and genetic testing;
  2. Physical state is good: PS 0-2;
  3. Expected survival of more than 3 months;
  4. Aged 18-75 years old;
  5. Have not received systematic chemotherapy before;
  6. Did not receive cetuximab treatment;
  7. Liver, kidney and bone marrow functions are basically normal;
  8. The clearance period of chemotherapy and molecular targeted therapy is more than 4 weeks;
  9. Voluntary participation in the group, good compliance, can cooperate with the experiment observation, and sign the written informed consent.

Exclusion Criteria:

  1. Patients with severe dysfunction of vital organs (heart, liver, kidney);
  2. Patients with other malignant tumors;
  3. Patients who are pregnant or breastfeeding (women of childbearing age need to check pregnancy test);
  4. In the active phase of acute or chronic infectious diseases;
  5. People with a clear history of drug allergy or allergic constitution;
  6. Patients participating in other clinical trials;
  7. Other conditions in which the patient was considered inappropriate to participate in the 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
Thalidomide+cetuximab+FOLFOX/FOLFIRI
Drug: Thalidomide+cetuximab+FOLFOX/FOLFIRI
Thalidomide+cetuximab+FOLFOX/FOLFIRI
No Intervention: control group
cetuximab+FOLFOX/FOLFIRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ETS
Time Frame: 8 weeks
Early tumor shrinkage
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: 1 year
1 year
ORR
Time Frame: 8 weeks
8 weeks
DCR
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Xinqiao Hospital of Chongqing

Collaborators

Chongqing Medical University

Investigators

  • Principal Investigator: rui kong, doctor, Chongqing Medical 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)

April 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thalicolorectal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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