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

NCT06279351 | Recruiting Phase 2 DMC

• 1 other identifier: Thalicolorectal
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• ETS

  Early tumor shrinkage

  8 weeks

Secondary Outcomes (3)

• ORR

  8 weeks

• DCR

  8 weeks

• PFS

  1 year

Study Arms (2)

Test group

EXPERIMENTAL

Thalidomide+cetuximab+FOLFOX/FOLFIRI

Drug: Thalidomide+cetuximab+FOLFOX/FOLFIRI

control group

NO INTERVENTION

cetuximab+FOLFOX/FOLFIRI

Interventions

Thalidomide+cetuximab+FOLFOX/FOLFIRI DRUG

Thalidomide+cetuximab+FOLFOX/FOLFIRI

Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with severe dysfunction of vital organs (heart, liver, kidney);
• Patients with other malignant tumors;
• Patients who are pregnant or breastfeeding (women of childbearing age need to check pregnancy test);
• In the active phase of acute or chronic infectious diseases;
• People with a clear history of drug allergy or allergic constitution;
• Patients participating in other clinical trials;
• Other conditions in which the patient was considered inappropriate to participate in the study.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead
• Chongqing Medical University: collaborator

Study Sites (1)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

Study Officials

• rui kong, doctor

  Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianguo Sun, doctor

CONTACT

023-68774490; sunjianguo@tmmu.edu.cn

rui kong, doctor

CONTACT

15823688918; kongruiok@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of oncology department, Clinical Professor

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: February 28, 2024
• Study Start: August 11, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)