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Recruiting

NCT Number: NCT06279351

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, 400037, China

Location status: Recruiting

Location contact

jianguo Sun, Phd

CONTACT

[email protected]

023-68774490

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Thalidomide+cetuximab+FOLFOX/FOLFIRI

Drug

Thalidomide+cetuximab+FOLFOX/FOLFIRI

Primary outcomes

  1. ETS

    Time frame: 8 weeks

    Early tumor shrinkage

Secondary outcomes

  1. ORR

    Time frame: 8 weeks

  2. DCR

    Time frame: 8 weeks

  3. PFS

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Jianguo Sun, doctor

CONTACT

[email protected]

023-68774490

rui kong, doctor

CONTACT

[email protected]

15823688918

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Collaborators

  • Chongqing Medical University

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.