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

Army Medical University of People's Liberation Army

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Thalidomide+cetuximab+FOLFOX/FOLFIRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06279351

Thalicolorectal

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Test group

Experimental group

Description:

Thalidomide+cetuximab+FOLFOX/FOLFIRI

Treatment:

Drug: Thalidomide+cetuximab+FOLFOX/FOLFIRI

control group

No Intervention group

Description:

cetuximab+FOLFOX/FOLFIRI