RecruitingPhase 2NCT06279351

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

Sponsor

Xinqiao Hospital of Chongqing

Enrollment

96 participants

Start Date

Aug 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

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 Criteria7

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.

Interventions

DRUGThalidomide+cetuximab+FOLFOX/FOLFIRI

Thalidomide+cetuximab+FOLFOX/FOLFIRI

Locations(1)

the second affiliated hospital of Army medical university

Chongqing, Chongqing Municipality, China

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NCT06279351