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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-11

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical

NCT02748772

Colorectal Neoplasms

UNKNOWN PHASE3

Safety of Cetuximab and Trifluridin Tipiracil as the Third-line Therapy in the RASwt mCRC

NCT05155124

Colorectal Neoplasms Malignant

UNKNOWN PHASE1

Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer

NCT00890188

Colon Cancer

UNKNOWN PHASE2

The Effects of Neoadjuvant Tislelizumab Combined With Chemotherapy in Locally Advanced MSS Rectal Cancer

NCT06254521

Rectal Cancer Rectal Cancer Stage II Rectal Cancer Stage III

RECRUITING PHASE2

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer

NCT06024356

Colorectal Neoplasms

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test group

Thalidomide+cetuximab+FOLFOX/FOLFIRI

Group Type EXPERIMENTAL

Thalidomide+cetuximab+FOLFOX/FOLFIRI

Intervention Type DRUG

Thalidomide+cetuximab+FOLFOX/FOLFIRI

control group

cetuximab+FOLFOX/FOLFIRI

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thalidomide+cetuximab+FOLFOX/FOLFIRI

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No