Thalidomide improves cetuximab and chemotherapy effectiveness for left colorectal cancer
Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
This study is testing if adding thalidomide can make cetuximab and chemotherapy work better for people with advanced left colorectal cancer that can't be surgically removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xinqiao Hospital of Chongqing Academic / other |
| Drugs / interventions | cetuximab, chemotherapy |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06279351 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if thalidomide can enhance the effectiveness of cetuximab when combined with standard chemotherapy for patients with stage IV RAS and BRAF wild-type unresectable left colorectal cancer. The trial will evaluate changes in cytokines and their potential impact on the efficacy of the treatment regimen. By assessing these factors, the study seeks to provide a foundation for future research and clinical applications in targeted therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with stage IV unresectable left colorectal cancer who have not previously received chemotherapy or cetuximab.
Not a fit: Patients with severe organ dysfunction, other malignancies, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could significantly improve outcomes for patients with advanced left colorectal cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing treatment efficacy for colorectal cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chongqing, Chongqing Municipality
- the second affiliated hospital of Army medical university — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Principal investigator: rui kong, doctor — Chongqing Medical University
- Study coordinator: Jianguo Sun, doctor
- Email: sunjianguo@tmmu.edu.cn
- Phone: 023-68774490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.