NCT06279351 Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
| NCT ID | NCT06279351 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Xinqiao Hospital of Chongqing |
| Condition | Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-08-11 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 96 participants in total. It began in 2024-08-11 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
rui kong, doctor
PRINCIPAL INVESTIGATOR
Chongqing Medical University
Frequently Asked Questions
Who can join the NCT06279351 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06279351 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06279351 currently recruiting?
Yes, NCT06279351 is actively recruiting participants. Contact the research team at sunjianguo@tmmu.edu.cn for enrollment information.
Where is the NCT06279351 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06279351 clinical trial?
NCT06279351 is sponsored by Xinqiao Hospital of Chongqing. The principal investigator is rui kong, doctor at Chongqing Medical University. The trial plans to enroll 96 participants.
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