Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer
Conditions
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.
Interventions
DRUGThalidomide+cetuximab+FOLFOX/FOLFIRI
Thalidomide+cetuximab+FOLFOX/FOLFIRI
Sponsors
Chongqing Medical University
Xinqiao Hospital of Chongqing
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ETS | 8 weeks | Early tumor shrinkage |
Secondary
| Measure | Time frame |
|---|---|
| ORR | 8 weeks |
| DCR | 8 weeks |
| PFS | 1 year |
Countries
China
Contacts
Primary ContactJianguo Sun, doctor
Backup Contactrui kong, doctor
Outcome results
None listed