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Efficacy and safety of cetuximab plus FOLFIRI/FOLFOX combined with thalidomide in first-line treatment of RAS and BRAF wild-type stage IV left colorectal cancer

Efficacy and safety of cetuximab plus FOLFIRI/FOLFOX combined with thalidomide in first-line treatment of RAS and BRAF wild-type stage IV left colorectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070448
Enrollment
Unknown
Registered
2023-04-12
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

left colorectal cancer

Interventions

Experimental group:cetuximab plus FOLFIRI/FOLFOX combined with thalidomide

Sponsors

The Third Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion 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; 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

Exclusion criteria: 1. Patients with severe dysfunction of vital organs (heart); 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. Patients 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

MeasureTime frame
Objective response rate, ORR;

Secondary

MeasureTime frame
Adverse reaction;Early tumor regression, ETS;Disease control rate, DCR;Progressive free survival, PFS;Overall survival, OS;Duration of response, DOR;

Countries

China

Contacts

Public ContactKong Rui

the Third Affiliated Hospital of Chongqing Medical University

kongruiok@163.com+86 15823688918

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026