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A Multicenter Prospective Clinical Trial: Conversion Therapy for RAS/BRAF Wild-Type Right-Sided Colon Cancer Patients With Initially Unresectable Liver Metastases

Conversion Therapy for RAS/BRAF Wild-Type Right-Sided Colon Cancer Patients With Initially Unresectable Liver Metastases

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037711
Enrollment
Unknown
Registered
2020-08-30
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

colorectal cancer

Interventions

FOLFOXIRI plus Cetuximab:FOLFOXIRI plus Cetuximab
FOLFOXIRI plus Bevacizumab:FOLFOXIRI plus Bevacizumab

Sponsors

Fudan University Zhongshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old, = 3 months; 10. Good hematological function: neutrophil >= 1.5 x 10^9/l and platelet count >= 100x10^9 / L; HB >= 9g / dl (within one week before randomization); 11. Normal liver and kidney function: serum bilirubin <= 1.5x normal upper limit (ULN), alkaline phosphatase <= 5x ULN, serum transaminase (AST or ALT) <= 5x ULN (within one week before randomization); 12. Sign the written informed consent to participate in the experiment.

Exclusion criteria

Exclusion criteria: 1. Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy; 2. Known or suspected extrahepatic metastasis; 3. Patients with known hypersensitivity to any component of the study treatment; 4. Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction lower than normal range; 5. Acute or subacute intestinal obstruction; 6. Pregnancy (no pregnancy confirmed by serum / urine ß- hCG) or breastfeeding; 7. Other malignant tumors occurred within 5 years, except those with skin basal cell carcinoma or cervical invasive carcinoma; 8. Known drug / alcohol abuse; 9. No legal capacity or limited legal capacity; 10. There are peripheral neuropathy.

Design outcomes

Primary

MeasureTime frame
conversion-to-resection rate;

Secondary

MeasureTime frame
objective response rate;progress-free survival;overall survival;Incidence of adverse events;

Countries

China

Contacts

Public ContactJianmin Xu

Fudan University Zhongshan Hospital

xujmin@aliyun.com+86 13764353275

Outcome results

None listed

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