Status:
COMPLETED
Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Liver Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping anticancer drugs near the tumor. Sunitinib malate may stop the growth of tumor cells by blocking some...
Detailed Description
OBJECTIVES: Primary * To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in patients with unresectable hepatocellular carcinoma treated with transarterial chemoembolizat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed hepatocellular carcinoma or liver tumor responding to the Barcelona criteria
- Child-Pugh score of 5-6 (Class A)
- Tumor suitable for transarterial chemoembolization (one or more planned courses allowed)
- Tumor not suitable for surgical resection
- No extrahepatic metastases, including cerebral metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1.5 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Hemoglobin ≥ 10 g/dL
- PT ≥ 50%
- Creatinine ≤ 120 μmol/L
- Bilirubin normal
- ALT/AST ≤ 3.5 times upper limit of normal (ULN)
- Alkaline phosphatases ≤ 4 times ULN
- Fibrinogen ≥ 1.5 g/L
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No portal vein thrombosis
- Able to comply with scheduled follow-up and management of toxicity
- No uncontrolled hypertension or requiring ≥ 2 classes of antihypertensive drugs
- No concomitant disease or uncontrolled severe disease
- No contraindications to the vascular occlusion procedure
- No prior or concurrent malignancy within the past 5 years, except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell carcinoma of the skin
- No psychiatric disability or social, family, or geographic reason for which the patient may not be followed regularly
- PRIOR CONCURRENT THERAPY:
- At least 7 days since prior CYP3A4 inhibitors or inducers
- At least 3 months since prior radiofrequency ablation
- No prior chemotherapy
- No prior sunitinib, sorafenib, or any other inhibitors of angiogenesis
- No concurrent participation in another trial
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01164202
Start Date
July 1 2010
End Date
July 1 2017
Last Update
March 18 2022
Active Locations (31)
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1
CHU Nord
Amiens, France
2
CHR
Annecy, France
3
Institut Sainte Catherine
Avignon, France
4
CHU J Minjoz
Besançon, France