Phase 3
Completed N=78
Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
Source: ClinicalTrials.gov NCT01164202 ↗Enrolled (actual)
78
Serious AEs
35.1%
Results posted
Mar 2022
Primary outcomePrimary: Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure — 5.88; 2.78 percentage of participants
◆ Published Evidence
Established
20citations · ~4 / year
Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study.
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 of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether chemoembolization is more effective with or without sunitinib malate in treating patients with liver cancer.
PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization of the liver and to see how well in works when given together with or without sunitinib malate in treating patients with liver cancer.
Linked Publications
-
Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure |
5.88; 2.78 | — |
| SECONDARY Overall Survival |
20.5; 25 | — |
| SECONDARY Disease-free Survival |
5.5; 9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01164202) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.