Clinical trial · Interventional
Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer
A Double-Blind, Randomized, Phase II/III Study Comparing the Use of Chemoembolization Combined With Sunitinib Against Chemoembolization Combined With a Placebo in Patients With Hepatocellular Carcinoma (SATURNE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| sunitinib malate | Drug | Sunitinib | ALIAS |
| transarterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- placebo 3cps/days 4 weeks over 6 during 1 year
- interventionNames
- Drug: Placebo
- Procedure: transarterial chemoembolization
- type
- EXPERIMENTAL
- label
- Sunitinib
- description
- sunitinib (SUTENT®) 37,5 mg/d (3 cps of 12,5 mg) orally 4 weeks over 6 (4 weeks of treatment followed by 2 weeks without treatment) during 1 year
- interventionNames
- Drug: sunitinib malate
- Procedure: transarterial chemoembolization
Primary outcomes (1)
- measure
- Percentage of Patients With Occurrence of Severe Bleeding and/or Liver Failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTTurpin A, de Baere T, Heurgue A, Le Malicot K, Ollivier-Hourmand I, Lecomte T, Perrier H, Vergniol J, Sefrioui D, Rinaldi Y, Edeline J, Jouve JL, Silvain C, Becouarn Y, Dauvois B, Baconnier M, Debette-Gratien M, Deplanque G, Dharancy S, Lepage C, Hebbar M; PRODIGE 16 investigators Collaborators. Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study. Clin Res Hepatol Gastroenterol. 2021 Mar;45(2):101464. doi: 10.1016/j.clinre.2020.05.012. Epub 2020 Jun 21. PMID 32576496