Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer (SATURNE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01164202
Recruitment Status : Active, not recruiting
First Posted : July 16, 2010
Last Update Posted : December 28, 2016
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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 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.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: sunitinib malate Drug: Placebo Procedure: transarterial chemoembolization Phase 2 Phase 3

Detailed Description:



  • To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in patients with unresectable hepatocellular carcinoma treated with transarterial chemoembolization in combination with sunitinib malate versus transarterial chemoembolization alone.
  • To evaluate the overall survival of these patients.


  • To evaluate the tumor stabilization rate in these patients.
  • To evaluate the safety of this regimen in these patients.
  • To evaluate the disease-free survival of these patients.
  • To evaluate the relapse-free survival of these patients.
  • To evaluate the quality of life of these patients.
  • To evaluate the overall survival rate at 2 years of these patients.

OUTLINE: This is a multicenter study.

Pilot: Patients receive oral sunitinib malate once daily on days 1-28. Beginning 7-10 days later, patients undergo 1-3 courses of transarterial chemoembolization (TACE). Treatment repeats every 6 weeks for 1 year.

Randomization: Patients are stratified according to main tumor diameter (< 5 cm vs ≥ 5 cm), nodular involvement (uninodular vs multinodular), and center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive sunitinib malate and TACE as in the pilot phase.
  • Arm II: Patients receive oral placebo once daily on days 1-28 and TACE as in the pilot phase.

Quality of life is assessed periodically.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : July 2010
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
placebo 3cps/days 4 weeks over 6 during 1 year
Drug: Placebo
placebo 3cps/days 4 weeks over 6 during 1 year
Procedure: transarterial chemoembolization
Experimental: Sunitinib
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
Drug: sunitinib malate
placebo 3cps/days 4 weeks over 6 during 1 year
Procedure: transarterial chemoembolization

Primary Outcome Measures :
  1. Occurrence of severe bleeding or liver failure [ Time Frame: during the week following each TACE ]
  2. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Toxicities [ Time Frame: From Inclusion ]
  2. Disease-free survival [ Time Frame: From Inclusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01164202

CHU Nord
Amiens, France
Annecy, France
Institut Sainte Catherine
Avignon, France
CHU J Minjoz
Besancon, France
Bezier, France
Institut Bergonié
Bordeaux, France
CHU Côte de Nacre
Caen, France
Clermont Ferrand, France
Clinique des Cèdres
Cornebarrieu, France
CHU Bocage
Dijon, France
Guilherand Granges, France
Hôpital Claude Huriez
Lille, France, 59037
Hopital Dupuytren
Limoges, France
Lorient, France
Hôpital Privé Jean Mermoz
Lyon, France
CH Ambroise Paré
Marseille, France
CH Conception
Marseille, France
CHU La Timone
Marseille, France
Hôpital Saint Joseph
Marseille, France
CHRU Saint Eloi
Montpellier, France
CHU -Hôpital de l'Archet II
Nice, France
Orléans, France
Hopital Tenon
Paris, France, 75970
Groupe Hospitalier Paris St Joseph
Paris, France
Hôpital Européen Georges Pompidou
Paris, France
CHU Jean Bernard
Poitiers, France
CHU Robert Debré
Reims, France
Rennes, France
Rouen, France
Tours, France
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Principal Investigator: Mohamed Hebbar, MD Centre Hospital Universitaire Hop Huriez

Additional Information:
Responsible Party: Federation Francophone de Cancerologie Digestive Identifier: NCT01164202     History of Changes
Other Study ID Numbers: PRODIGE 16
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016

Keywords provided by Federation Francophone de Cancerologie Digestive:
adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer
advanced adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors