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Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma

1 april 2011 bijgewerkt door: China Medical University Hospital

Phase II Study of Combined Sorafenib With Radiotherapy in Patients With Advanced Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC. With the development of new radiotherapy (RT) technique, RT can be more safely given to patients with larger tumor burden. Thus, TACE combined with RT has been suggested for treating large HCC. Based on the results of these studies, RT could achieve a tumor response rate of 50 % to 70 %. However, it has not been definitively shown to prolong the overall or disease-free survival due to lack of a phase III clinical trial. In contrast, a retrospective clinical investigation with molecular study suggests that sublethal dose of RT promoted HCC growth outside RT field.

Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo. It is interesting to recognize the combined therapeutic effect of RT with sorafenib. Based on several preclinical experiments, tumor angiogenesis inhibitors seem to be synergistic with irradiation when using before RT, concurrently with RT, or after RT. Thus, the investigators design a single-arm phase II clinical trial to investigate the efficacy of combined RT with sorafenib.

The eligibility criteria are patients with unresectable HCC; good performance status; no prior radiotherapy for the liver; clinical measurable tumor; good liver function and good compliance. After entering this study, the testee will receive RT to hepatic tumor with concurrently sorafenib with a dose of 400 mg twice daily. Hepatic RT will be performed with a daily fraction size of 2.0 to 2.5 Gy to a total dose of 46 Gy to 60 Gy. After RT, maintenance sorafenib with a dose of 400 mg twice daily will be ongoing. Sorafenib will be continued until the occurrence of clinical or radiologic progression, or the occurrence of either unacceptable adverse events or death. Minimum maintenance duration of 6 months is recommended, but not mandatory.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The primary end points are response rate and toxicities profile. The secondary endpoints are time to disease-free survival, overall survival, and quality of life assessment.

Studietype

Observationeel

Inschrijving (Verwacht)

45

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Taiwan
      • Taichung, Taiwan, 404
        • Werving
        • Shang-Wen Chen
        • Contact:
        • Onderonderzoeker:
          • Yu-Cheng Kuo
        • Onderonderzoeker:
          • Ji-An Liang, MD
      • Tainan, Taiwan, 700
      • Taipei, Taiwan, 100

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar tot 69 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Paitents with unresectable hepatoma with transarterial chemoembolization (TACE) failure or who are not suitable for TACE.

Beschrijving

Inclusion Criteria:

  • Patients with unresectable hepatoma with transarterial embolization (TAE) failure or who are not suitable for TACE. A maximal tumor diameter > 3.0 cm.
  • Age: 20 ~ 69 years.
  • ECOG 0 or 1.
  • Life expectancy of at least 12 weeks.
  • Child-Pugh A or B (preferentially score ≦ 7).
  • Cancer of the Liver Italian Program (CLIP) score ≦ 3.

  • Pretreatment liver function test and renal function test:

    • Total bilirubin < 1.5 times the upper limit of normal (ULN)(≦ 3.0 (ULN) in patients treated by biliary drainage for obstructive jaundice)
    • GOP/GPT ≦ 5 X of upper limit of normal range
    • Alkaline phosphatase ≦ 4X of upper limit of normal range
    • Prothrombin time/partial prothrombin time < 1.5 X of ULN
    • Serum Creatinine ≦ 1.0 x ULN

  • Pretreatment blood count:

    • Hemoglobulin ≧ 9 g/dl
    • Absolute neutrophil count ≧ 1500/mm3
    • Platelet count ≧ 50,000/mm3
  • Subjects with at least one uni-dimensional or bi-dimensional measurable lesion. Lesion must be measured by CT scan or MRI.
  • Patients must fully recover from prior therapy that given > 4 weeks before enrollment.
  • Signed informed consent must be obtained prior to any study related procedures.

Exclusion Criteria:

  1. Child-Pugh C
  2. CLIP score ≧ 4
  3. Patients with evidence of extrahepatic or metastatic disease
  4. Patients with evidence of massive ascites
  5. Patients receiving previous irradiation to liver
  6. Patients with previous use of Thalidomide less than 6 months from entering of the study
  7. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted)
  8. Active clinically serious infections ( > grade 2 CTC version 2)
  9. Patients undergoing renal dialysis
  10. Patients with evidence or history of bleeding diathesis
  11. Prior treatment with EGFR TKIs or VEGFR TKIs
  12. Hypertension uncontrolled by medical therapy
  13. Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper.
  14. Chemotherapy or immunotherapy or other systemic anti-cancer therapy within 4 weeks.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
radiotherapy efficacy
  1. Concurrent stage with RT: sorafenib 400mg twice daily
  2. Maintenance stage after RT: sorafenib 400mg twice daily Treatment can be continued until the occurrence of clinical or radiologic progression, the occurrence of either unacceptable adverse events, death, or any criteria met for removal from the protocol treatment. Basically, minimum maintenance duration of 6 months is recommended, not mandatory.
Straling: sorafenib and radiotherapy for hepatocellular carcinoma
Concurrent and maintenance sorafenib 400mg twice daily
Andere namen:
  • Combined radiotherapy and sorafenib.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Response rate
Tijdsspanne: 6 months
  1. The tumor response rate will be evaluated at the 6th month after the ending of radiotherapy.
  2. The response rate includes complete and partial response according to the RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Disease progression-free survival
Tijdsspanne: 2 years

Disease progression-free survival:

Patients with the evidence of clinical or radiographic progressive disease will be defined as disease progression. The average time period for the follow-up will be two years.
2 years
Overall survival
Tijdsspanne: 2 years
Participants will be followed. The average time period will be two years.
2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

China Medical University Hospital

Onderzoekers

  • Hoofdonderzoeker: Shang-Wen Chen, MD, Department of Radiation Oncology, China Medical University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2010

Primaire voltooiing (Verwacht)

1 juni 2012

Studie voltooiing (Verwacht)

1 december 2012

Studieregistratiedata

Eerst ingediend

20 maart 2011

Eerst ingediend dat voldeed aan de QC-criteria

1 april 2011

Eerst geplaatst (Schatting)

4 april 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

4 april 2011

Laatste update ingediend die voldeed aan QC-criteria

1 april 2011

Laatst geverifieerd

1 maart 2011

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Radiotherapy-Sorafenib

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