- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01131689
Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma
Phase 1 Trial of S-1 in Combination With Sorafenib for Patients With Advanced Hepatocellular Carcinoma
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
-
Seoul, Korea, Republiken av
- Samsung Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients with histologically confirmed hepatocellular carcinoma (HCC) or a combination of radiologically compatible finding to HCC, alpha-fetoprotein>400ng/mL and liver cirrhosis
Inoperable disease as defined by
- Localized disease in a portion of the liver that doses not allow the possibility of complete surgical removal of the tumor with a clear resection margin OR
- Presence of extra-hepatic disease OR
- Main portal vein or hepatic vein involvement (invasion or tumor thrombus) OR
- The HCC must not be amenable to intra-arterial therapy or local ablative therapy
- Minimum life expectancy of 12 weeks
- Age>18 years.
- ECOG Performance Status of 0-1
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Hemoglobin>9.0 g/dl
- Absolute neutrophil count (ANC) >1,500/mm3
- Platelet count > 75,000/μl
- Total bilirubin < 1.5 times the upper limit of normal
- ALT and AST <5 x upper limit of normal
- Albumin >= 3g/dL
- PT-INR/PTT <1.5 x upper limit of normal
- Serum creatinine < 1.5 x upper limit of normal or Creatinine clearance >=50mL/min
- Signed and dated informed consent before the start of specific protocol procedures.
Exclusion Criteria:
- Decompensated cirrhosis or stage C according to the Child-Pugh Classification
- Chemo-embolization within 8 weeks of inclusion
- Other concomitant anticancer agent, including Tamoxifen and Interferon
- History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
- History of HIV infection
- Active clinically serious infections (> grade 2 CTCAE version 3.0)
- Symptomatic metastatic brain or meningeal tumors
- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- History of organ allograft
- Patients with evidence or history of bleeding diathesis
- Patients undergoing renal dialysis
- Radiotherapy during study or within 4 weeks of start of study drug.
- Major surgery within 4 weeks of start of study
- Autologous bone marrow transplant or stem cell rescue within 4 months of study
- Prior exposure to the study drug.
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial (and men for at least 3 months after last administration of study medication).
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- Patients unable to swallow oral medications.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
MTD
Tidsram: 1 year
|
Primary objectives: 1. To determine maximal tolerated dose (MTD) of S-1 combined with fixed dose of sorafenib 400mg twice daily. Secondary objectives: 1. To evaluate toxicity profiles and dose-limiting toxicity (DLT) |
1 year
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Adenocarcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i matsmältningssystemet
- Leversjukdomar
- Neoplasmer i levern
- Carcinom
- Karcinom, hepatocellulärt
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Proteinkinashämmare
- Sorafenib
Andra studie-ID-nummer
- 2008-10-009
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Hepatocellulärt karcinom
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, inte rekryterandeOral Cavity Carcinom | Oral intraepitelial neoplasiFörenta staterna
-
Endo PharmaceuticalsAvslutad
-
Indira Gandhi Medical College, ShimlaOkänd
-
Ontario Clinical Oncology Group (OCOG)Avslutad
-
Yueyong XiaoOkänd
-
Michigan State UniversityAvslutad
-
Washington University School of MedicineAvslutad
-
Stanford UniversityAvslutad
-
BayerAmgenAvslutadCarcinomFörenta staterna
Kliniska prövningar på sorafenib, TS-1
-
National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalAvslutad
-
Taiho Pharmaceutical Co., Ltd.Avslutad
-
Taisho Pharmaceutical Co., Ltd.Avslutad
-
Taisho Pharmaceutical Co., Ltd.Avslutad
-
Cancer Institute and Hospital, Chinese Academy...AvslutadNeoplasmer i magen | Kemoterapi | Neoadjuvant terapi | KemoradioterapiKina
-
Chonnam National University HospitalAvslutad
-
Samsung Medical CenterAvslutad
-
Peking UniversityTaiho Pharmaceutical Co., Ltd.Okänd
-
Min-Hee RyuAvslutadMagcancerKorea, Republiken av
-
Taisho Pharmaceutical R&D Inc.AvslutadFriska volontärerFörenta staterna