- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00805896
Songyou Granule and Transarterial Chemoembolization for Hepatocellular Carcinoma
Effectiveness and Safety Study of TACE Plus Oral Songyou Granule for Unresectable HCC
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Primary outcome Measures:
To evaluate the effect of TACE plus Songyou Granule or TACE plus placebo on TTP
Secondary Outcome Measures:
- Overall survival (OS)
- Progression Free Survival (PFS)
- The overall response rate
- Time to symptomatic Progression
- In an exploratory manner the relative TTP, TTSP, RR and overall survival between the 2 study populations
- Overall response duration and time to objective response
- Overall disease control rate
- The safety, tolerability, and adverse event profiles of the two treatment regimens used in this trial
Enrollment: 260 Study Start Date: January 2009 Study Completion Date: December 2010 Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Shanghai
-
Shanghai, Shanghai, Cina, 200032
- Cancer Hospital of Fudan University
-
Shanghai, Shanghai, Cina, 200032
- Liver Cancer Institute and Zhongshan Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Adults patients (≥ 18 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
- Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP > 200
- Patient must have quantifiable disease limited to the liver
Patients must have at least one tumor lesion that meets both of the following criteria:
- The lesion can be accurately measured in at least one dimension according to RECIST criteria
- The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
- ECOG performance status (PS) <2
- No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
- No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A or B
- No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
The following laboratory parameters:
- Platelet count ≥ 50,000/µL
- Hemoglobin ≥ 8.5 g/dL
- Total bilirubin ≤ 2 mg/dL
- ASL and AST ≤ 5 x upper limit of normal
- Serum creatinine ≤ 1.5 x upper limit of normal
- INR ≤ 1.5 or a PTT within normal limits
- Ability to understand the protocol and to agree to and sign a written informed consent document
Exclusion Criteria:
- Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis & T1), and any cancer curatively treated > 3 years prior to entry is permitted
- Renal failure requiring hemo- or peritoneal dialysis
- Child-Pugh C hepatic impairment
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
- Known central nervous system tumors including metastatic brain disease
- History of organ allograft
- Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Patients unable to swallow oral medications.
- Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: 2
|
4g/pack
|
Sperimentale: 1
Songyou Granule
|
4g/pack
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Time to tumor progression(TTP)
Lasso di tempo: Dec 2008 to Dec 2010
|
Dec 2008 to Dec 2010
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Overall survival (OS)
Lasso di tempo: Dec 2008 to Dec 2010
|
Dec 2008 to Dec 2010
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Zhao-You Tang, MD, Fudan University
- Investigatore principale: Boheng Zhang, MD, Fudan University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LCI-1001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .