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Effectiveness and Safety Study of TACE Plus Oral Songyou Granule for Unresectable HCC

Phase 2
18 Years
75 Years
Open (Enrolling)
Hepatocellular Carcinoma, Unresectable

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Trial Information

Effectiveness and Safety Study of TACE Plus Oral Songyou Granule for Unresectable HCC

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

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

- 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

- 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

- No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to tumor progression(TTP)

Outcome Time Frame:

Dec 2008 to Dec 2010

Safety Issue:


Principal Investigator

Zhao-You Tang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fudan University


China: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Unresectable
  • Carcinoma
  • Carcinoma, Hepatocellular