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Hepatocellular CarcinomaPhase 2NCT00805896

Songyou Granule and Transarterial Chemoembolization for Hepatocellular Carcinoma

A Phase 2 study testing Songyou in people with Hepatocellular Carcinoma and Unresectable, run by Fudan University at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Songyou Granule is a mixture of 6 herbs. Vitro and vivo studies showed that Songyou Granule can inhibit HCC cells grow, and HCC metastasis. Hypothesis of this study is that TACE plus Songyou Granule will improve outcome in patients with advanced hepatocellular carcinoma (HCC) compared with TACE. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma, Unresectable
What is being tested?
Songyou
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
260 participants
Where
2 sitesChina
Study dates
Dec 2008to Dec 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Cancer Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Liver Cancer Institute and Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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

Songyou Granule is a mixture of 6 herbs. Vitro and vivo studies showed that Songyou Granule can inhibit HCC cells grow, and HCC metastasis. Hypothesis of this study is that TACE plus Songyou Granule will improve outcome in patients with advanced hepatocellular carcinoma (HCC) compared with TACE.

Read the detailed description

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)

Being tested
Songyou, placebo
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SongyouDrug

    4g/pack

  • placeboDrug

    4g/pack

Study groups in NCT00805896
Study groupRoleWhat they receive
1ExperimentalSongyou Granule
Receives: Drug: Songyou
2Placebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to tumor progression(TTP)

    Measured: Dec 2008 to Dec 2010

Secondary outcomes (1)

  1. Overall survival (OS)

    Measured: Dec 2008 to Dec 2010

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2010 (estimated)
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00805896
Sponsor's protocol ID
LCI-1001
Status last verified
Dec 2008
First submitted
9 Dec 2008
Last updated
31 Dec 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Songyou in people with Hepatocellular Carcinoma and Unresectable, run by Fudan University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to tumor progression(TTP) (time frame: Dec 2008 to Dec 2010). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00805896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2008.

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