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A Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Phase III Clinical Trial to Evaluate the Safety and Efficacy of Injectable Tyroserleutide to Treat Hepatocellular Carcinoma


Phase 3
18 Years
75 Years
Open (Enrolling by invite only)
Both
Hepatocellular,Carcinoma

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Trial Information

A Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Phase III Clinical Trial to Evaluate the Safety and Efficacy of Injectable Tyroserleutide to Treat Hepatocellular Carcinoma


- Subjects will return to the hospital 25±5 days after the resection of hepatocellular
carcinoma following the baseline examination. Baseline imaging data will be sent to the
lead study site imaging center for review and verification. The investigator will
determine whether the subject satisfies all inclusion/exclusion criteria. If all
requirements are satisfied, then randomization will occur 25±5 days after surgery

- The day of randomization will be defined as Day 0. Randomized subjects will return to
the hospital and begin cycle 1 on the day of randomization (Day 0). The Investigator
will administer chemotherapy according to the subject's condition. On the next day,
experimental drug therapy will begin, and the relevant laboratory tests will be
performed within 3 days after the end the study drug infusion.

- Cycles will occur every four weeks for the first 6 cycles (i.e. cycles 2, 3, 4, 5, and
6 will begin on days 28 ± 3, 56 ± 3, 84 ± 3, 112 ± 3, and 140 ± 3, respectively). The
second 6 cycles will occur every eight weeks (i.e. cycles 7, 8, 9, 10, and 11, will
begin on days 196 ± 3, 252 ± 3, 308 ± 3, 364 ± 3, and 420 ± 3, respectively).

- the participant will receive medical inspection so as to observe and ensure drug
safety.

- A CT scan will be performed for each participant to exclude the recurrence or
metastasis of tumor and assess the effects of treatment once before the initiation of
each new cycle.

Inclusion Criteria


Perioperative Period Inclusion Criteria

1. Signed informed consent;

2. Aged ≥ 18 years and ≤ 75 years old, male or female;

3. Subject underwent a complete resection of hepatocellular carcinoma (confirmed by
pathology);

4. The tumor characteristics must meet one of the following:

- Tumor thrombosis in the portal vein branches is detected by either;

- Preoperative imaging, or;

- Intraoperative visual observation.

- Tumor thrombosis in the portal vein branches was not detected; and

- A single tumor with a maximum diameter ≥8cm confirmed by preoperative
imaging, and histological evidence of micro vascular tumor thrombosis; or

- Preoperative imaging confirmed that there are 2 or more tumor lesions

Perioperative Period Exclusion Criteria

1. Concomitant malignant primary tumor(s) in other systems is/are present;

2. Tumor thrombosis in the main branch of portal vein or in hepatic vein is detected by
preoperative imaging or observed during the surgery;

3. The subject received any previous systemic anti-HCC therapy prior to the resection
surgery (except the resection surgery), such as liver transplantation, intervention,
ablation, radiotherapy, chemotherapy, molecular targeted therapy or other anti-HCC
therapy;

4. The subject took other study/investigational drugs 7 days prior to the resection
surgery;

5. The subject has central nervous system disease, mental illness, unstable angina,
congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;

6. The subject has history of study drug or similar drug allergy

Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria

1. Baseline (post-resection) liver CT (normal CT + contrast enhanced CT) and chest CT
scan show no tumor lesions;

2. Child-Pugh score of class A at baseline

Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria

1. Body surface area is < 1.47 m2 or > 1.92 m2;

2. Concomitant malignant primary tumor(s) in other systems is/are present;

3. The subject took other study/investigational drugs within 4 weeks prior to
randomization;

4. The baseline examination indicates that infection, bleeding, bile leakage, or other
postoperative complications are present;

5. The baseline examination suggests the presence of tumor metastasis;

6. The subject has central nervous system disease, mental illness, unstable angina,
congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;

7. The subject has history of investigational drug or similar drug allergy;

8. The subject is pregnant, lactating, or urine pregnancy test result is positive

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

RFS(Recurrence Free Survival)

Outcome Description:

The time from randomization to recurrence, metastasis or death due to any reason

Outcome Time Frame:

0-2years

Safety Issue:

No

Principal Investigator

Tang ZhaoYou, Academician

Investigator Role:

Study Chair

Investigator Affiliation:

Fudan University Zhongshan Hospital

Authority:

China: Food and Drug Administration

Study ID:

TYS-CN-1.1PUMP III

NCT ID:

NCT01489566

Start Date:

July 2011

Completion Date:

August 2013

Related Keywords:

  • Hepatocellular,Carcinoma
  • Hepatocellular,Carcinoma,recurrence
  • Carcinoma
  • Carcinoma, Hepatocellular

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