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Study of Tyroserleutide for Injection in Hepatocellular Carcinoma (HCC) Patients

Primary Purpose

Hepatocellular,Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )

the placebo ,chemotherapy(mitomycin, and Fluorouracil )

About this trial

This is an interventional treatment trial for Hepatocellular,Carcinoma focused on measuring Hepatocellular,Carcinoma,recurrence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Perioperative Period Inclusion Criteria

Signed informed consent;
Aged ≥ 18 years and ≤ 75 years old, male or female；
Subject underwent a complete resection of hepatocellular carcinoma (confirmed by pathology);
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

Concomitant malignant primary tumor(s) in other systems is/are present;
Tumor thrombosis in the main branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery;
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;
The subject took other study/investigational drugs 7 days prior to the resection surgery;
The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;
The subject has history of study drug or similar drug allergy

Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria

Baseline (post-resection) liver CT (normal CT + contrast enhanced CT) and chest CT scan show no tumor lesions;
Child-Pugh score of class A at baseline

Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria

Body surface area is < 1.47 m2 or > 1.92 m2;
Concomitant malignant primary tumor(s) in other systems is/are present;
The subject took other study/investigational drugs within 4 weeks prior to randomization;
The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present;
The baseline examination suggests the presence of tumor metastasis;
The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases;
The subject has history of investigational drug or similar drug allergy;
The subject is pregnant, lactating, or urine pregnancy test result is positive

Sites / Locations

Fudan University Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tyroserleutide for injection

the placebo

Arm Description

the Tyroserleutide for injection at the dosage of 6mg/d

Outcomes

Primary Outcome Measures

RFS(Recurrence Free Survival)

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

Secondary Outcome Measures

OS （Overall Survival）

The time from randomization to death due to any reason

QOL score

Quality of life score

Full Information

NCT ID

NCT01489566

First Posted

December 1, 2011

Last Updated

December 13, 2011

Sponsor

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Collaborators

Fudan University, Medpace, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01489566

Brief Title

Study of Tyroserleutide for Injection in Hepatocellular Carcinoma (HCC) Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

July 2011 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Collaborators

Fudan University, Medpace, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions one month after resection of hepatocellular carcinoma will be randomized in a 1:1 ratio to 1 of the 2 treatment groups：6mg/d Tyroserleutide (injection), or placebo. The objective is to evaluate the effect of Injectable Tyroserleutide on the recurrence-free survival,overall survival,quality of life,and the safety and tolerability of subjects after the resection of hepatocellular carcinoma

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular,Carcinoma

Keywords

Hepatocellular,Carcinoma,recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tyroserleutide for injection

Arm Type

Active Comparator

Arm Description

the Tyroserleutide for injection at the dosage of 6mg/d

Arm Title

the placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )

Intervention Description

mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; Tyroserleutide for injection(30mg) ,through the micro infusion pump,every cycle,3-5 days

Intervention Type

Drug

Intervention Name(s)

the placebo ,chemotherapy(mitomycin, and Fluorouracil )

Intervention Description

mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; the placebo(30mg) ,through the micro infusion pump,every cycle,3-5 days

Primary Outcome Measure Information:

Title

RFS(Recurrence Free Survival)

Description

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

Time Frame

0-2years

Secondary Outcome Measure Information:

Title

OS （Overall Survival）

Description

The time from randomization to death due to any reason

Time Frame

0-2years

Title

QOL score

Description

Quality of life score

Time Frame

0-2years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Perioperative Period Inclusion Criteria Signed informed consent; Aged ≥ 18 years and ≤ 75 years old, male or female； Subject underwent a complete resection of hepatocellular carcinoma (confirmed by pathology); 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 Concomitant malignant primary tumor(s) in other systems is/are present; Tumor thrombosis in the main branch of portal vein or in hepatic vein is detected by preoperative imaging or observed during the surgery; 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; The subject took other study/investigational drugs 7 days prior to the resection surgery; The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases; The subject has history of study drug or similar drug allergy Baseline (Post-SurgeryDay 25 ± 5) Inclusion Criteria Baseline (post-resection) liver CT (normal CT + contrast enhanced CT) and chest CT scan show no tumor lesions; Child-Pugh score of class A at baseline Baseline (Post-SurgeryDay 25 ± 5) Exclusion Criteria Body surface area is < 1.47 m2 or > 1.92 m2; Concomitant malignant primary tumor(s) in other systems is/are present; The subject took other study/investigational drugs within 4 weeks prior to randomization; The baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present; The baseline examination suggests the presence of tumor metastasis; The subject has central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia or other severe uncontrolled diseases; The subject has history of investigational drug or similar drug allergy; The subject is pregnant, lactating, or urine pregnancy test result is positive

Overall Study Officials: