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

NCT ID: NCT01489566

Last Updated: 2011-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-08-31

Brief Summary

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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

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* 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.

Conditions

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Hepatocellular,Carcinoma

Keywords

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Hepatocellular,Carcinoma,recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tyroserleutide for injection

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

Group Type ACTIVE_COMPARATOR

Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )

Intervention Type DRUG

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

the placebo

Group Type PLACEBO_COMPARATOR

the placebo ,chemotherapy(mitomycin, and Fluorouracil )

Intervention Type DRUG

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

Interventions

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Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )

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

the placebo ,chemotherapy(mitomycin, and Fluorouracil )

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

Intervention Type DRUG

Eligibility Criteria

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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


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

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


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role collaborator

Medpace, Inc.

INDUSTRY

Sponsor Role collaborator

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tang ZhaoYou, Academician

Role: STUDY_CHAIR

Shanghai Zhongshan Hospital

Wu Meng Chao, Academician

Role: STUDY_CHAIR

Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital

Fan Jia, professor

Role: STUDY_DIRECTOR

Shanghai Zhongshan Hospital

Yang Jia Mei, professor

Role: STUDY_DIRECTOR

Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital

Sun Hui Chuan, professor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Yan Yi Qun, professor

Role: PRINCIPAL_INVESTIGATOR

Second Milliary Medical University,Eastern Hepatobiliary Surgery Hosipital

Zheng Shu Sen, Academician

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of College of Medicine, Zhejiang Universtiy

Wu Yu Lian, professor

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital Zhejiang University School of Medicine

Dong Jia Hong, professor

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Sang Xin Ting, professor

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Chen Min Shan, professor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Guo Rong Ping, professor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Zheng Qi Chang, professor

Role: PRINCIPAL_INVESTIGATOR

Tongji Medical College,Huazhong University of Science and Technology Wuhan Union Hospital

Xia Xiao Qin, professor

Role: PRINCIPAL_INVESTIGATOR

Hubei Cancer Hospital

Liu Jing Feng, professor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Chen Yan Ling, professor

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Ying Min Gang, professor

Role: PRINCIPAL_INVESTIGATOR

Fujian Cancer Hospital

Shi Xue Tao, professor

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Liu Jun, professor

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Hospital

Liu Ji Yong, professor

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Hospital

Wu Jin Shu, professor

Role: PRINCIPAL_INVESTIGATOR

Hunan Provincial People's Hospital

Wang Zhi Ming, professor

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Yang Xun, professor

Role: PRINCIPAL_INVESTIGATOR

Sichuan Provincial People's Hospital

Yan Lv Nan, professor

Role: PRINCIPAL_INVESTIGATOR

West China Hospital,Sichuan Universtiy

Bie Ping, professor

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Ma Kuan Sheng, professor

Role: PRINCIPAL_INVESTIGATOR

Southwest Hospital, China

Liu Qing Guang, professor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Han Ying, professor

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Wang Xue Hao, professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Ding Yi Tao, professor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Hao Xi Shan, Academician

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Liu Lian Xin, professor

Role: PRINCIPAL_INVESTIGATOR

Center of First Affiliated Hospital of Harbin Medical University

Li Wei, professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Jilin University

Wang Guang Yi, professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Jilin University

Jiang Bo, professor

Role: PRINCIPAL_INVESTIGATOR

Hunan Provincial People's Hospital

Du Qin, professor

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital Zhejiang University School of Medicine

Locations

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Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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TYS-CN-1.1PUMP III

Identifier Type: -

Identifier Source: org_study_id