Expanding Phase III Study of Tyroserleutide for Injection

NCT03516448 | Unknown Phase 3 DMC

• 1 other identifier: TYS-CN-1.1PUMP III(C)
• Study Type: interventional
• Target: 352
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double-blinded, placebo-controlled, multi-center Clinical Trial. Patients with no tumor lesions 21 days 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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS （Overall Survival）

  The time from randomization to death due to any reason

  3 years

Secondary Outcomes (1)

• RFS(Recurrence Free Survival)

  3 years

Study Arms (2)

the Tyroserleutide for injection

ACTIVE COMPARATOR

the Tyroserleutide for injection at the dosage of 6mg/d Gan Fu Le Tablets，6 tablets,po,tid

Drug: Gan Fu Le Tablets; Drug: Tyroserleutide for injection

the placebo group

PLACEBO COMPARATOR

the placebo Gan Fu Le Tablets，6 tablets,po,tid

Drug: Gan Fu Le Tablets; Drug: Placebo

Interventions

Gan Fu Le Tablets DRUG

6 Tablets，tid,po

the Tyroserleutide for injection; the placebo group

Tyroserleutide for injection DRUG

6mg/d, 5days,ivgtt

the Tyroserleutide for injection

Placebo DRUG

0mg/d, 5days,ivgtt

the placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Aged ≥ 18 years and ≤ 75 years old, male or female
• Subject underwent resection of hepatocellular carcinoma (confirmed by pathology)
• The tumor characteristics must meet the following:A single tumor with a maximum diameter \>5cm ,Preoperative imaging, or Intraoperative visual observation.;

You may not qualify if:

• Concomitant malignant tumor(s) in other systems is/are present
• Tumor thrombosis in the 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 Sorafenib prior to randomization
• The subject took other study/investigational drugs 7 days prior to randomization
• The subject took Kang Laike injection/soft capsule，or Jinke Huaier granule 7 days prior to randomization
• 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 baseline examination indicates that infection, bleeding, bile leakage, or other postoperative complications are present
• The subject is pregnant, lactating, or urine pregnancy test result is positive
• Baseline (post-resection) examination exist tumor recurrence or metastasis;

Sponsors & Collaborators

• Shenzhen Kangzhe Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

H-Tyr-Ser-Leu-OH; Injections

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: May 4, 2018
• Study Start: March 24, 2016
• Primary Completion: June 13, 2016
• Study Completion: June 1, 2019
• Last Updated: May 4, 2018

Record last verified: 2018-04