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Completed

NCT Number: NCT02724332

Adjuvant Anti-Recurrence Treatment With Rapamycin on Early-stage HCC

To evaluate the clinical effect of rapamycin combined with TACE on early-stage HCC with overexpression of ASPH after radical surgery using randomized controlled study and provide a new anti-recurrence treatment for HCC patients after operation.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Via clinical diagnosis and confirm it is primary liver cancer
  • Pathological evidence of HCC
  • Estimate tumor can gain treatment of curing operation
  • No evidence for extrahepatic metestasis
  • liver function ：Child-Pugh A/B
  • BCLC stage：0/1；TNM stage：Ⅰ

Exclusion criteria

  • reject to attend；
  • impossible to come to our hospital for physical examination regularly.
  • cancer epitome、seed focus、lymph node or distant metastasis
  • Blood clotting function hindrance; 5, Patients with other diseases which may affect the treatment mentioned.

Treatment and study plan

Rapamycin

Drug

2mg,po,bid

Primary outcomes

  1. Overall Survival

    Time frame: 3 years

Secondary outcomes

  1. Time to recurrence

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

A Randomized Controlled Study on the Effect of Adjuvant Anti-recurrence Treatment With Rapamycin on Early-stage HCC With Overexpression of ASPH After Radical Surgery.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2016
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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