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

Phase 1

Completed

• Conditions: Rapamycin; Hepatocellular Carcinoma
• Interventions: Drug: Rapamycin

• Registration Number: NCT02724332
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2015-06
• Study Completion: 2015-12
• Status Verified: 2016-03
• Study First Submitted: 2016-03-28
• Study First Submitted QC: 2016-03-28
• Last Update Submitted: 2016-03-28
• Study First Posted: 2016-03-31
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transcatheter arterial chemoembolization	Rapamycin	Patients will be treated with TACE

Primary Outcome Measures

Name	Time	Method
Overall Survival	3 years

Secondary Outcome Measures

Name	Time	Method
Time to recurrence	3 years

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China