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

Naval Military Medical University (Second Military Medical University)

Status and phase: Completed; Phase 1

Conditions: Hepatocellular Carcinoma; Rapamycin

Treatments: Drug: Rapamycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02724332

ZD201206003-P1

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

control group

No Intervention group

Description:

Patients will be treated with radical hepatectomy only.

transcatheter arterial chemoembolization

Active Comparator group

Description:

Patients will be treated with TACE

Treatment:

Drug: Rapamycin