Hepatocellular Carcinoma Stage III
Conditions
Brief summary
The purpose of present study is to evaluate whether per-operative neoadjuvant therapy combined with surgery could improve the 1-year disease-free survival of stage III hepatocellular carcinoma patients.
Interventions
PROCEDURETranshepatic Arterial Chemotherapy And Embolization (TACE)
Receiving TACE and lenvatinib before surgery.
PROCEDURESurgery
Removing tumor by surgery.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years old, both gender * Confirmed diagnosis of stage III hepatocellular carcinoma(HCC) * Fulfill the criteria of surgery * No other severe comorbidity * Eastern Cooperative Oncology Group score(ECOG) 0-2 * Expected survival \> 3months * Informed consent obtained.
Exclusion criteria
* Received chemoradiotherapy or other antineoplastic drugs * Severe cirrhosis with Child-Pugh score \>10 * Total bilirubin \> 1.5 times upper limit, AST or ALT \> 2times upper limit, indocyanine green retention rate after 15 min(ICG15) \>=40%; * Not fulfill the surgery criteria * Received major surgery within 1month * History of other tumor * Participate other clinical trial within 1month * Drug or alcohol abuse, AIDS * Uncontrollable epileptic seizure or cognitive disorder * Severe allergy * Other unsuitable conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year disease free survival | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 1-year overall survival | 1 year |
| Rate of R0 resection | 1 week |
| objective response rate | up to 2 months |
Contacts
Primary ContactYuan Ding, MD
Outcome results
None listed