Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma
Not Applicable
- Conditions
- Hepatocellular Carcinoma Stage III
- Interventions
- Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE)Procedure: Surgery
- Registration Number
- NCT04961138
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 164
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neoadjuvant group Transhepatic Arterial Chemotherapy And Embolization (TACE) - Surgery group Surgery -
- Primary Outcome Measures
Name Time Method 1-year disease free survival 1 year
- Secondary Outcome Measures
Name Time Method 1-year overall survival 1 year objective response rate up to 2 months Rate of R0 resection 1 week