Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma

Not Applicable

• Conditions: Hepatocellular Carcinoma Stage III

• 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

Study Timeline

• Study First Submitted: 2019-10-16
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-12
• Last Update Submitted: 2021-07-12
• Study First Posted: 2021-07-14
• Last Update Posted: 2021-07-14
• Study Start: 2021-08
• Primary Completion: 2022-12
• Study Completion: 2023-03

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

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