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

Zhejiang University

Status: Unknown

Conditions: Hepatocellular Carcinoma Stage III

Treatments: Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE); Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04961138

2019-01

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 2 patient groups

Neoadjuvant group

Experimental group

Treatment:

Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE)

Surgery group

Active Comparator group

Treatment:

Procedure: Surgery