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

Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma: an Open, Random, Multicenter, Prospective Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma Stage III
• Intervention / Treatment: Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE); Procedure: Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Ding, MD; Phone Number: +8618858101960; Email: dingyuandy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Neoadjuvant group	Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE); Receiving TACE and lenvatinib before surgery.; Other Names: lenvatinib
ACTIVE_COMPARATOR: Surgery group	Procedure: Surgery; Removing tumor by surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1-year disease free survival	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
1-year overall survival	1 year
Rate of R0 resection	1 week
objective response rate	up to 2 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (ACTUAL): July 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: 2019-01 (Other Identifier: NANT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No