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

NCT ID: NCT04961138

Last Updated: 2021-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma Stage III

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neoadjuvant group

Group Type EXPERIMENTAL

Transhepatic Arterial Chemotherapy And Embolization (TACE)

Intervention Type PROCEDURE

Receiving TACE and lenvatinib before surgery.

Surgery group

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

Removing tumor by surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transhepatic Arterial Chemotherapy And Embolization (TACE)

Receiving TACE and lenvatinib before surgery.

Intervention Type PROCEDURE

Surgery

Removing tumor by surgery.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

lenvatinib

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yuan Ding, MD

Role: CONTACT

+8618858101960

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.