NCT04961138

Unknown

Pre-operative Neoadjuvant Therapy Combined With Surgery for ...

Second Affiliated Hospital, Zhejiang University, School of Medicine Source

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Other study identifiers

Sponsor study identifier

2019-01

Study Type

interventional

Estimated enrollment

164

Locations

0 countries

Sites

N/A

Timeline

Study Start

August 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 164 participants
Study completion date: March 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 16, 2019
Actual (reported)
First Posted
July 14, 2021
Actual (reported)
Study Start
August 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: July 14, 2021
Status Verified: July 2021
Last Update Submitted: July 12, 2021

Conditions

Hepatocellular Carcinoma Stage III

Outcome Measures

Primary Outcomes (1)

1-year disease free survival
1 year

Secondary Outcomes (3)

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

Study Arms (2)

Neoadjuvant group

EXPERIMENTAL

Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE)

Surgery group

ACTIVE COMPARATOR

Procedure: Surgery

Interventions

Transhepatic Arterial Chemotherapy And Embolization (TACE)Procedure

Receiving TACE and lenvatinib before surgery.

Also known as: lenvatinib

Neoadjuvant group

SurgeryProcedure

Removing tumor by surgery.

Surgery group

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18-80 years old, both gender
Confirmed diagnosis of stage III hepatocellular carcinoma(HCC)

Sponsors & Collaborators

Second Affiliated Hospital, Zhejiang University, School of Medicine
Otherlead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Embolization, TherapeuticlenvatinibSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Yuan Ding, MD

CONTACT

+8618858101960 dingyuandy@126.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

July 14, 2021

Study Start

August 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2022

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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Fulfill the criteria of surgery

No other severe comorbidity

Eastern Cooperative Oncology Group score(ECOG) 0-2

Expected survival \> 3months

Informed consent obtained.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

March 2023

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

July 14, 2021

Record last verified: 2021-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04961138
Data provider: ClinicalTrials.gov
Source updated: 2021-07-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:51 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Neoadjuvant group

Surgery group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record