Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma
1 other identifier
interventional
164
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2019
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedJuly 14, 2021
July 1, 2021
1.3 years
October 16, 2019
July 12, 2021
Conditions
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
EXPERIMENTALSurgery group
ACTIVE COMPARATORInterventions
Receiving TACE and lenvatinib before surgery.
Eligibility Criteria
You may qualify if:
- 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.
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.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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 1, 2021
Primary Completion
December 1, 2022
Study Completion
March 1, 2023
Last Updated
July 14, 2021
Record last verified: 2021-07