Hepatocellular Carcinoma Stage IIINCT04961138
Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma
A study testing Transhepatic Arterial Chemotherapy And Embolization (TACE) and Surgery in people with Hepatocellular Carcinoma Stage III, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma Stage III
- What is being tested?
- Transhepatic Arterial Chemotherapy And Embolization (TACE) and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- Participate other clinical trial within 1month
- Drug or alcohol abuse, AIDS
- Uncontrollable epileptic seizure or cognitive disorder
- Severe allergy
- Other unsuitable conditions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma Stage III
- Being tested
- Transhepatic Arterial Chemotherapy And Embolization (TACE), Surgery
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transhepatic Arterial Chemotherapy And Embolization (TACE)Procedure or surgery
Also called lenvatinib
Receiving TACE and lenvatinib before surgery.
SurgeryProcedure or surgery
Removing tumor by surgery.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant group | Experimental | Not described Receives: Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE) |
| Surgery group | Active comparator | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year disease free survival
Measured: 1 year
Secondary outcomes (3)
1-year overall survival
Measured: 1 year
Rate of R0 resection
Measured: 1 week
objective response rate
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Stage IIIStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961138
- Sponsor's protocol ID
- 2019-01
- Status last verified
- Jul 2021
- First submitted
- 16 Oct 2019
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Neoadjuvant Therapy Combined With Surgery for Treating Stage III Hepatocellular Carcinoma: an Open, Random, Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT04961138
- Acronym / sponsor ID
- 2019-01
- Conditions
- Hepatocellular Carcinoma Stage III
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant group | Experimental | Procedure: Transhepatic Arterial Chemotherapy And Embolization (TACE) |
| Surgery group | Active comparator | Procedure: Surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transhepatic Arterial Chemotherapy And Embolization (TACE)Also: lenvatinibReceiving TACE and lenvatinib before surgery. | Procedure or surgery | Neoadjuvant group |
| SurgeryRemoving tumor by surgery. | Procedure or surgery | Surgery group |
Primary outcome
1-year disease free survival
Time frame: 1 year
3 secondary outcomes
1-year overall survival
Time frame: 1 year
Rate of R0 resection
Time frame: 1 week
objective response rate
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatocellular Carcinoma Stage III
Active, not recruitingPhase 3
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7
Active, not recruitingPhase 1/2
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Not yet recruitingPhase 3
A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
Hepatocellular Carcinoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial
Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Transhepatic Arterial Chemotherapy And Embolization (TACE) and Surgery in people with Hepatocellular Carcinoma Stage III, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Ding, MD (+8618858101960, dingyuandy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year disease free survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.