Unresectable Hepatocellular CarcinomaPhase 3NCT04387695
SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT
A Phase 3 study testing SBRT+TACE+Sorafenib and Sorafenib in people with Unresectable Hepatocellular Carcinoma and Portal Vein Thrombosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma, Portal Vein Thrombosis
- What is being tested?
- SBRT+TACE+Sorafenib and Sorafenib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2020to 1 Aug 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Child-Pugh score ≤ 7
- Performance status: ECOG score ≤ 2
- HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
- the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline
- No previous therapy for HCC
Show all 13Show fewer
- at least one measurable target lesion according to RECIST 1.1
- Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3
- Serum total bilirubin ≤ 2 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN
- Creatinine ≤ 1.5 x ULN
- No plan for pregnancy or breast feeding. Active contraception.
- Willing to give informed consent
Who cannot join
- Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
- Complete obstruction of hepatic outflow
- Uncontrolled ascites of hepatic encephalopathy
- Prior liver transplantation
- Positive for human immunodeficiency virus (HIV)
- Active gastric or duodenal ulcer
- Other uncontrolled comorbidities or malignancy
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Jun-hui Sun, MD,PH.D, +86-0571-87236815, 1307005@zju.edu.cn
Tan-yang Zhou, MD,PH.D, +86-0571-87236812, zhoutanyang@zju.edu.cn
About this study
Official title: SBRT Sequential TACE Combined With Sorafenib Versus Sorafenib Alone in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus：A Single-center Randomized Controlled Study
To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.
Read the detailed description
HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.
- Being tested
- SBRT+TACE+Sorafenib, Sorafenib
- Keywords
- Hepatocellular Carcinoma,Portal Vein Tumor Thrombus, Radiation ,Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT+TACE+SorafenibRadiation
Also called Stereotactic Body Radiation Therapy
SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later
SorafenibDrug
Also called Nexavar
Sorafenib 800 mg/day orally
| Study group | Role | What they receive |
|---|---|---|
| SBRT + TACE + Sorafenib | Experimental | SBRT sequential TACE combined with Sorafenib Receives: Radiation: SBRT+TACE+Sorafenib |
| Sorafenib | Active comparator | Sorafenib 800 mg/day orally Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) rate
Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
Measured: at 12 weeks after randomization
Secondary outcomes (4)
Radiologic response rate
Radiologic response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Measured: at 12 weeks after randomization
Overall patient survival rate
The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.
Measured: up to 2 years after randomization
Objective response rate
Objective response rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Measured: at 12 weeks and up to 2 years after randomization
Disease control rate
Disease control rate by independent radiologic review according to mRECIST criteria , assessed by Chi-square test or Fisher's exact test, as appropriate.
Measured: at 12 weeks and up to 2 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start30 Apr 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun-hui Sun, MD,PH.D, Study director, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387695
- Sponsor's protocol ID
- HEPIC2001
- Status last verified
- Feb 2023
- First submitted
- 11 May 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT Sequential TACE Combined With Sorafenib Versus Sorafenib Alone in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus：A Single-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04387695
- Acronym / sponsor ID
- HEPIC2001
- Keywords
- Hepatocellular Carcinoma,Portal Vein Tumor Thrombus, Radiation ,Sorafenib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 14 May 2020 (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.
To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.
Detailed description
HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT + TACE + Sorafenib | Experimental | Radiation: SBRT+TACE+SorafenibSBRT sequential TACE combined with Sorafenib |
| Sorafenib | Active comparator | Drug: SorafenibSorafenib 800 mg/day orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age >18 years
- Child-Pugh score ≤ 7
- Performance status: ECOG score ≤ 2
- HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
- the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline
Key exclusion criteria (8 listed)
- Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
- Complete obstruction of hepatic outflow
- Uncontrolled ascites of hepatic encephalopathy
- Prior liver transplantation
- Positive for human immunodeficiency virus (HIV)
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 |
|---|---|---|
| SBRT+TACE+SorafenibAlso: Stereotactic Body Radiation TherapySBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later | Radiation | SBRT + TACE + Sorafenib |
| SorafenibAlso: NexavarSorafenib 800 mg/day orally | Drug | Sorafenib |
Primary outcome
Progression-free survival (PFS) rate
Time frame: at 12 weeks after randomization
Progression is defined as progressive disease (PD) by independent radiologic review according to mRECIST criteria, termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.
4 secondary outcomes
Radiologic response rate
Time frame: at 12 weeks after randomization
Overall patient survival rate
Time frame: up to 2 years after randomization
Objective response rate
Time frame: at 12 weeks and up to 2 years after randomization
Disease control rate
Time frame: at 12 weeks and up to 2 years after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Unresectable Hepatocellular Carcinoma
Not yet recruitingPhase 2
PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC
Hepatocellular Carcinoma
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
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
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.
Jun-hui Sun, MD,PH.D study director
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SBRT+TACE+Sorafenib and Sorafenib in people with Unresectable Hepatocellular Carcinoma and Portal Vein Thrombosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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 13 inclusion and 8 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 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jun-hui Sun, MD,PH.D (+86-0571-87236815, 1307005@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) rate (time frame: at 12 weeks after randomization). 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 16 Feb 2023.