Carcinoma, HepatocellularPhase 3NCT03939845
A Prospective, Randomized, Multicenter Study of Comparison of TACE Combination With and Without EBRT for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi
A Phase 3 study testing RT and TACE in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The 1-year and 2-year overall survival rate (OS), local control rate (FFLP), disease-free progression time (PFS), and side effects were compared in patients with hepatocellular carcinoma limited to intrahepatic unresectable hepatocellular carcinoma with portal venous thrombosis combined with or without external… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- RT and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2019to 23 Apr 2022
- 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
- confirmed by pathology or met the clinical diagnostic criteria of hepatocellular carcinoma.
- after the joint consultation between the interventional department and the radiotherapy department, the patients who were considered to be interventional were considered. Meeting the following criteria: the tumor was confined to the liver (meeting the liver tolerance dose), and was diagnosed as type II or type III portal vein tumor thrombi according to chang's classification criteria, without extrahepatic metastasis. Number of tumors in liver parenchyma: less than or equal to 3. The main portal vein is not completely blocked or the compensatory collateral vessels of the portal vein are abundant although it is completely blocked.
- patients who meet all the following criteria: Child-Pugh score ≤7, PLT>30×109/L, WBC>3×10^9/L/ANC>1.5×10^9/L,Hb>90g/L, Cr<2.0mg/dL.
- ECOG score 0-2 points.
- estimated survival time > 3 months.
- age > 18.
- sign the informed consent.
Who cannot join
- patients with the following condition: the number of intrahepatic tumors >3 or total tumor diameter>15cm.
- patients with signs of extrahepatic metastasis, including but not limited to inferior vena cava carcinoma thrombus, bone metastasis, brain metastasis or regional lymph node metastasis.
- patients with West Haven standard grade III/IV hepatic encephalopathy or ascites.
- patients with a history of malignancy other than primary HCC, except for cutaneous squamous cell carcinoma or basal cell carcinoma.
- patients with a history of upper abdominal radiotherapy.
- in the radiotherapy plan, patients who failed to follow the radiation dose limit of important organs, including those whose normal liver tissue was less than 700 ml in the radiotherapy plan.
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- screening patients who have received other study drugs within 4 weeks prior to the start of the visit.
- screening: patients who had received treatment for other local or systemic hepatocellular carcinoma within 4 weeks before the visit.
- patients with significant concurrent diseases.
- lactating or pregnant female patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hosptial
Shanghai, Shanghai Municipality, 200032
jiazhou hou, +8602164041990 ext. +8602164041990, hou.jiazhou@zs-hosptial.sh.cn
About this study
Official title: A Prospective, Randomized, Multicenter Study of Comparison of Transarterial Chemoembolization (TACE) Combination With and Without External- Beam Radiotherapy (EBRT) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi
The 1-year and 2-year overall survival rate (OS), local control rate (FFLP), disease-free progression time (PFS), and side effects were compared in patients with hepatocellular carcinoma limited to intrahepatic unresectable hepatocellular carcinoma with portal venous thrombosis combined with or without external radiotherapy, providing a basis for the development of relevant guidelines.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- RT, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTRadiation
external- beam radiotherapy (EBRT)
TACEProcedure or surgery
transarterial chemoembolization (TACE)
| Study group | Role | What they receive |
|---|---|---|
| TACE | Active comparator | Not described Receives: Procedure: TACE |
| TACE+RT | Experimental | Not described Receives: Radiation: RT; Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
overall survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start23 Apr 2019
- Primary completion23 Apr 2021 (estimated)
- Study completion23 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939845
- Sponsor's protocol ID
- PVT/RT
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Study of Comparison of Transarterial Chemoembolization (TACE) Combination With and Without External- Beam Radiotherapy (EBRT) for Hepatocellular Carcinoma With Portal Vein Tumor Thrombi
- ClinicalTrials.gov ID
- NCT03939845
- Acronym / sponsor ID
- PVT/RT
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 23 Apr 2021 (estimated)
- Study completion
- 23 Apr 2022 (estimated)
- First posted
- 7 May 2019 (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 1-year and 2-year overall survival rate (OS), local control rate (FFLP), disease-free progression time (PFS), and side effects were compared in patients with hepatocellular carcinoma limited to intrahepatic unresectable hepatocellular carcinoma with portal venous thrombosis combined with or without external radiotherapy, providing a basis for the development of relevant guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE | Active comparator | Procedure: TACE |
| TACE+RT | Experimental | Radiation: RT, Procedure: TACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- confirmed by pathology or met the clinical diagnostic criteria of hepatocellular carcinoma.
- after the joint consultation between the interventional department and the radiotherapy department, the patients who were considered to be interventional were considered. Meeting the following criteria: the tumor was confined to the liver (meeting the liver tolerance dose), and was diagnosed as type II or type III portal vein tumor thrombi according to chang's classification criteria, without extrahepatic metastasis. Number of tumors in liver parenchyma: less than or equal to 3. The main portal vein is not completely blocked or the compensatory collateral vessels of the portal vein are abundant although it is completely blocked.
- patients who meet all the following criteria: Child-Pugh score ≤7, PLT>30×109/L, WBC>3×10^9/L/ANC>1.5×10^9/L,Hb>90g/L, Cr<2.0mg/dL.
- ECOG score 0-2 points.
- estimated survival time > 3 months.
Key exclusion criteria (10 listed)
- patients with the following condition: the number of intrahepatic tumors >3 or total tumor diameter>15cm.
- patients with signs of extrahepatic metastasis, including but not limited to inferior vena cava carcinoma thrombus, bone metastasis, brain metastasis or regional lymph node metastasis.
- patients with West Haven standard grade III/IV hepatic encephalopathy or ascites.
- patients with a history of malignancy other than primary HCC, except for cutaneous squamous cell carcinoma or basal cell carcinoma.
- patients with a history of upper abdominal radiotherapy.
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 |
|---|---|---|
| RTexternal- beam radiotherapy (EBRT) | Radiation | TACE+RT |
| TACEtransarterial chemoembolization (TACE) | Procedure or surgery | TACE, TACE+RT |
Primary outcome
OS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
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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.
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 RT and TACE in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan Hospital 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 7 inclusion and 10 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 7 May 2019. 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 jiazhou hou, doctor (+86-021-64041990 ext. 2764, hou.jiazhou@zs-hosptial.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). 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 7 May 2019; AzTrials last refreshed its copy on 6 Nov 2026.