Hepatocellular CarcinomaCCGLC-004NCT05103007
PVE/PVL Combined With DEB-TACE in the Treatment of Patients With Large and Unresectable Liver Cancer
A study testing DEB-TACE and PVL/PVE+DEB-TACE in people with Hepatocellular Carcinoma, run by Tongji Hospital at 1 site in China.
Trial summary
This is a multicenter, randomized, positive parallel controlled clinical study to evaluate the short-term and long-term efficacy and safety of PVL/PVE combined with DEB-TACE in the treatment of unresectable patients with large or large tumors in the right lobe of the liver. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- DEB-TACE and PVL/PVE+DEB-TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Jun 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed as large or giant hepatocellular carcinoma of the right lobe of the liver;
- Child-Pugh liver function grade A,
- ECOG PS 0-1
- If the tumor is resected with R0, the remaining liver volume is insufficient
- ICG-15R < 30%
- No serious organic diseases of heart, lung, brain and other organs;
- No history of other malignant tumors;
- The patient's survival time is expected to be more than 3 months.
Who cannot join
- Pregnant and lactating women
- History of organ transplant
- Tumor thrombus with portal vein trunk or left branch involved;
- distant metastasis;
- Patients with obvious liver cirrhosis (Plt < 100 × 10 ^ 9 / L at admission or gastroscopy suggested esophageal and gastric varices);
- Active bleeding caused by various causes;
- Suffering from severe acute or chronic diseases or infectious diseases;
- History of hepatectomy or TACE treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Wan-guang Zhang, M.D., +8613886195965, wgzhang@tjh.tjmu.edu.cn
About this study
Official title: A Multicenter, Randomized, Positive Parallel Controlled Clinical Trial of PVE/PVL Combined With DEB-TACE in the Treatment of Large or Large Liver Cancer in the Right Lobe of the Liver Without Hepatectomy
This is a multicenter, randomized, positive parallel controlled clinical study to evaluate the short-term and long-term efficacy and safety of PVL/PVE combined with DEB-TACE in the treatment of unresectable patients with large or large tumors in the right lobe of the liver.
Read the detailed description
Most guidelines recommend transarterial chemoembolization (TACE) as the standard of treatment for hepatocellular carcinoma（HCC）which is limited to the right half of the liver, single large or multiple, with / without tumor thrombus of the right branch of the portal vein.While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma. Portal vein embolization(PVE)/portal vein ligation(PVL) is the main means to increase the future liver remnant (FLR), which can reduce the complications after hepatectomy. TACE on the basis of PVE/PVL can not only increase FLR, but also can effectively control the progression of tumor by sequential TACE. This study intends to conduct a multicenter, randomized, positive parallel-controlled clinical study to objectively and scientifically evaluate the short-term and long-term efficacy and safety of ligation of the right portal vein combined with Drug-eluting bead transarterial chemoembolization(DEB-TACE) technique in the treatment of patients with large or large tumors of the right lobe who cannot be resected in I-stage.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- DEB-TACE, PVL/PVE+DEB-TACE
- Keywords
- Drug-eluting bead transarterial chemoembolization(DEB-TACE), portal vein embolization(PVE), portal vein ligation(PVL)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB-TACEProcedure or surgery
It is suggested that the tumor feeding artery should be selected for the microcatheter. The mixed volume of pirarubicin 80mg + microsphere 2g is about 2ml, and the mixture of at least 10ml and contrast medium is slowly injected with 5-10min.
PVL/PVE+DEB-TACEProcedure or surgery
DEB-TACE will be performed after the liver function recovered within 7-10 days. After that, conventional transarterial chemoembolization（cTACE) was performed every 2 months, a total of 2-3 times of chemoembolization.
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting bead transarterial chemoembolization（DEB-TACE) | Active comparator | Percutaneous drug-eluting bead transarterial chemoembolization, followed by conventional transarterial chemoembolization（cTACE) every 2 months. A total of 3 times of chemoembolization will be performed. Receives: Procedure: DEB-TACE |
| PVL/PVE+DEB-TACE | Experimental | PVL and PVE will be performed randomly assigned according to 1:1 according to the random number table. Receives: Procedure: PVL/PVE+DEB-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of tumor resection after treatment
Measured: Until one month after the last treatment.
FLR
the ratio of FLR proliferation after treatment
Measured: Until one month after the last treatment.
Secondary outcomes (2)
Overall survival (OS)
The overall survival time refers to the time from the first interventional therapy to the patient's death or the last follow-up, whichever appears early.
Measured: After operation, up to 3 years
Progression-free survival (PFS)
Disease progression-free survival time refers to the imaging evaluation of the patient after the first interventional therapy, the tumor does not continue to grow, new, distant metastasis; there is no increase in alpha-fetoprotein
Measured: 1, 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tongji 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Guang Zhang, Tongji Hospital
- Investigators
- Wan-guang Zhang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103007
- Sponsor's protocol ID
- TJ-IRB20210118
- Acronym
- CCGLC-004
- Status last verified
- Dec 2023
- First submitted
- 28 Oct 2021
- Last updated
- 19 Dec 2023
- 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 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Positive Parallel Controlled Clinical Trial of PVE/PVL Combined With DEB-TACE in the Treatment of Large or Large Liver Cancer in the Right Lobe of the Liver Without Hepatectomy
- ClinicalTrials.gov ID
- NCT05103007
- Acronym / sponsor ID
- CCGLC-004 / TJ-IRB20210118
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Drug-eluting bead transarterial chemoembolization(DEB-TACE), portal vein embolization(PVE), portal vein ligation(PVL)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Nov 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.
This is a multicenter, randomized, positive parallel controlled clinical study to evaluate the short-term and long-term efficacy and safety of PVL/PVE combined with DEB-TACE in the treatment of unresectable patients with large or large tumors in the right lobe of the liver.
Detailed description
Most guidelines recommend transarterial chemoembolization (TACE) as the standard of treatment for hepatocellular carcinoma（HCC）which is limited to the right half of the liver, single large or multiple, with / without tumor thrombus of the right branch of the portal vein.While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma. Portal vein embolization(PVE)/portal vein ligation(PVL) is the main means to increase the future liver remnant (FLR), which can reduce the complications after hepatectomy. TACE on the basis of PVE/PVL can not only increase FLR, but also can effectively control the progression of tumor by sequential TACE. This study intends to conduct a multicenter, randomized, positive parallel-controlled clinical study to objectively and scientifically evaluate the short-term and long-term efficacy and safety of ligation of the right portal vein combined with Drug-eluting bead transarterial chemoembolization(DEB-TACE) technique in the treatment of patients with large or large tumors of the right lobe who cannot be resected in I-stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting bead transarterial chemoembolization（DEB-TACE) | Active comparator | Procedure: DEB-TACEPercutaneous drug-eluting bead transarterial chemoembolization, followed by conventional transarterial chemoembolization（cTACE) every 2 months. A total of 3 times of chemoembolization will be performed. |
| PVL/PVE+DEB-TACE | Experimental | Procedure: PVL/PVE+DEB-TACEPVL and PVE will be performed randomly assigned according to 1:1 according to the random number table. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinically diagnosed as large or giant hepatocellular carcinoma of the right lobe of the liver;
- Child-Pugh liver function grade A,
- ECOG PS 0-1
- If the tumor is resected with R0, the remaining liver volume is insufficient
- ICG-15R < 30%
Key exclusion criteria (8 listed)
- Pregnant and lactating women
- History of organ transplant
- Tumor thrombus with portal vein trunk or left branch involved;
- distant metastasis;
- Patients with obvious liver cirrhosis (Plt < 100 × 10 ^ 9 / L at admission or gastroscopy suggested esophageal and gastric varices);
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 |
|---|---|---|
| DEB-TACEIt is suggested that the tumor feeding artery should be selected for the microcatheter. The mixed volume of pirarubicin 80mg + microsphere 2g is about 2ml, and the mixture of at least 10ml and contrast medium is slowly injected with 5-10min. | Procedure or surgery | Drug-eluting bead transarterial chemoembolization（DEB-TACE) |
| PVL/PVE+DEB-TACEDEB-TACE will be performed after the liver function recovered within 7-10 days. After that, conventional transarterial chemoembolization（cTACE) was performed every 2 months, a total of 2-3 times of chemoembolization. | Procedure or surgery | PVL/PVE+DEB-TACE |
Primary outcome
the rate of tumor resection after treatment
Time frame: Until one month after the last treatment.
FLR
Time frame: Until one month after the last treatment.
the ratio of FLR proliferation after treatment
2 secondary outcomes
Overall survival (OS)
Time frame: After operation, up to 3 years
Progression-free survival (PFS)
Time frame: 1, 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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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.
Wan-guang Zhang principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEB-TACE and PVL/PVE+DEB-TACE in people with Hepatocellular Carcinoma, run by Tongji 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 8 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 19 Dec 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.
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 Wan-guang Zhang, M.D. (+8613886195965, wgzhang@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of tumor resection after treatment (time frame: Until one month after the last treatment.). The study lists 2 primary outcomes in all. 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 19 Dec 2023.