Advanced Hepatocellular CarcinomaNCT06624098
Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma
A study testing Early TIPS in people with Advanced Hepatocellular Carcinoma and Variceal Bleeding, run by Sun Yat-sen University at 2 sites in China.
Trial summary
Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma, Variceal Bleeding
- What is being tested?
- Early TIPS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2024to 30 Jun 2026
- 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
- diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- presence of PVTT with III-IV grade by Cheng's criteria;
- having PVTT induced portal hypertension;
- TIPS was performed within 72 hours after the endoscopic hemostasis;
- metastases with limited five sites and no more two organs involved;
- number of Intrahepatic tumors were no more than five;
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- receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
- classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
- no history of other malignancies;
- agreed to participated in this clinical trial;
- Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.
Who cannot join
- recurrent HCC;
- PVTT at I-II grade by Cheng's criteria;
- age < 18 years or > 75 years;
- advanced HCC with more than five metastases;
- Number of Intrahepatic tumors were more than five;
- no response to Lenvatinib;
- life expectancy less than 3 months.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Chinese PLA General hospital
Beijing, Beijing Municipality, 100853
Qunfang Zhou, MD, 8619868000115, zhouqun988509@163.com
Feng Duan, MD, 8613910984586, duanfeng@vip.sina.com
- Recruiting
Chinese PLA General hospital
Beijing, Beijing Municipality, 100853
Qunfang Zhou, MD, 86 19868000115, zhouqun988509@163.com
Feng Duan, MD, 86 13910984586, duanfeng@vip.sina.com
About this study
Official title: Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study
Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.
Read the detailed description
Portal hypertension by main trunk portal vein tumor thrombus (PVTT) is a severe disease. Patients usually die of gastrointestinal hemorrhage rather than tumor progression. It is vital to prevent the portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method to alleviate the portal pressure. Then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. However, the PVTT induced portal hypertension still needs clinical evidence. In this study, the investigators explore the early TIPS for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. The investigators aim to added clinical evidence for this subtype of advanced HCC.
- Being tested
- Early TIPS
- Keywords
- Advanced hepatocellular carcinoma, Variceal bleeding, Therapeutic endoscopy, Transjugular intrahepatic portosystemic shunt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early TIPSProcedure or surgery
TIPS was performed within 72 hours after the endoscopic hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Early transjugular intrahepatic portosystemic shunt (TIPS) | Experimental | TIPS was performed within 72 hours after the endoscopic hemostasis. Receives: Procedure: Early TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of technical success
Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS.
Measured: 3 months
Secondary outcomes (5)
Rates of gastrointestinal hemorrhage
Patients occur gastrointestinal hemorrhage within 6 months after TIPS.
Measured: 6 months
Progression-Free-Survival (PFS)
Progression was defined as progressive disease by independent radiologic review.
Measured: 12 months
Overall survival (OS)
OS is the length of time from the date of inclusion until death from any cause.
Measured: 12 months
Objective response rate (ORR)
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.
Measured: 12 months
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Early transjugular intrahepatic portosystemic shunt (TIPS) within 72 hours after acute variceal bleeding.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Principal investigator, Zhou Qunfang, Sun Yat-sen University
- Investigators
- Feng Duan, MD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624098
- Sponsor's protocol ID
- Liver Projiect 12
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus Induced Gastrointestinal Bleeding: a Multicenter Phase II Study
- ClinicalTrials.gov ID
- NCT06624098
- Acronym / sponsor ID
- Liver Projiect 12
- Keywords
- Advanced hepatocellular carcinoma, Variceal bleeding, Therapeutic endoscopy, Transjugular intrahepatic portosystemic shunt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Oct 2024 (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.
Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.
Detailed description
Portal hypertension by main trunk portal vein tumor thrombus (PVTT) is a severe disease. Patients usually die of gastrointestinal hemorrhage rather than tumor progression. It is vital to prevent the portal hypertension. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective method to alleviate the portal pressure. Then the risk of gastrointestinal hemorrhage is decreased which provides an opportunity for system therapy. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective for cirrhosis induced portal hypertension. However, the PVTT induced portal hypertension still needs clinical evidence. In this study, the investigators explore the early TIPS for advanced hepatocellular carcinoma with main trunk portal vein tumor thrombus induced acute variceal bleeding. The investigators aim to added clinical evidence for this subtype of advanced HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Early transjugular intrahepatic portosystemic shunt (TIPS) within 72 hours after acute variceal bleeding.
| Arm | Type | Receives |
|---|---|---|
| Early transjugular intrahepatic portosystemic shunt (TIPS) | Experimental | Procedure: Early TIPSTIPS was performed within 72 hours after the endoscopic hemostasis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- presence of PVTT with III-IV grade by Cheng's criteria;
- having PVTT induced portal hypertension;
- TIPS was performed within 72 hours after the endoscopic hemostasis;
- metastases with limited five sites and no more two organs involved;
Key exclusion criteria (7 listed)
- recurrent HCC;
- PVTT at I-II grade by Cheng's criteria;
- age < 18 years or > 75 years;
- advanced HCC with more than five metastases;
- Number of Intrahepatic tumors were more than five;
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 |
|---|---|---|
| Early TIPSTIPS was performed within 72 hours after the endoscopic hemostasis. | Procedure or surgery | Early transjugular intrahepatic portosystemic shunt (TIPS) |
Primary outcome
Rates of technical success
Time frame: 3 months
Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS.
5 secondary outcomes
Rates of gastrointestinal hemorrhage
Time frame: 6 months
Progression-Free-Survival (PFS)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Objective response rate (ORR)
Time frame: 12 months
Adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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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.
Feng Duan, MD study director
Chinese PLA General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early TIPS in people with Advanced Hepatocellular Carcinoma and Variceal Bleeding, run by Sun Yat-sen University at 2 sites 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 11 inclusion and 7 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 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Qunfang Zhou, MD (86 19868000115, zhouqun988509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of technical success (time frame: 3 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 2 Oct 2024.