Hepatocellular CarcinomaNCT03730675
Irradiation Stent Placement Plus TACE for HCC and PVTT
A study testing Portal irradiation stent placement, TACE and Sorafenib in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombosis, run by Zhongda Hospital at 1 site in China.
Trial summary
The study is a multicenter, randomized (1:1), open-label, parallel-arm, Phase 3 clinical trial to evaluate the efficacy and safety of portal irradiation stent placement plus TACE compared to sorafenib plus TACE in patients with advanced HCC accompanied by portal vein tumor thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Portal Vein Tumor Thrombosis
- What is being tested?
- Portal irradiation stent placement, TACE and Sorafenib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 10 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •
- Histologically-confirmed or clinical diagnosis of hepatocellular carcinoma (HCC)
- Histologically-confirmed or imaging-based diagnosis malignant portal vein tumor thrombosis(PVTT)
- Portal trunk invaded tumor thrombosis without the infiltration of superior mesenteric vein or inferior caval vein
- At least one patent first branch of the portal vein
- Measurable intrahepatic disease according to mRECIST
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- Child-Pugh class A or B
- Eighteen years of age or older
- With an expected lifespan more than 3 months
- ECOG performance status 0, 1 or 2
- Required baseline laboratory data within the following parameters:
- 1. Neutrophils ≥ 1.0×10⁹/L 2. Platelets ≥ 50×10⁹ /L 3. Hemoglobin ≥ 90 g/L 4. Serum aspartate aminotransferase (AST; ALT≤5 x ULN) 5. Serum creatinine ≤1.5 x ULN 6. INR <1.7 or prothrombin time (PT) < 4 seconds above ULN 7. Total bilirubin < 34.2 umol/L(2 mg/dL) 11. Signed and dated informed consent and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Who cannot join
- Presence of distant metastasis outside liver or diagnosis of any second malignancy beyond HCC
- Less than 30% volume of uninvolved liver
- Prior systemic treatment, including prior treatment with sorafenib or any prior local therapy (such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection or cry ablation)
- Presence of clinically relevant ascites (that can be classified as Child-Pugh score of 3).
- Documented variceal hemorrhage within 6 months of study entry or presence of esophageal varices at risk of bleeding (as documented by endoscopy/CT/fluoroscopy)
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study entry
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- Any of the following within the 3 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade≥2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females.
- Hypertension that cannot be controlled by medications (blood pressure >150/100 mm Hg despite optimal medical therapy).
- Concomitant treatment with botanical formulation having an approved indication for cancer treatment, such as "Xiao Chai Hu Tang", "Kanglaite", "Huai Er Ke Li"etc.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to study enrollment.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhong-da Hospital, Southeast University
Nanjing, Jiangsu, 210009
Jian Lu, MD
About this study
Official title: Irradiation Stent Placement Plus Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: A Multicenter Randomized Study
The study is a multicenter, randomized (1:1), open-label, parallel-arm, Phase 3 clinical trial to evaluate the efficacy and safety of portal irradiation stent placement plus TACE compared to sorafenib plus TACE in patients with advanced HCC accompanied by portal vein tumor thrombosis. Patients will be randomized to receive either portal irradiation stent placement plus TACE(Arm A) or Sorafenib plus TACE (Arm B).
Read the detailed description
The prognosis of HCC with portal vein tumor thrombosis (PVTT) is dismal, with a median survival of 2.7-4.0 months compared to that of 10.0-24.0 months without PVTT. Therefore, the presence of PVTT is regarded as a hallmark of advanced HCC and has a high incidence of 39-63%.
PVTT can accompany intrahepatic tumor spread, liver function deterioration, and portal vein hypertension, and can lead to intractable ascites, variceal rupture, hepatic encephalopathy and/or death. As recommended by the Barcelona Clinic Liver Cancer (BCLC) group, the current standard treatment of HCC with PVTT is sorafenib only. However, sorafenib monotherapy does not achieve satisfactory outcomes, yielding a median survival time of 5.6 to 8.1 months. To improve the prognosis, transarterial chemoembolization (TACE), surgical resection, radiotherapy, ablations, and radioembolization have been applied to treat patients with HCC and PVTT, with improved outcomes reported.
Portal vein stent placement is regarded as a safe and effective technique in relieving portal hypertension, extending treatment options, and prolonging survival in patients with HCC and PVTT. However, the reported stent patency period of 3.7 months and survival time of 2.2 to 6.1 months may not be interpreted as satisfactory outcomes, mainly limited by rapid tumor infiltration and/or subsequent thrombosis formation.
An irradiation stent has been developed and confirmed to be safe and effective in treating unresectable esophageal cancer. A modified irradiation stent designed for biliary tract obstruction was subsequently developed and resulted in significantly improved outcomes in a single-institute randomized, controlled study of patients with malignant biliary obstruction. This study aims to demonstrate that overall survival on portal irradiation stent placement plus TACE is superior to overall survival on sorafenib plus TACE in patients with advanced hepatocellular carcinoma accompanied by portal vein tumor thrombosis. Secondary Objectives includes 1. To compare time to progression between both treatment groups; 2. To compare hepatic function between both treatment groups; 3.To compare the disease control rate of the intrahepatic lesions between both treatment groups; 4.To evaluate and compare the safety and tolerability of both treatment groups; 5. To compare portal patency both treatment groups.
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portal irradiation stent placementProcedure or surgery
The irradiation portal vein stent was designed as two separate parts that consisted of an outer seeds-loaded-stent and an inner self-expandable metallic stent
TACEProcedure or surgery
TACE is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply.
SorafenibDrug
Sorafenib is a kinase inhibitor drug approved for the treatment of advanced hepatocellular carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| irradiation stent plus TACE | Experimental | Portal irradiation stent placement will be performed before TACE procedures. Receives: Procedure: Portal irradiation stent placement; Procedure: TACE |
| Sorafenib plus TACE | Active comparator | TACE will be performed in patients randomized to Arm B, with sequential sorafenib. Receives: Procedure: TACE; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival was measured from the date of randomization until the date of death from any cause.
Measured: up to 36 months
Secondary outcomes (5)
Hepatic function in terms of albumin and total bilirubin
Hepatic function was measured in terms of albumin and total bilirubin.
Measured: up to 36 months
Time to symptomatic progression
The time to symptomatic progression was measured from the date of randomization until the first documented event of symptomatic progression. Symptomatic progression was defined as a deterioration in ECOG performance status to 4 or death
Measured: up to 36 months
Patency of portal vein
Patency of portal vein was evaluated by color doppler ultrasound
Measured: up to 36 months
Disease control rate of intrahepatic lesions
Disease control rate of intrahepatic lesions referred to percentage of patients who had complete response, partial response, or stable disease.
Measured: up to 36 months
Treatment Safety in terms of type, incidence, severity timing, seriousness, and relatedness of adverse events and laboratory abnormalities
Safety was evaluated in terms of type, incidence, severity (graded by the Common Terminology Criteria for Adverse Events [CTCAE], version 4.02), timing, seriousness, and relatedness of adverse events and laboratory abnormalities.
Measured: 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 posted5 Nov 2018
- Study start10 Nov 2018
- Primary completion10 Nov 2021 (estimated)
- Study completion10 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, M.D., Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730675
- Sponsor's protocol ID
- ZhongdaH-PATENCY
- Status last verified
- Dec 2018
- First submitted
- 28 Oct 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu J, Guo JH, Ji JS, Li YL, Lv WF, Zhu HD, Sun JH, Ren WX, Zhang FJ, Wang WD, Shao HB, Cao GS, Li HL, Gao K, Yang P, Yin GW, Zhu GY, Wu FZ, Wang WJ, Lu D, Chen SQ, Min J, Zhao Y, Li R, Lu LG, Lau WY, Teng GJ. Irradiation stent with 125 I plus TACE versus sorafenib plus TACE for hepatocellular carcinoma with major portal vein tumor thrombosis: a multicenter randomized trial. Int J Surg. 2023 May 1;109(5):1188-1198. doi: 10.1097/JS9.0000000000000295.
PubMed 37038986
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irradiation Stent Placement Plus Transcatheter Arterial Chemoembolization in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: A Multicenter Randomized Study
- ClinicalTrials.gov ID
- NCT03730675
- Acronym / sponsor ID
- ZhongdaH-PATENCY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 10 Nov 2021 (estimated)
- Study completion
- 10 Nov 2021 (estimated)
- First posted
- 5 Nov 2018 (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 study is a multicenter, randomized (1:1), open-label, parallel-arm, Phase 3 clinical trial to evaluate the efficacy and safety of portal irradiation stent placement plus TACE compared to sorafenib plus TACE in patients with advanced HCC accompanied by portal vein tumor thrombosis. Patients will be randomized to receive either portal irradiation stent placement plus TACE(Arm A) or Sorafenib plus TACE (Arm B).
Detailed description
The prognosis of HCC with portal vein tumor thrombosis (PVTT) is dismal, with a median survival of 2.7-4.0 months compared to that of 10.0-24.0 months without PVTT. Therefore, the presence of PVTT is regarded as a hallmark of advanced HCC and has a high incidence of 39-63%.
PVTT can accompany intrahepatic tumor spread, liver function deterioration, and portal vein hypertension, and can lead to intractable ascites, variceal rupture, hepatic encephalopathy and/or death. As recommended by the Barcelona Clinic Liver Cancer (BCLC) group, the current standard treatment of HCC with PVTT is sorafenib only. However, sorafenib monotherapy does not achieve satisfactory outcomes, yielding a median survival time of 5.6 to 8.1 months. To improve the prognosis, transarterial chemoembolization (TACE), surgical resection, radiotherapy, ablations, and radioembolization have been applied to treat patients with HCC and PVTT, with improved outcomes reported.
Portal vein stent placement is regarded as a safe and effective technique in relieving portal hypertension, extending treatment options, and prolonging survival in patients with HCC and PVTT. However, the reported stent patency period of 3.7 months and survival time of 2.2 to 6.1 months may not be interpreted as satisfactory outcomes, mainly limited by rapid tumor infiltration and/or subsequent thrombosis formation.
An irradiation stent has been developed and confirmed to be safe and effective in treating unresectable esophageal cancer. A modified irradiation stent designed for biliary tract obstruction was subsequently developed and resulted in significantly improved outcomes in a single-institute randomized, controlled study of patients with malignant biliary obstruction. This study aims to demonstrate that overall survival on portal irradiation stent placement plus TACE is superior to overall survival on sorafenib plus TACE in patients with advanced hepatocellular carcinoma accompanied by portal vein tumor thrombosis. Secondary Objectives includes 1. To compare time to progression between both treatment groups; 2. To compare hepatic function between both treatment groups; 3.To compare the disease control rate of the intrahepatic lesions between both treatment groups; 4.To evaluate and compare the safety and tolerability of both treatment groups; 5. To compare portal patency both treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| irradiation stent plus TACE | Experimental | Procedure: Portal irradiation stent placement, Procedure: TACEPortal irradiation stent placement will be performed before TACE procedures. |
| Sorafenib plus TACE | Active comparator | Procedure: TACE, Drug: SorafenibTACE will be performed in patients randomized to Arm B, with sequential sorafenib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- •
- 1. Neutrophils ≥ 1.0×10⁹/L 2. Platelets ≥ 50×10⁹ /L 3. Hemoglobin ≥ 90 g/L 4. Serum aspartate aminotransferase (AST; ALT≤5 x ULN) 5. Serum creatinine ≤1.5 x ULN 6. INR <1.7 or prothrombin time (PT) < 4 seconds above ULN 7. Total bilirubin < 34.2 umol/L(2 mg/dL) 11. Signed and dated informed consent and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Key exclusion criteria (13 listed)
- Presence of distant metastasis outside liver or diagnosis of any second malignancy beyond HCC
- Less than 30% volume of uninvolved liver
- Prior systemic treatment, including prior treatment with sorafenib or any prior local therapy (such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection or cry ablation)
- Presence of clinically relevant ascites (that can be classified as Child-Pugh score of 3).
- Documented variceal hemorrhage within 6 months of study entry or presence of esophageal varices at risk of bleeding (as documented by endoscopy/CT/fluoroscopy)
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 |
|---|---|---|
| Portal irradiation stent placementThe irradiation portal vein stent was designed as two separate parts that consisted of an outer seeds-loaded-stent and an inner self-expandable metallic stent | Procedure or surgery | irradiation stent plus TACE |
| TACETACE is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply. | Procedure or surgery | Sorafenib plus TACE, irradiation stent plus TACE |
| SorafenibSorafenib is a kinase inhibitor drug approved for the treatment of advanced hepatocellular carcinoma. | Drug | Sorafenib plus TACE |
Primary outcome
Overall survival
Time frame: up to 36 months
Overall survival was measured from the date of randomization until the date of death from any cause.
5 secondary outcomes
Hepatic function in terms of albumin and total bilirubin
Time frame: up to 36 months
Time to symptomatic progression
Time frame: up to 36 months
Patency of portal vein
Time frame: up to 36 months
Disease control rate of intrahepatic lesions
Time frame: up to 36 months
Treatment Safety in terms of type, incidence, severity timing, seriousness, and relatedness of adverse events and laboratory abnormalities
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
- Derived from this study: PubMed 37038986Lu J, Guo JH, Ji JS, Li YL, Lv WF, Zhu HD, Sun JH, Ren WX, Zhang FJ, Wang WD, Shao HB, Cao GS, Li HL, Gao K, Yang P, Yin GW, Zhu GY, Wu FZ, Wang WJ, Lu D, Chen SQ, Min J, Zhao Y, Li R, Lu LG, Lau WY, Teng GJ. Irradiation stent with 125 I plus TACE versus sorafenib plus TACE for hepatocellular carcinoma with major portal vein tumor thrombosis: a multicenter randomized trial. Int J Surg. 2023 May 1;109(5):1188-1198. doi: 10.1097/JS9.0000000000000295.
- Individual participant dataSharing planned: No
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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.
Gao-Jun Teng, M.D. principal investigator
Zhongda 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 Portal irradiation stent placement, TACE and Sorafenib in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombosis, run by Zhongda 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 12 inclusion and 13 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 21 Dec 2018. 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 Jian Lu, M.D. (86+15850654644, lujian43307131@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03730675, which also lists 1 linked publication.
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 21 Dec 2018.