Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
308 participants
INTERVENTIONAL
2018-11-10
2021-11-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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irradiation stent plus TACE
Portal irradiation stent placement will be performed before TACE procedures.
Portal irradiation stent placement
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
TACE
TACE is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply.
Sorafenib plus TACE
TACE will be performed in patients randomized to Arm B, with sequential sorafenib.
TACE
TACE is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply.
Sorafenib
Sorafenib is a kinase inhibitor drug approved for the treatment of advanced hepatocellular carcinoma.
Interventions
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Portal irradiation stent placement
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
TACE
TACE is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply.
Sorafenib
Sorafenib is a kinase inhibitor drug approved for the treatment of advanced hepatocellular carcinoma.
Eligibility Criteria
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Inclusion Criteria
1. Histologically-confirmed or clinical diagnosis of hepatocellular carcinoma (HCC)
2. Histologically-confirmed or imaging-based diagnosis malignant portal vein tumor thrombosis(PVTT)
3. Portal trunk invaded tumor thrombosis without the infiltration of superior mesenteric vein or inferior caval vein
4. At least one patent first branch of the portal vein
5. Measurable intrahepatic disease according to mRECIST
6. Child-Pugh class A or B
7. Eighteen years of age or older
8. With an expected lifespan more than 3 months
9. ECOG performance status 0, 1 or 2
10. 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
Exclusion Criteria
2. Less than 30% volume of uninvolved liver
3. 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)
4. Presence of clinically relevant ascites (that can be classified as Child-Pugh score of 3).
5. Documented variceal hemorrhage within 6 months of study entry or presence of esophageal varices at risk of bleeding (as documented by endoscopy/CT/fluoroscopy)
6. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study entry
7. 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.
8. 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.
9. Hypertension that cannot be controlled by medications (blood pressure \>150/100 mm Hg despite optimal medical therapy).
10. Concomitant treatment with botanical formulation having an approved indication for cancer treatment, such as "Xiao Chai Hu Tang", "Kanglaite", "Huai Er Ke Li"etc.
11. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
12. 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.
13. 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.
18 Years
ALL
No
Sponsors
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Zhongda Hospital
OTHER
Responsible Party
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Gao-jun Teng
President
Principal Investigators
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Gao-Jun Teng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Locations
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Zhong-da Hospital, Southeast University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Jian Lu, MD
Role: primary
References
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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.
Other Identifiers
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ZhongdaH-PATENCY
Identifier Type: -
Identifier Source: org_study_id