Irradiation Stent Placement Plus TACE for HCC and PVTT (NCT03730675) | Clinical Trial Compass
UnknownNot Applicable
Irradiation Stent Placement Plus TACE for HCC and PVTT
China308 participantsStarted 2018-11-10
Plain-language 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. Patients will be randomized to receive either portal irradiation stent placement plus TACE(Arm A) or Sorafenib plus TACE (Arm B).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Child-Pugh class A or B
. Eighteen years of age or older
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. 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.