Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A … (NCT06031285) | Clinical Trial Compass
RecruitingPhase 2
Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A Phase-2 Clinical Trial
China43 participantsStarted 2023-09-01
Plain-language summary
Although resection provided survival benefit for selected HCC patients with PVTT, the recurrence rate is still high for those patients. It is still unknown whether perioperative Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the survival for those patients. We initialed this phase 2 clinical trial to prove the perioperative therapy.
Who can participate
Age range
18 Years – 75 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:
* Clinically diagnosed or pathologically confirmed resectable advanced hepatocellular carcinoma, at least one measurable focus without local treatment (according to mRECIST requirements);
* Child-Pugh score ≤ 6 points (Child-Pugh A);
* BCLC staging is stage C; PVTT classification is combined with PVTT (VP1-2), and a single lesion in the liver (or multiple lesions with diameter) ≤ 10cm of primary liver cancer.
* Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past;
* ECOG score: 0～1 (see Annex 1 for ECOG scoring criteria);
* Expected survival period ≥ 12 weeks;
* The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration):
Exclusion Criteria:
* The patient has any active autoimmune disease or a history of autoimmune disease;
* The patient is using systemic therapy or local treatment for HCC before enrollment;
* Severe allergic reaction to other monoclonal antibodies;
* Those with a known history of central nervous system metastasis or hepatic encephalopathy;
* Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past;
* Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except those who have only a small amount of a…
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.