Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffu… (NCT06233981) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis
China30 participantsStarted 2024-01-25
Plain-language summary
This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Tislelizumab at a dose of 200mg. Subsequently, Tislelizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Tislelizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity.
Who can participate
Age range
18 Years – 90 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
. Clinical or histological diagnosis of HCC with bilateral PVTT;
. Estimated Liver-GTV volume \< 700ml or the estimated volume of liver minus GTV volume receiving less than 5 Gy of irradiation \< 300ml;
. Age 18-90 years;
. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
. Child-Pugh A5, A6, B7 and B8;
. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times upper limit of normal (ULN); or ALT ≤ 1.5 times ULN and AST ≤ 6 times ULN; TBIL \< 60umol/L.
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.
What they're measuring
1
Median Overall Survival
Timeframe: 24 months
Trial details
NCT IDNCT06233981
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. Hb ≥ 50g/L, ANC ≥ 0.5 × 109/L, PLT ≥ 30 × 109 /L; patients with a history of gastrointestinal bleeding must be controlled for more than 2 weeks before enrollment with Hb ≥ 60g/L;
Exclusion criteria
. Participating in other clinical trials currently;
. The history of abdominal irradiation;
. The history of liver transplantation;
. Known allergy to tislelizumab or lenvatinib;
. Pregnant, breast feeding, or unwilling to use adequate contraception;
. Serious myocardial disease or renal failure;
. Other serious diseases, such as alcohol and drug abuse or mental illness;
. Presence of other life-threatening malignancy within the last 3 years before enrollment (excluding superficial skin cancer, localized low-grade malignant tumor and carcinoma in situ).