Toripalimab in Combination With Lenvatinib and TACE for Conversion Therapy in Patients With Poten… (NCT05056337) | Clinical Trial Compass
UnknownPhase 3
Toripalimab in Combination With Lenvatinib and TACE for Conversion Therapy in Patients With Potentially Resectable HCC
China220 participantsStarted 2021-08-01
Plain-language summary
Study introduction: this is a multicenter, randomized controlled study of patients with histopathologically confirmed hepatocellular carcinoma (HCC) who have not previously received systematic treatment for HCC, all the patients are Chinese stage IIb/IIIa (BCLC stage B/C), and have not developed extrahepatic metastases. Follow-up, data collection and analysis will be performed for patients who meet the study inclusion criteria and will be treated with lenvatinib plus toripalimab and TACE (on demand) or TACE alone, so as to compare the objective response rate (ORR), overall survival (OS), progression-free survival (PFS), ratio of conversion resection, and safety between the two cohorts.
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
. Male or female patients of 18-75 years old;
. Clinical or histopathological diagnosis of hepatocellular carcinoma;
. ECOG PS score of 0-1, Child-Pugh grade A;
. Chinese stage IIb/IIIa (equal to BCLC B/C) patients with portal vein tumor thrombus (according to the Japanese PVTT grading criteria Vp3-Vp4) or more than 3 tumor nodules, without extrahepatic metastasis;
. According to the evaluation by the site multi-disciplinary team (MDT), surgical resection is not the current preferred treatment;
. No previous systemic treatment for hepatocellular carcinoma; no previous use of PD-1 inhibitor, PD-L1 inhibitor, lenvatinib or sorafenib;
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.
What they're measuring
1
Tumor response: Objective response rate (assessed based on mRECIST criteria)
. The patients in the treatment group voluntarily and have decided to receive treatment of lenvatinib in combination with toripalimab and TACE, and sign an informed consent form. Additional identification of qualified subjects: subjects who have received at least one combination medication enter the safety evaluation; subjects who have received at least one imaging evaluation after treatment enter the efficacy evaluation. The patients in the control group treated with TACE alone have at least one imaging evaluation.
Exclusion criteria
. Clinical or pathological diagnosis of mixed liver cancer, fibrolamellar hepatocellular carcinoma or other non-hepatocellular malignant tumor components;
. Hematological examination: PLT\<50×109/L, WBC\<3.0×109/L or not meet the requirements of TACE treatment;
. Coagulation function: international normalized (prothrombin time) ratio (INR) \> 1.2;
. Liver function indicators: serum albumin (ALB) \< 2.8 g/dl, serum total bilirubin (TBIL) \> 1.5 times the upper limit of normal (excluding those with biliary obstruction), serum transaminase (ALT and AST) \> 3 times the upper limit of normal;
. Renal function indicators: serum creatinine (CR) \> 1.5 times the upper limit of normal;
. Uncontrollable hypertension (defined as diastolic blood pressure \> 90 mmHg or systolic blood pressure \> 150 mmHg);
. Patients with bile duct tumor thrombi, superior mesenteric vein tumor thrombi and diffuse portal vein tumor thrombi;
. Participated in other clinical trials 30 days before screening;