Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin (NCT07518706) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin
60 participantsStarted 2026-04-30
Plain-language summary
Postoperative recurrence remains a major limitation to long-term survival in hepatocellular carcinoma (HCC). In addition, a narrow surgical margin is widely regarded as a risk factor for recurrence. Neoadjuvant therapy may represent a strategy to reduce the risk of recurrence, thereby improving long-term outcomes. Tislelizumab plus lenvatinib has demonstrated promising efficacy with manageable safety in advanced HCC. Therefore, we will conduct a phase II study to compare neoadjuvant tislelizumab plus lenvatinib followed by surgery versus surgery alone in patients with stage IA HCC and an anticipated narrow surgical margin.
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
. The patient voluntarily participates in this study and provides written informed consent.
. Age ≥18 years at the time of consent; male or female.
. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
. Child-Pugh class A hepatic function.
. Histologically/cytologically confirmed, or clinically diagnosed according to accepted diagnostic criteria, primary hepatocellular carcinoma (HCC), with a single tumor measuring 2-5 cm in greatest diameter (CNLC stage IA).
. At enrollment, the lesion meets the criteria for surgically resectable disease per the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition); and an anticipated narrow surgical margin (resection margin \<1 cm) is expected due to tumor size and/or location, including any of the following:
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
1-year RFS
Timeframe: 1 year after surgery
Trial details
NCT IDNCT07518706
SponsorTianjin Medical University Cancer Institute and Hospital
. No prior local or systemic antitumor therapy for HCC.
. At least one measurable lesion per RECIST v1.1.
Exclusion criteria
. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; any other active malignancy concurrent with HCC or within the past 5 years, except for definitively treated localized tumors (e.g., basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ).
. Planned or prior solid-organ transplantation or allogeneic bone marrow transplantation (corneal transplantation is allowed).
. Known hypersensitivity to macromolecular protein products, or known allergy to any excipients of tislelizumab.
. Any active autoimmune disease or a history of autoimmune disease.
. Use of immunosuppressive agents, or systemic or absorbable topical corticosteroid therapy for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent), that is ongoing within 2 weeks prior to enrollment.
. Clinically symptomatic ascites or pleural effusion requiring therapeutic paracentesis, thoracentesis, or drainage.
. Uncontrolled clinically significant cardiac symptoms or disease, including: