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 range18 Years
SexALL
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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:
✓. 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).
What they're measuring
1
1-year RFS
Timeframe: 1 year after surgery
Trial details
NCT IDNCT07518706
SponsorTianjin Medical University Cancer Institute and Hospital
✕. 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: