Status:
UNKNOWN
A Clinical Study of Tislelizumab Combined With TACE and Lenvatinib in the Neoadjuvant Treatment of Resectable HCC
Lead Sponsor:
First Affiliated Hospital of Fujian Medical University
Conditions:
Hepatocellular Carcinoma Resectable
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
In order to improve the R0 resection rate, reduce distant metastasis, and lower postoperative recurrence, there is a growing exploration of surgical treatments for hepatocellular carcinoma (HCC), incl...
Detailed Description
1. Background Primary liver cancer is one of the most common malignancies worldwide, ranking sixth in terms of incidence and third in terms of cancer-related mortality. Hepatocellular carcinoma (H...
Eligibility Criteria
Inclusion
- Participants must voluntarily enroll in this study and provide signed informed consent.
- Male or female patients between the ages of 18 and 75 years old.
- Patients diagnosed with hepatocellular carcinoma (HCC) confirmed by histopathology or imaging.
- Chinese liver cancer staging of IIa-IIb with hepatocellular carcinoma considered resectable by the investigator. For IIa-stage patients, they must meet at least one of the following criteria: unclear tumor margins, proximity to blood vessels, or suspicious residual margins.
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) guidelines (measurable lesions with CT scan long diameter ≥ 10 mm or lymph node lesions with CT scan short diameter ≥ 15 mm, and no prior local treatment such as radiation or cryotherapy).
- Child-Pugh liver function class A.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- No prior systemic treatment for HCC.
- For HBsAg-positive patients, HBV-DNA \< 200,000 IU/ml (106 copies/ml), and receiving routine antiviral therapy.
- Expected survival of at least 3 months.
- Normal major organ function, meeting the following criteria:
- Hematology criteria:
- Hemoglobin (HB) ≥ 90 g/L;
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/m3);
- Platelet count (PLT) ≥ 75 × 109/L.
- Biochemistry criteria:
- Total bilirubin (TBIL) ≤ 2 × ULN;
- ALT, ALP, and AST ≤ 5 × ULN;
- Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 ml/min (calculated using the Cockcroft-Gault formula: CrCL (mL/min) = \[(140 - age) × body weight (kg) × F\] / (SCr(mg/dL) × 72). Where F=1 for males and F=0.85 for females; SCr=serum creatinine).
- Coagulation function: International Normalized Ratio (INR) ≤ 2.3.
- Blood pressure (BP) controlled with a maximum of 3 antihypertensive medications, defined as BP ≤ 150/90 mmHg at screening, and no changes in antihypertensive treatment within one week before Cycle 1/Day 1.
- Doppler echocardiography: Left Ventricular Ejection Fraction (LVEF) ≥ lower limit of normal (50%).
- Women of childbearing potential must use reliable contraceptive methods or undergo pregnancy testing (serum or urine) within 7 days before enrollment, with negative results, and agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of investigational drugs. For males, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of investigational drugs or have undergone surgical sterilization.
Exclusion
- Extrahepatic metastasis of primary liver cancer.
- Diffuse liver cancer with tumor burden ≥ 50% of liver volume; and/or macrovascular invasion of the portal vein classified as Type IV; and/or inferior vena cava tumor thrombosis.
- Prior treatment with targeted immunotherapy agents, including but not limited to anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA-4) antibodies.
- Contraindications for Transarterial Chemoembolization (TACE) treatment.
- Participation in other investigational drug trials within the past 4 weeks.
- Medical history and comorbidities:1)Active, known, or suspected autoimmune diseases, including a history of allogeneic organ transplantation, allogeneic hematopoietic stem cell transplantation, HIV positive history, or acquired immunodeficiency syndrome (AIDS) history. 2)Severe cardiovascular diseases: Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; NYHA Class III-IV heart failure, or left ventricular ejection fraction (LVEF) \< 50% based on echocardiography. 3)Active infections. 4)Known allergies to components of Tislelizumab or Lenvatinib. 5)History of substance abuse, alcoholism, or drug addiction.
- Ineligibility as determined by the investigator.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06003673
Start Date
July 1 2023
End Date
July 1 2025
Last Update
October 24 2023
Active Locations (1)
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1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350000