Hepatocellular carcinoma, combined portal vein tumor thrombosis
Conditions
Interventions
Liver Resection + Lenvatinib + Tislelizumab Group:Surgical Resection Followed by Sequential Lenvatinib and Tislelizumab
TACE + Lenvatinib + Tislelizumab Group:TACE Combined with Lenvatinib and Tislelizumab
Sponsors
Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 70 years inclusive (including both 18 and 70 years old); 2. Clinical diagnosis of Hepatocellular Carcinoma (HCC), conforming to the diagnostic criteria of primary liver cancer treatment guidelines from 2023; 3. Clear tumor thrombus observed through imaging (enhanced MRI or CT), with the thrombus not reaching the main trunk of the portal vein or the contralateral side (Cheng's Type I, II, or Vp1-3); 4. The tumor and tumor thrombus are located within the same liver segment, lobe, or hemiliver and are deemed safely resectable (in patients without cirrhosis, the remaining liver volume must be >30% of the standard liver volume, and in patients with cirrhosis, the remaining liver volume must be >40% of the standard liver volume; postoperative liver function is expected to be compensatory after assessment); 5. No clear distant metastasis; 6. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1; 7. Child-Pugh liver function score of A; 8. Adequate organ and bone marrow function, with laboratory test values within 7 days prior to randomization meeting the following requirements (no administration of any blood components, growth factors, albumin, or other corrective treatments is allowed within 14 days prior to obtaining laboratory tests to meet the conditions): specifically, - Complete blood count: Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=75×10^9/L; Hemoglobin (HGB) >=9.0 g/dL; - Liver function: Total serum bilirubin (TBIL) =50 mL/min (Cockcroft-Gault formula); Urine routine results show urine protein =2+ at baseline urine routine, a 24-hour urine collection should be performed, and the 24-hour urine protein quantification should be =12 weeks; 11. Aware of the study process and willing to participate, signing related informed consent documents. **Note:** The determination of resectability for liver cancer combined with portal vein tumor thrombus: meeting the Child-Pugh liver function score of A, and having a good general condition with an ECOG performance status of 0-1, with the tumor located in one side of the liver, and judged by the surgeon that postoperative liver function can be restored (which can be judged by the remaining liver
Exclusion criteria
Exclusion criteria: 1. Known fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC; 2. History of other malignancies; 3. Tumor thrombus extending beyond the main trunk of the portal vein or to the contralateral portal vein, or combined with hepatic vein tumor thrombus; 4. Combined with multiple intrahepatic metastases or distant metastases; 5. History of esophageal or gastric varices bleeding due to portal hypertension within the past 6 months; known severe (Grade 3) varices from endoscopic examination within the past 3 months; evidence of portal hypertension (including imaging findings such as splenomegaly), with a high risk of bleeding assessed by the investigator; 6. Severe bleeding tendency or coagulation dysfunction, or currently undergoing thrombolytic therapy; 7. Long-term use of medications that can inhibit platelet function, such as aspirin (>325 mg/day), dipyridamole, or clopidogrel, etc.; 8. Uncontrollable hypertension, with systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy; 9. Symptomatic congestive heart failure (New York Heart Association Class II-IV), symptomatic or poorly controlled arrhythmias, history of congenital long QT syndrome, or corrected QTc >500ms (calculated using the Fridericia formula) upon screening; 10. History of gastrointestinal perforation and/or fistula within the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea; 11. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe impaired pulmonary function and other pulmonary diseases; 12. Acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA >2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA >103 copies/mL; positive for both hepatitis B surface antigen (HBsAg) and anti-HCV antibody; 13. Human immunodeficiency virus (HIV) infection (positive for HIV 1/2 antibodies), known syphilis infection; 14. Active or poorly controlled severe infection; 15. Use of immunosuppressive drugs within 4 weeks prior to randomization, excluding intranasal, inhaled, or other topical glucocorticoids or physiologic doses of systemic glucocorticoids (i.e., no more than 10 mg/day of prednisone or equivalent dose of other glucocorticoids), with allowance for temporary use of glucocorticoids for the treatment of dyspnea symptoms due to asthma, chronic obstructive pulmonary disease, and other diseases; 16. History of any anti-angiogenic agents, anti-PD-1 antibodies, anti-PD-L1/L2 antibodies, anti-CTLA-4 antibodies, or other immunotherapies; 17. Pregnant or lactating female patients; 18. Other acute or chronic diseases, mental disorders, or laboratory test abnormalities that may lead to the following outcomes: increased risk associated with study participation or study drug administration, or interference with the interpretation of study results, and as judged by the investigator, disqualify the patient from being eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival(OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival(EFS);Disease-Free Survival (DFS);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactZhou Weiping
Third Affiliated Hospital of Naval Medical University
Outcome results
None listed