Following collective deliberation by the hepatobiliary surgery expert panel, it is determined that patients with CNLC stage Ia to IIIa hepatocellular carcinoma who are suitable for surgical resection but present a high risk of postoperative recurrence and metastasis
Conditions
Interventions
Single-Arm:Preoperative neoadjuvant hepatic arterial infusion chemotherapy - hepatic arterial embolization chemotherapy combined with lenvatinib and camrelizumab treatment
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years, male or female; 2. ECOG PS score =1500/µL; 1) Platelets >=60,000/µL; 2) Hemoglobin >8.5 g/dL; 3) ALT and AST <5 times the upper limit of normal; 4) Serum creatinine <1.5 times the upper limit of normal. 9. Patients are aware of their condition and have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous receipt of any anti-hepatocellular carcinoma (HCC) therapy (traditional Chinese medicine or preparations thereof shall not be considered); 2. Presence of diffuse tumor thrombus involving the main portal vein or its left and right branches, inferior vena cava tumor thrombus, or tumor invasion into the bile ducts with biliary tract tumor thrombus formation; 3. Diffuse hepatocellular carcinoma; 4. Allergy to contrast agents; 5. History of heart disease or uncontrolled hypertension (>150/100 mmHg); 6. History of thrombotic disease or gastrointestinal bleeding within the past 6 months; 7. Active infection other than HBV/HCV exceeding grade 2 according to CTCAE version 5.0 criteria, or other severe comorbidities that preclude tolerance of treatment; 8. History of other malignant neoplasms; 9. Known hypersensitivity to relevant study drugs; 10. History of organ transplantation; 11. Pregnant or lactating women; 12. Use of immunosuppressants or systemic corticosteroids for the purpose of immunosuppression within 14 days prior to initiation of investigational treatment (dose >10 mg/day prednisone or equivalent); 13. Presence of active autoimmune disease or history of autoimmune disease with potential for relapse (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism [subjects whose hypothyroidism is controlled solely by hormone replacement therapy may be enrolled]); subjects with dermatological conditions not requiring systemic therapy such as vitiligo, psoriasis, or alopecia; patients with type 1 diabetes mellitus managed with insulin; or those with childhood asthma that has been fully resolved and requires no intervention in adulthood may be enrolled; however, patients with asthma requiring bronchodilators for medical management are ineligible; 14. Other factors that may affect subject enrollment or assessment of outcomes; 15. Subjects judged by the investigator to have poor compliance and unable to adhere to the study protocol regarding treatment and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Recurrence-Free Survival (RFS);Pathological Response Rate;Surgical Resection Rate; | — |
Countries
China
Contacts
Public ContactJin Haosheng
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed