Primary hepatic carcinoma
Conditions
Interventions
Experimental group:HAIC(hepatic artery infusion chemotherapy) combined with Lenvatinib
Sponsors
The Third Affiliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, no gender limitation; 2. Hepatocellular carcinoma (HCC) was diagnosed clinically or histopathologically (in accordance with the 2017 edition of Primary Liver Cancer Diagnosis and Treatment Guidelines); 3. Patients with HCC beyond Milan criteria with portal vein thrombosis were classified as Cheng's type I and II, without portal vein thrombosis, hepatic vein thrombosis or extrahepatic metastasis (Multidisciplinary diagnosis and treatment of hepatocellular carcinoma with portal vein thrombosis: Chinese Expert Consensus 2018 edition, Chinese Journal of Practical Surgery, 2019); 4. No history of systematic treatment; 5. No local treatment history (intervention, ablation, iodine particle therapy, radiotherapy, etc.), or tumor survival after local treatment, less than 3 times, the last treatment at least 1 month; 6. The expected survival time is more than 3 months; 7. Good liver function: Child-Pugh grade A or B (= 1.5 x 10^9/L; platelet >= 50 x 10^9/L; hemoglobin >= 9 g/dL; serum albumin >= 2.8 g/dL; (2) Thyroid stimulating hormone (TSH) <= 1 x ULN (if abnormal, T3 and T4 levels should be investigated simultaneously; if T3 and T4 levels are normal, they can be included in the group); (3) Bilirubin <= 1.5 x ULN; ALT and AST <= 3 x ULN; (4) Serum creatinine <= 1.5 x ULN; 9. Physical ECOG 0-1 points; 10. To understand and sign informed consent, must be willing and able to comply with visits, treatment protocols, laboratory tests, and other requirements of the study as specified in the study schedule.
Exclusion criteria
Exclusion criteria: 1. There are large vessel cancer thrombus (portal vein trunk/hepatic vein tumor thrombus/inferior vena cava tumor thrombus);Regional lymph node metastasis or extrahepatic metastasis; 2. Allergy to oxaliplatin, calcium folinate, 5-fluorouracil; ramvaratinib allergy; 3. Those who have suffered from or are complicated with other malignant tumors; 4. There is active tuberculosis infection. Patients with active TB infection within 1 year prior to medication, even if treated, should be excluded; patients with a history of active TB infection more than 1 year ago should also be excluded, unless previous standard anti-tb therapy is demonstrated; 5. Have an active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilators). Subjects receiving hormone replacement therapy only for hypothyroidism and skin conditions that do not require systemic treatment (such as vitiligo, psoriasis or hair loss) may be selected; 6. Previous interstitial lung disease or (non-infectious) pneumonia requiring oral or intravenous steroid therapy; 7. Long-term treatment with systemic sex hormones (equivalent to a dose of > 10 mg prednisone/day) or any other form of immunosuppressive therapy is required. Subjects using inhaled or topical corticosteroids may be selected; 8. Patients with grade II or above myocardial ischemia or myocardial infarction, hypertension, which cannot be reduced to the normal range by drug treatment (systolic blood pressure > 140 mmHg, diastolic pressure > 90 mmHg); 9. Abnormal coagulation function (PT > 18s, APTT > 43s, TT > 21s, Fbg < 2 g/L), had a history of gastrointestinal bleeding within 6 months, had obvious bleeding tendency or was receiving thrombolytic or anticoagulant therapy; 10. Pregnant or lactating women; 11. Clinical trials involving other investigational drugs within 4 weeks; 12. Active infections requiring systemic treatment; 13. Human immunodeficiency virus positive; 14. Other factors that may affect the subject's safety or test compliance as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Routine blood test;Abdominal CT/MR scan;Liver function;Renal function;Coagulation function (PT, APTT, FIB, INR, TT);AFP;Hepatitis B virus five;HBV-DNA;Abdominal CT scan;EFS(event-free survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum electrolyte;GLU;Routine urine test;Stool occult blood;ECG;Chest CT scan;Pelvic cavity CT scan;Head CT scan;Bone scanning;Stool routine examination;CEA;CA-125;CA-199;SF;TPSA;IL-6;IFN;HIV;HCV-RNA;Ultrasound cardiogram;OS(overall survival);RFS(recurrence free survival);Liver transplant drop-out rate;ORR(Objective Response Rate);DCR(Disease Control Rate); | — |
Countries
China
Contacts
Public ContactDeng Yi'nan
The Third Affiliated Hospital of Sun Yat-Sen University
Outcome results
None listed