Advanced Hepatocellular Carcinoma with VP3-VP4 Portal vein tumor thrombosis
Conditions
Interventions
Treatment group:HAIC Synchronized Portal Vein Tumor Thrombosis SBRT Combined with TKIs and PD-1 Inhibitors
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years and =75 years; (2) Hepatocellular carcinoma that meets the clinical diagnostic criteria of China's Guidelines for the Diagnosis and Treatment of Primary Hepatocellular Carcinoma (2022 Edition), or is confirmed by histology/cytology; (3) Measurable lesions meeting mRECIST or RECIST 1.1 criteria on baseline imaging; (4) Hepatocellular carcinoma patients with primary treatment or recurrence after previous radical treatment such as surgical resection or radical ablation, and without local or systemic systemic antitumor therapy; (5) Patients with combined VP3-VP4 type portal vein tumor thrombosis confirmed by imaging; (6) Liver function graded as Child-Pugh score = 7; (7) ECOG PS score =1; (8) Expected survival =3 months; (9) Laboratory test values within 7 days prior to enrollment meet the following requirements: a) white blood cell count = 3.0×10^9/L; b) neutrophil count = 1.5×10^9/L; c) platelet count = 75×10^9/L; d) hemoglobin level = 90.0 g/L; e) serum total bilirubin (TBIL) = 2×ULN; f) alanine aminotransferase ( f) alanine aminotransferase (ALT) = 5×ULN; g) aspartate aminotransferase (AST) = 5×ULN; h) serum creatinine (Cr) = 1.5×ULN or creatinine clearance (CCr) = 50 mL/min (Cockcroft-Gault formula); i) urine routine results show urinary proteins < 2+; for patients with urinary proteins = 2+ in the urine routine test at baseline, a 24-hour urine collection should be performed and the patient should have the following results: (i) urine protein < 2+; for patients with urinary protein = 2+ at baseline, a 24-hour urine collection should be performed. A 24-hour urine collection should be performed with a 24-hour urine protein quantification of <1g; j) International Normalized Ratio (INR) or Activated Partial Thromboplastin Time (APTT) = 1.5 times ULN; (10) Women of childbearing potential must have had a negative pregnancy test (serum) within 7 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 8 weeks after the final administration of the test drug; for men, should be surgically sterilized or agree to use an appropriate method of contraception for the duration of the trial and for 8 weeks after the final administration of the test drug; (11) In the case of subjects with HBV or HCV infection, the following criteria must be met: a) HBV-infected subjects (HbsAg- or HBV-DNA-positive): HBV-infected subjects should have received guideline-recommended antiviral therapy for at least 3 days prior to the first treatment dose and have had a decrease in HBV-DNA on retest or have a decrease of HBV-DNA <2,000 IU/ml in the 28 days prior to the first administration of study medication. 2000 IU/ml. Regulated antiviral therapy must be continued during the study period. b) HCV-infected subjects (HCV-Ab or HCV-RNA positive): in a stable state as judged by the investigator, and should continue to receive antiviral therapy during the study period if ongoing. c) HCV-infected subjects: in a stable state as judged by the investigator. d) HCV-infected subjects: in a stable state as judged by the investigator; (12) Subjects voluntarily enroll in the study, sign an informed consent form, are compliant and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: (1) Patients with a known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation; (2) Presence of any active autoimmune disease or history of autoimmune disease; (3) Human immunodeficiency virus (HIV) infected patients (HIV 1/2 antibody positive); (4) Previous diagnosis of any other malignant tumor (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or radically resected carcinoma in situ); (5) Any life-threatening bleeding event within 6 months prior to enrollment; (6) Arterial or venous thromboembolic events within 6 months prior to enrollment; (7) Presence of high bleeding risk, including: a) major trauma or major surgery within 30 days prior to enrollment; b) presence of any bleeding disorders, such as hemophilia, vascular hemophilia, etc.; and c) undergoing thrombolytic therapy, anticoagulation therapy, or antiplatelet therapy, etc; (8) Symptomatic congestive heart failure (New York Heart Association classification II-IV), symptomatic or poorly controlled arrhythmias, history of congenital long QT syndrome or corrected QTc > 500ms at screening, uncontrollable hypertension or history of hypertensive crisis or hypertensive encephalopathy; (9) Past and current pulmonary disease such as history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severely impaired lung function; (10) Severe infections that are active or poorly controlled clinically or severe infections within 4 weeks prior to enrollment. (11) Use of immunosuppressive drugs (excluding topical glucocorticoids or physiologic doses of systemic glucocorticoids, i.e., < 10 mg/day prednisone or equivalent doses of other glucocorticoids) within 4 weeks prior to enrollment. (12) Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Disease control rate;Time to progression; | — |
Countries
China
Contacts
Public ContactLiu Jingfeng
Fujian Cancer Hospital
Outcome results
None listed