Status:
UNKNOWN
Tislelizumab Combined With IMRT Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Due to the biological characteristics and liver anatomical characteristics of liver cancer, liver cancer cells easily invade the vascular system, especially the portal venous system, forming portal ve...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed hepatocellular carcinoma
- Patients with at least one measurable lesion
- Resectable primary lesion, PVTTⅡ-Ⅲtype
- No previous treatment for hepatocellular carcinoma
- Eastern Cooperative Oncology Group(ECOG): Performance Status(PS)score 0-1
- Child-Pugh score A
- Expected survival ≥ 3 months
- Baseline blood routine and blood biochemical indicators should meet the following criteria:
- hemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1.5 × 10 \^/L, platelet count ≥ 75 × 10 \^/L aspartate or alanine aminotransferase 5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the ULN, serum albumin ≥ 30 g/L; serum creatinine 1.5 times the ULN; international normalized ratio (INR)) ≤ 2 or prothrombin time (PT) more than the upper limit of normal range ≤ 6 seconds
- Appropriate to participate in this trial as assessed by the investigator before entering the study
- Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study
- Signed informed consent.
Exclusion
- Imaging showed distant metastasis
- Previous treatment with other effective regimens (including surgery, radiotherapy, systemic therapy, etc.)
- Previous allergic reactions to the same kind of drugs
- Pregnant or lactating patients
- Active hepatitis B or C (hepatitis B: HBsAg positive and Hepatitis B (HBV )DNA ≥ 1\*10\^4 IU/ml; hepatitis C: hepatitis C virus (HCV) antibody and HCV RNA positive, requiring simultaneous antiviral therapy)
- Pericardial effusion, uncontrolled pleural effusion or clinically severe ascites at screening
- History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease
- Suffering from severe cardiovascular disease within 12 months before screening, such as symptomatic coronary heart disease,≥II congestive heart failure, uncontrolled arrhythmia, infarction, etc
- Any active immunodeficiency or autoimmune disease at screening and/or any history of immunodeficiency or autoimmune disease that may recur (such as hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc.)
- Use of steroids or other systemic immunosuppressive therapy 14 days before enrollment; use of steroids or other systemic immunosuppressive therapy
- Patients with other previous malignancies that are not cured; Patients with other previous malignancies that are not cured
- Immunocompromised patients, such as immunocompromised patients, such as human immunodeficiency virus (HIV) positive; positive
- With uncontrollable psychosis; With uncontrollable psychosis
- Other factors make the investigators think it is inappropriate to participate in this trial.
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04850157
Start Date
April 20 2021
End Date
December 20 2023
Last Update
April 20 2021
Active Locations (1)
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1
Zhongshan hospital, Fudan University
Shanghai, China