Liver Cancer
Conditions
Interventions
Case series:Targeted immunity combined with radiotherapy
Sponsors
Cancer Hospital Shenzhen Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Unresectable primary hepatocellular carcinoma confirmed by histological and clinical diagnosis; 2. Normal liver volume (whole liver minus primary and intrahepatic metastatic ) >=700cc; 3. No previous or only first-line sorafenib / lovaratinib treatment; 4. Male or female aged 18 to 75 years, and sign the informed consent; 5. With an ECOG score of 0 or 1, expect to survive for more than 3 months; 6. Agree to provide previously stored tumor tissue samples or to collect tumor lesion tissue for biomarker analysis. 7. According to RECIST 1.1, there is at least one measurable lesion 8. Good organ function: hematology: WBC >=4x10^9/L, neutrophils >=2x10^9/L, hemoglobin >=9 g/dL, platelets >=100x10^9/L. Liver function: bilirubin =3g/dL; Child-pugh grade A; International standardized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) =60 mL/min according to Cockcroft-Gault formula.
Exclusion criteria
Exclusion criteria: 1. Active or untreated CNS metastases (e.g. cerebral or peliuminal metastases) determined by CT or magnetic resonance imaging (MRI) during screening and prior imaging assessments.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more); 2. Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L calcium or calcium > 12 mg/dL or corrected serum calcium > ULN);Patients who received Dinoselmer before randomization must agree to discontinue Dinoselmer therapy and switch to bisphosphate alternative therapy after entering the study; 3. Hepatitis B virus infection, HBV-DNA > 2000IU/ml; 4. Have history of malignant tumor except liver cancer in the last 5 years, Except for those whose risk of metastasis or death is negligible [such as expected total 5 years survival rate > 90%) and who are expected to be cured after treatment, such as has the appropriate treatment of cervical carcinoma in situ, basal or squamous cell cancer, radical surgery treatment of localized prostate cancer, as well as the radical surgical treatment of breast ductal carcinoma in situ; 5. A history of autoimmune diseases or other diseases requiring immunosuppressive therapy; 6. Patients who had received hormone therapy in the previous 4 weeks; 7. Patients treated with antibiotics 2 weeks prior to enrollment; 8. Patients treated with other immunocheckpoint inhibitors; 9. Women who are pregnant, breastfeeding or planning to become pregnant during the study period; 10. Known allergy or hypersensitivity to any component of a biological drug or sindilizumab preparation produced from Chinese hamster ovary cells; 11. Patients who received other experimental drug therapy or participated in clinical studies for other therapeutic purposes within 28 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactHua Ren
Department of Radiotherapy, Cancer Hospital Shenzhen Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed