Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Radiotherapy combined with sintilimab and bevacizumab analogues (IBI305)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Sign a written informed consent prior to the implementation of any test-related process; 2.Male or female >= 18 years; 3.The ECOG PS score is 0-1; 4.According to the diagnostic criteria of Chinese norms for diagnosis and treatment of primary liver cancer (2019 edition), HCC was diagnosed for the first time; 5.Unresectable locally advanced and advanced recurrent hepatocellular carcinoma (HCC); 6.At least first-line systemic antineoplastic therapy including PD-1 inhibitor monotherapy or combination regimen for hepatocellular carcinoma has been received in the past; 7.Patients can receive radiotherapy; 8.According to RECIST 1.1 criteria, there is at least one measurable lesion and at least one measurable focus without radiotherapy; 9.Child-Pugh score A; 10.Expected survival time > 3 months; 11.Thyroid function is normal, total triiodothyronine (T3) or free T3 and free thyroxine (T4) are in the normal range. It can be controlled by thyroid replacement therapy; 12.It has sufficient organ and bone marrow function, and the laboratory test value meets the following requirements within 7 days before entering the group, as follows: (1)Blood routine: absolute neutrophil count (absolute neutrophil count, ANC) >= 1.5 x 10^9 g/L; platelet count (platelet, PLT) >= 60 x 10^9 /L; hemoglobin content (hemoglobin, HGB) >= 90 g/L; (2)Liver function: serum total bilirubin (total bilirubin, TBIL) = 30 g/L; (3)Renal function: serum creatinine (Cr) = 50 mL/min (Cockcroft-Gault formula); urine routine results showed urinary protein = 2+ at baseline, 24-hour urine collection should be carried out and 24-hour urinary protein quantity < 1 g; (4)Coagulation function: international standardized ratio (international normalized ratio, INR) and activated partial thromboplastin time (activated partial thromboplastin time, APTT) <= 1.5 x ULN; 13.Male and premenopausal female patients: agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study treatment period. The female patients were not in lactation period and the blood or urine pregnancy test was negative within 7 days before entering the group.
Exclusion criteria
Exclusion criteria: 1.A history of hepatic encephalopathy or a history of liver transplantation; 2.History of autoimmune disease, history of autoimmune deficiency; 3.Pleural effusion, ascites and pericardial effusion that need to be drained with clinical symptoms; 4.In patients with acute or chronic active hepatitis B or C infection, hepatitis B virus (HBV) DNA > 2000 IU/mL or 10^4 copies/mL; hepatitis C virus (HCV) RNA > 10^3 copies/mL; hepatitis B surface antigen (HbsAg) and anti-HCV antibody were positive at the same time; 5.There is metastasis of the central nervous system; 6.The blood pressure was not well controlled. In the case of taking drugs, systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg; 7.Previous liver lesions have been treated with radiotherapy; 8.There have been esophageal or gastric varices bleeding caused by portal hypertension in the past 6 months; Severe (G3) varicose veins were known to be present in endoscopy within 3 months before the first administration. There is evidence of portal hypertension (including splenomegaly found by imaging examination) and the risk of bleeding is assessed by researchers; 9.Any life-threatening bleeding occurred in the past 3 months, including the need for blood transfusion, surgery or local treatment, and continuous drug treatment; 10.Arteriovenous thromboembolic events in the past 6 months, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep venous thrombosis or any other serious thromboembolism. Implantable intravenous infusion port or catheter-derived thrombosis, or superficial venous thrombosis, except for thrombus stability after routine anticoagulant therapy. Prophylactic use of small doses of low molecular weight heparin (such as enoxaparin 40 mg/day) is allowed; 11.Severe bleeding tendency or coagulation dysfunction, or undergoing thrombolytic therapy; 12.There are previous and present pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function and so on; 13.Active pulmonary tuberculosis (TB) is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before the first administration; 14.People infected with human immunodeficiency virus (HIV) (positive for HIV-1 and HIV-2 antibodies) are known to be infected with syphilis; 15.Severe infection that is active or poorly controlled clinically. Severe infection within 4 weeks before the first administration, including, but not limited to, hospitalization for complications of infection, bacteremia or severe pneumonia; 16.Immunosuppressive drugs were used within 4 weeks before the first administration, excluding nasal, inhaled or other topical glucocorticoids or physiological doses of systemic glucocorticoids (that is, no more than 10 mg/day prednisone or equivalent doses of other glucocorticoids), temporary use of glucocorticoids due to the treatment of dyspnea in asthma, chronic obstructive pulmonary disease and other diseases; 17.Within 2 weeks before the first administration, he has received traditional Chinese medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use of pleural effusion or ascites); 18.Other malignant tumors were diagnosed within 5 years before the first administration, excluding radical skin basal cell carcinom
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate of lesions without radiotherapy;Disease control rate;Progression-free survival (PFS);Overall survival (OS);Security; | — |
Countries
China
Contacts
Public ContactXue Jun
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed