Hepatocellular Carcinoma
Conditions
Interventions
Case Series:IMRT+Sintilimab,and maintenance treatment with Sintilimab
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-75 year; 2) ECOG score 0-1; 3) Diagnosis of hepatocellular carcinoma: ?pathological diagnosis: histological and / or cytological examination diagnosed as HCC;?clinical diagnosis: evidence of cirrhosis and HBV and / or HCV infection, three-phase liver CT / MR scan showed that the intrahepatic mass was =1cm, the arterial phase was rapidly enhanced, and the venous phase were rapidly washed out; 4) Recurrence after surgery is not suitable for re-operation, relapsed and/or residual after RFA/TACE; 5) The expected survival period is = 3 months; 6) Liver function: Child-Pugh 5-7 points. ALT, AST < 2.5 ULN, ALP < 2.5ULN, total bilirubin <1.5 ULN, PT <1.5 ULN, INR <1.5. Marrow function: white blood cells = 3.0 x 109/L, granulocytes =1.5 x 109/L, PLT=75 x 109/L; HGB= 100g/l, renal function: BUN<40mg/dl, creatinine<2mg/ml; 7) Patients with hepatitis B virus infection should have effective antiviral therapy with HBV DNA <100 IU/ml; 8) Agree to join the group, be willing to cooperate with clinical research, and sign the informed consent form; 9) Female subjects of childbearing age or male subjects, effective contraceptive measures should be taken throughout the treatment period and 6 months after the treatment period.
Exclusion criteria
Exclusion criteria: 1) Hepatic function is poor, Child-Pugh>7 points or liver enzyme, coagulation, bilirubin bone marrow function does not meet the inclusion criteria; 2) History of esophageal varices bleeding, hepatic encephalopathy, massive ascites, and history of abdominal infection; 3) Lung, bone, mediastinal lymph nodes, multiple lower abdominal lymph nodes, pelvic lymph nodes and other distant metastases, can not be treated with local radiotherapy; 4) The tumor is close to the intestine and other organs at reisk(OARs), and it is difficult to tolerate the radiotherapy; the residual liver volume is <800ml, which is difficult to tolerate radiotherapy; 5) Those who are allergic to Sintilimab; 6) Patients have previously received immunotherapy, such as PD-1 antibody, PD-L1 antibody, CTLA4 antibody; 7) Use of immunosuppressive drugs for the past 4 weeks, excluding nasal glucocorticoids or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids (ie. no more than 10 mg/day of prednisone). Allows that the temporary use of glucocorticoids for dyspnea symptoms such as asthma, chronic obstructive pulmonary disease and the like.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all of AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;time to response;duration of response;progression free survival;overall survival; | — |
Countries
China
Contacts
Public ContactWang Weihu
Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute
Outcome results
None listed