Hepatocellular carcinoma
Conditions
Interventions
Experimental group:TACE was treated 2-3 times for 8-12 weeks
Toripalimab combined with radiotherapy for 6 weeks
Toripalimab was repeated every 3 weeks until the end of cycle 9 or PD or other early termination occurred. The dosage of targeted drugs is selected by researchers according to the patient's situation.
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subject aged 18 to 75 years, male or female; 2.Primary hepatocellular carcinoma confirmed by histology, advanced hepatocellular carcinoma confirmed by Pathology and clinical, stage: B-C, Barcelona clinical stage; 3.The pre-treatment evaluation suggested that surgical treatment could not be performed or surgical treatment was refused. 4.At least one measurable lesion (according to RECIST v1.1); 5.ECOG score of 0 -1; 6.Life expectancy >= 12 weeks; 7.Vital organ function meets the following requirements (excluding any blood components and cell growth factors within 14 days): (1)Normal bone marrow reserve function, neutrophils >=1,500/mm^3, platelet count >=100,000/mm^3, hemoglobin >=5.6 mmol/L (9g/dL); (2)Normal renal function or serum creatinine =60 mL /min; (3)Normal liver function or bilirubin <=1.5 times ULN, ASAT & ALST<=1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1.Patients who have previously radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy; 2.Patients with distant metastasis confirmed by imaging; 3.Subjects with previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 4.Previous tripalimab or other PD-1/PD-L1 treatment could not be included in the group; Patients with known prior allergy to large molecule protein preparations, or known allergy to any tripalimab component; 5.Patients with any active autoimmune disease or a history of autoimmune disease; 6.Patients who are receiving immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ day of prednisone or other efficacy hormone) and who continued to receive such therapy within 2 weeks prior to enrolment; 7.Patients with clinical symptoms of ascites or pleural effusion that require therapeutic puncture or drainage; 8.Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1)NYHA grade 2 or higher heart failure; (2)Unstable angina pectoris; (3)Myocardial infarction within 1 year; (4)Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 9.Patients with abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg> 2g /L), with bleeding tendency or receiving thrombolysis or anticoagulation therapy; 10.Patients with current (within 3 months) gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator; 11.Patients with previous or current severe bleeding (bleeding >30 ml within 3 months), hemoptysis (fresh blood >5 ml within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 12.Subjects with active infection or fever of unknown cause >38.5 ? during screening or before first administration (fever caused by tumor can be included according to the investigator's judgment); 13.To study patients with abdominal fistula, gastrointestinal perforation or abdominal abscess less than 4 weeks before medication; 14.Patients with past and present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function; 15.Subjects with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA>=10^4 / ml; HCV reference: HCV RNA>=103/ml); Chronic hepatitis B virus carriers, HBV DNA < 2000 IU/ml (<104 copies /ml), must receive antiviral therapy during the trial to be enrolled; 16.Participating in another clinical study or less than 1 month from the end of the previous clinical study; Subjects who may receive other systemic antitumor therapy during the study; 17.The number of patients who received live vaccine less than 4 weeks before the study administration or who may receive it during the study period; 18.Patients with a known history of psychotropic substance abuse, alcohol abuse or drug abuse; 19.Patients who are unable or do not agree to bear the costs of examinations and treatment at their own expense; 20.The investigato
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Vital signs;Laboratory index;Adverse event;Serious adverse event;Completion rate of radiotherapy treatment;Median number of completed cycles of chemotherapy;Life quality score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;1 - and 3-year progression-free survival;1 - and 3-year overall survival rates; | — |
Countries
China
Contacts
Public ContactYue Jinbo, Zhu Kunli
Shandong Cancer Hospital
Outcome results
None listed