hepatocarcinoma
Conditions
Interventions
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be enrolled, participants must meet all of the following inclusion criteria: 1) Age greater than 18 years old and less than 75 years old at the time of enrollment, both men and women. 2) Eastern Oncology Cooperative (ECOG) performance status score of 0 or 1. 3) The expected survival is greater than 3 months. 4) Histology or cytology confirmed hepatocellular carcinoma. 5) Surgery unresectable CNLC-stage I.A, I.B, II.A and Surgery-Resectable CNLC-II.b and III.a Liver Cancer, according to RECIST v l. l and mRECIST have at least one measurable lesion. 6) No previous systemic treatment or TACE treatment 7) The liver, kidney, bone marrow and coagulation function meet the following conditions: a) Neutrophil count (ANC=1.5×10^9/L, hemoglobin (Hb=90g/L), platelet count =75×10^9/L; b) Total bilirubin (TBIL) =1.5 times ULN, alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 5 times ULN, alkaline phosphatase (ALP) = 4 times ULN c) Creatinine = 1.5 times ULN, and creatinine clearance = 60mL/min; Serum albumin concentration = 30g/L d) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) = 1.5 times ULN 8) Female patients of childbearing age need to exclude pregnancy; 9) If other malignant tumors are combined, it is necessary to determine through multidisciplinary discussion that the history and treatment history of other tumors do not interfere with the efficacy and safety evaluation of this study protocol. 10. Ability to understand and sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1) previous HCC treatment history; 2) History of other complex surgery within 6 weeks; 3) history of previous organ transplantation; 4) are undergoing treatment from other clinical trials; 5) History of previous autoimmune diseases, inflammatory disorders (such as inflammatory bowel disease, etc.), diverticulitis, systemic lupus erythematosus, sarcoidosis syndrome, Wegener syndrome (granulomatous disease with multiple vasculitis, rheumatoid arthritis, etc.), except for the following conditions: vitiligo or alopecia areata, hypothyroidism that is stable after drug substitution therapy, chronic skin diseases that do not require systemic treatment, celiac diseases that can be controlled by diet alone; 6) Have primary immunodeficiency diseases; 7) Previous positive HIV test or acquired immunodeficiency syndrome; 8) Immunosuppressive drugs have been used within 14 days prior to treatment in this study. The following are exempt: a) Intranasal, inhaled, topical steroids or topical steroid injections b) Corticosteroid system application not exceeding physiologic doses (eg, 10 mg/day of prednisone or its equivalent). c) Use as a steroid for the treatment of anaphylaxis 9) Those who have received live attenuated vaccine within 30 days before the treatment of this study. Note: Live attenuated vaccines should also be avoided during the treatment period and for 30 days after the end of the treatment in this study; 10) Previous allergy to ipilimumab or durvalumab, or history of allergy to similar chemical molecules of the above drugs; 11) Uncontrollable intermittent recurrent disease, including but not limited to: persistent infection (including tuberculosis), hypertension (> 140/90 mmHg) that cannot be controlled by drugs, interstitial lung disease, severe chronic gastrointestinal disease with diarrhea, psychiatric illness or social impairment that cannot comply with the needs of clinical research, factors with high risk of side effects, inability to sign informed consent; 12) Have primary brain tumors (except meningiomas or other benign brain tumors), or any brain metastases, pia mater carcinoma, epilepsy that cannot be controlled by conventional drugs, and a history of new stroke in the past year; 13) History of previous serious systemic diseases, including: myocardial infarction or unstable angina, hypertensive crisis or hypertensive encephalopathy, NYHA grade 2 or above congestive heart failure, unstable symptomatic arrhythmias requiring pharmacological intervention, severe vascular disease or peripheral vascular disease with obvious symptoms within 12 months prior to the start of treatment of this study; 14) Coagulation, hemorrhagic or thrombotic disease within the 12 months prior to the start of treatment in this study; 15) Severe and irreparable trauma, ulceration or fracture; 16) pregnant or lactating women or subjects with family planning during the trial period; 17) Need for parenteral nutrition to maintain life; 18) According to the judgment of the investigator, there are other acute or chronic diseases, mental and psychological diseases, etc. that are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical resection rate;MPR;Duration of remission, DOR;Disease control rate, DCR;Progression free survival, PFS;Time to progression, TTP;Overall survival, OS;security; | — |
Countries
China
Contacts
Public ContactJun Xue,Tao Zhang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed