Hepatocellular carcinoma
Conditions
Interventions
Intermediat liver cancer:TACE combined with PD-1 inhibitor
advanced liver cancer:TACE combined with PD-1 inhibitor
Sponsors
Xijing Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects who voluntarily participated and signed the informed consent in writing; 2. Subjects aged from 18 to 75, regardless of gender; 3. Patients diagnosed with primary hepatocellular carcinoma (HCC); According to mrecist, there was at least one measurable lesion; 4. Patients with an estimated survival time of more than 6 months; 5. Cohort 1: intermediate stage liver cancer, BCLC stage B; Cohort 2: advanced liver cancer, BCLC stage C, ECoG score 1, and / or lymph node metastasis, portal branch tumor thrombus (Cheng's classification was type I and type II) 6. Patients with liver function child Pugh score = 1000 / mm3 (1.0 x 10^9/L) (2) Platelet count (PLT) >= 40000 / mm3 (40 x 10^9/L) (3) Hemoglobin (HB) >= 9 g / dl (90 g / L); (4) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level = 50 ml / min; (6) Left ventricular ejection fraction (LVEF) >= 50%; QTc was less than 450 ms in male and less than 470 MS in female. 9. Patients with hepatitis B must meet the requirement of HBV-DNA < 500 IU / ml and receive antiviral treatment according to the treatment guidelines; In the case of hepatitis C patients, HCV-RNA positive patients must receive antiviral treatment according to the guidelines; 10. Female subjects of childbearing age must carry out the pregnancy test within one week before the start of the study, and the result is negative, and they are willing to use a highly effective contraceptive method (such as intrauterine device, contraceptive or condom) approved by medicine during the study period and within three months after the last Administration of the study drug; For male subjects whose partners are women of childbearing age, surgical sterilization should be adopted, or they agree to use effective contraceptive methods during the study period and within 3 months after the last study; 11. Patients with good compliance are expected to cooperate with the study according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients not suitable for TACE treatment, such as severe arteriovenous leakage; 2. Patients who had gastrointestinal bleeding within 1 month before enrollment, and did not receive targeted treatment, still had high risk of bleeding; 3. Patients with refractory ascites; 4. Patients with other active malignancies within 2 years before entering the study. Except for skin basal cell carcinoma or squamous cell carcinoma, superficial bladder carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ and papillary thyroid carcinoma which can be treated locally and have been cured; 5. Patients who are known to be allergic to the study drug or any of its excipients; Or severe allergic reaction to other monoclonal antibodies; 6. Patients who have received immunotherapy for PD-1 and PD-L1 in the past; 7. Patients who received the following treatments or drugs before or at present in the first study: (1) Immunosuppressive drugs were used within 7 days before or at present, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e. no more than 10 mg / D prednisone or other corticosteroids of the same pharmacophysiological dose); (2) They have received immunomodulatory drugs (such as thymosin, interferon and interleukin) within 3 weeks before the first medication or at present; (3) Live attenuated vaccine was inoculated within 28 days before the first study drug treatment or within 60 days after the end of the study drug treatment; 8. Patients who are currently participating in other research and treatment; Or participated in any other drug clinical study within 4 weeks before the first administration, or no more than 5.5 months after the last administration The first phase of the project; 9. Patients with autoimmune diseases need systemic treatment in the past two years; Or with a history of autoimmune disease and expected recurrence; 10. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. Patients infected with human immunodeficiency virus (HIV) or with immunodeficiency; 12. Patients with major organ failure, such as compensatory heart, lung, liver and kidney failure; Severe liver and kidney dysfunction, affecting the normal drug metabolism; 13. Within 6 months before entering the study, patients with myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; Hypertension with poor drug control (continuous increase of systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); 14. Patients who had been using antibiotics for more than 7 days within 4 weeks before the first administration, or had fever > 38.5 degrees C of unknown origin during the screening period / before the first administration (according to the judgment of the researcher, fever caused by tumor can be included in the group); 15. Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures; 16. Patients with a clear history of neurological or mental disorders, including epilepsy and dementia; Known history of psychotropic drug abuse or drug abuse; 17. Patients considered unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, Objective Response Rate;ORR, Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, Overall Survival;PFS, Progression-Free Survival;DCR, Disease Control Rate;DOR, Duration Of Response;TTP, Time To Progresson; | — |
Countries
China
Contacts
Public ContactTie Jun
Xijing Hospital of Air Force Medical University
Outcome results
None listed