HCC
Conditions
Interventions
The experimental group:Sintilimab
Sponsors
Department of Medical Oncology of PLA Cancer Center, Jinling Hospital, Nanjing
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 75 years;. 2. HCC confirmed by clinical diagnosis or histological/cytological diagnosis, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma; 3. For hemorrhagic peritoneal effusion, or the peritoneal effusion is pathologically or cytologically confirmed to be malignant, and the peritoneal effusion is medium or above (>= 4cm), the clinician determines that intervention is necessary. 4. At least 1 measurable lesion according to RECIST1.1 5. ECOG score: 0-3; 6. Expected survival >= 3 months; 7. The major organs are functioning normally, that is, they meet the following criteria: (1) Routine blood examination standards should be met (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors have been used to correct) : a.HB >= 80 g/L b.ANC >= 1.0 x 10^9/L c.PLT >= 60 x 10^9/L (2) Biochemical examination shall meet the following standards: A.TBIL 45 ml/min (Cockcroft-Gault formula); 8. Chronic HBV infection. Subjects with detectable HBV infection must receive antiviral therapy and HBV DNA < 10000IU/mL; 9. Women of child-bearing age must have used reliable contraceptives or had a pregnancy test (serum or urine) within 7 days prior to enrolment, be negative, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug.For men, consent must be given to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the experimental drug; 10. Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Asymptomatic abdominal effusion and no need for clinical intervention; 2. There are contraindications for puncture treatment; 3. Immunotherapy contraindications (including long-term use of hormones, radiation pneumonia, radiation hepatitis, radiation enteritis, etc.); 4. Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.); 5. Patients with HBV complicated with HCV, active HCV, HIV, syphilis infection, active tuberculosis, etc.; 6. Severe infections that are active or poorly controlled clinically.Severe infection, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia, occurred 4 weeks prior to initial administration; 7. Known history of allogeneic organ transplantation and autologous hematopoietic stem cell transplantation; 8. Previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe pulmonary function impairment and other pulmonary diseases; 9. People who have a history of abuse of psychotropic substances and are unable to get rid of them or have mental disorders; 10. Participated in clinical trials of other anti-tumor drugs within the first 4 weeks; 11. Intraperitoneal use of PD-1/PD-L1 monoclonal antibody and other ICIs; 12. Previous or coexisting uncured malignancies, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer; 13. Pregnant or lactating women;Patients unwilling or unable to take effective contraceptive measures; 14. The investigator judges other circumstances that may affect the conduct of the clinical study and the judgment of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safty;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Puncture free survival;progression-free survival;Malignant ascites control rate;objective response rate;ECOG score improved; | — |
Countries
China
Contacts
Public ContactXiufeng Liu
Department of Medical Oncology of PLA Cancer Center, Jinling Hospital, Nanjing, China
Outcome results
None listed