Primary liver cancer with malignant peritoneal effusion
Conditions
Interventions
experiment group:Intraperitoneal Injection of Sintilimab Combined with Best Supportive Care
Sponsors
Jinling Hospital, Medical School of Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years. 2. Clinically diagnosed or histologically/cytologically confirmed primary liver cancer, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma, and gallbladder cancer. 3. Hemorrhagic ascites with pathological or cytological confirmation of malignancy, or tumor-related ascites, with a volume of moderate or higher ascites (>=4 cm) requiring clinical intervention as determined by the treating physician. 4. At least one measurable lesion as per the RECIST 1.1 criteria. 5. ECOG performance status: 2-3. 6. Expected survival >= 2 months. 7. Normal major organ functions, meeting the following criteria: • Hematology (no blood transfusion or blood products in the past 14 days, no use of G-CSF or other hematopoietic growth factors): a. Hemoglobin (HB) >= 80 g/L. b. Absolute neutrophil count (ANC) >= 1.0 × 10^9/L. c. Platelet count (PLT) >= 60 × 10^9/L. • Biochemistry: a. Total bilirubin (TBIL) 45 mL/min (Cockcroft-Gault formula). 8. Chronic HBV infection: Subjects with detectable HBV infection must receive antiviral therapy, and HBV DNA must be < 10,000 IU/mL. 9. Women of childbearing potential must have implemented reliable contraception methods or have undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and agree to use appropriate contraception methods during the study and for 8 weeks after the last dose of the investigational drug. Male subjects must agree to use appropriate contraception methods or have undergone surgical sterilization during the study and for 8 weeks after the last dose of the investigational drug. 10. The subject must voluntarily participate in the study, sign an informed consent form, exhibit good compliance, and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Asymptomatic ascites that does not require clinical intervention. 2. Contraindications for puncture treatment. 3. Contraindications for immunotherapy (including long-term use of steroids, history of radiation-induced pneumonia, radiation-induced hepatitis, radiation-induced enteritis, etc.). 4. Active autoimmune diseases (e.g., vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.). 5. Co-infection with hepatitis B and C, active hepatitis C, HIV, syphilis, active tuberculosis, etc. 6. Severe infections in the active phase or with poor clinical control. Severe infections within 4 weeks prior to the first dose, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications. 7. Known history of organ transplantation (allogeneic) or autologous hematopoietic stem cell transplantation. 8. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severely impaired lung function. 9. History of substance abuse that cannot be controlled, or individuals with mental disorders. 10. Participation in other clinical trials of anticancer drugs within the last 4 weeks. 11. Previous use of PD-1/PD-L1 monoclonal antibodies or other immunotherapy drugs via intraperitoneal administration. 12. History or current diagnosis of other untreated malignancies, except for cured skin basal cell carcinoma, cervical carcinoma in situ, or superficial bladder cancer. 13. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to take effective contraceptive measures. 14. Any other condition judged by the investigator to potentially affect the conduct of the clinical study or the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;progression-free survival;disease control rate;puncture free survival;Malignant ascites control rate; | — |
Countries
China
Contacts
Public ContactChao Chen
Jinling Hospital, Medical School of Nanjing University
Outcome results
None listed