Overview
Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.
Status:
Recruiting
Recruiting
Trial end date:
2022-09-30
2022-09-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shanghai Zhongshan HospitalCollaborator:
Innovent Biologics (Suzhou) Co. Ltd.Treatments:
Chlorotrianisene
Criteria
Inclusion Criteria:1. Age: 18 - 80 years old and life expectancy of at least 12 weeks.;
2. Clinically or histologically diagnosed as HCC and the diameter of target tumor lesion
≥ 5 cm;
3. Child-pugh classification A or B (score < 7);
4. BCLC Staging as B or C;
5. ECOG 0-1;
6. Patients voluntarily entered the study and signed informed consent form (ICF).
Exclusion Criteria:
1. History of treatment with any local treatment (exception of liver transplantation),
systemic .anti-cancer therapy, or immunotherapy;
2. The surgeon assessed that the tumor lesion was not unsuitable for microwave ablation;
3. Any contraindications for hepatic embolization procedures:
1. Known hepatofugal blood flow;
2. Total thrombosis of main portal vein.
4. The tumor thrombus of main portal vein, IVC or right atrium;
5. Tumor burden ≥ 70% of liver volume; and no measurable site of disease as defined by
modified RECIST (mRECIST) criteria with spiral CT scan or MRI;
6. Subjects with chronic HBV infection have HBV DNA viral load > 100 IU/mL at screening,
and have not received antiviral therapy prior to initiation of study therapy; In
addition, coinfection of HBV and HCV;
7. The alcoholic or pregnant women;
8. Patients with second primary cancer or history of other cancer within 3 years;
9. Diagnosis of active autoimmune disease, immunodeficiency, or patient is receiving
chronic systemic steroid therapy or any other form of immunosuppressive therapy within
7 days prior to the first dose of Sintilimab-monotherapy treatment;
10. Blood count, liver function: Haemoglobin < 9.0 g/dL, white cell count < 1.0 x10^9/L;
Total bilirubin > 3 mg/dL; Aspartate Aminotransferase (SGOT) or Alanine
aminotransferase (SGPT) > 5 x upper normal limit (ULN), Albumin < 2.8g/dL;
International normalized ratio (INR) >2.3;
11. Renal function dysfunction: Serum Creatinine >2 mg/dL or creatinine clearance (CrCl) <
30 mL/min (if using the Cockcroft-Gault formula ); and severe heart, lung, brain or
other organ disease;
12. Non-compliance with TACE or ablation procedure.