Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborator: 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.