hepatocellular carcinoma with extrahepatic metastasis
Conditions
Interventions
experiment group:regorafenib and toripalimab
Sponsors
Beijing Youan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old (inclusive) male and female; 2. HCC was diagnosed by histopathological examination or with reference to the guidelines of diagnosis and treatment for Primary liver Cancer (2019 Edition); 3. Barcelona clinical liver cancer staging (BCLC staging) stage C; 4. In the past, sorafenib, lenvatinib, apatinib and other TKI targeted drug resistance, and did not receive the following systematic treatment (mainly including systemic chemotherapy and immunotherapy containing CTLA-4, PD-1/PD-L1 monoclonal antibody); 5. According to the RECIST v1.1, more than one measurable active focus. Requirements: the selected target lesions had not received local treatment, or the target lesions were located in the previous local treatment area, but were later identified as PD by imaging examination; 6. The Child-Pugh grade A or B, and no history of hepatic encephalopathy; 7. The physical strength score (PS) of ECOG (Eastern American Cancer Cooperation) 0-2. 8. The expected survival time was = 3 months. 9. The function of major organs meets the following requirements: no blood transfusion, no use of hematopoietic stimulating factors (including G-CSF, GM-CSF, EPO and TPO, etc) and infusion of human albumin preparation within 14 days before screening. Absolute neutrophil count = 1.5 × 109/L. Platelet count = 50 × 109/L. Hemoglobin = 80g/L. Serum albumin = 29g/L. Serum total bilirubin = 2.0 × normal range upper limit (ULN). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 5 × ULN. Serum creatinine (Cr) = 1.5 × ULN or Cr clearance = 40mL/min (calculated by Cockcroft-Gault formula). The international standardized ratio (INR) = 2 or the prothrombin time (PT) exceeds the upper limit of the normal range = 6 seconds. Urinary protein < 2+ [if urinary protein = 2g, 24-hour (h) urinary protein should be quantified, and those with 24-hour urinary protein < 1.0g can be included in the group). 10. If HBsAg (+) and / or HBcAb (+), HBV DNA must be at least < 500IU/mL and continue to receive effective anti-HBV treatment during the study period, or start using entecavir or tenofovir throughout the study. Simultaneous infection of HBV and HCV was excluded. Patients with a history of HCV infection but negative PCR results of HCVRNA can be considered not infected with HCV. 11. Fertile female subjects must undergo a urine or serum pregnancy test within 7 days before enrollment. The results are negative and the female subjects are willing to take effective contraceptive measures during the study period and within at least 6 months after the last administration; male subjects whose partners are women of childbearing age must agree to take effective contraceptive measures during the study period and at least 6 months after the last administration.
Exclusion criteria
Exclusion criteria: 1. Cholangiocarcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and liver fibrolamellar carcinoma; 2. Suffered from malignant tumors other than HCC within 5 years; except for the cured localized tumors, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ; 3. Treated with experimental drugs within 4 weeks before enrollment; palliative radiotherapy was given to the metastatic lesions of bone within 2 weeks before enrollment. The toxic reaction (except alopecia) caused by previous treatment did not recover to 10mg or equivalent dose) or other immunosuppressive drugs within 14 days prior to the administration of the study drug. Inhaled or topical steroids and adrenal replacement steroids with equivalent daily doses of prednisone > 10mg in the absence of active autoimmune disease; 12. Previous organ transplants, human immunodeficiency virus (HIV) positive, or acquired immunodeficiency syndrome (AIDS); 13. Received live/attenuated vaccine within 30 days after the first treatment; 14. Patients with any severe and/or uncontrolled other diseases, including, but not limited to, active or uncontrolled severe infections, renal failure requiring hemodialysis or peritoneal dialysis, major mental illness, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction, arrhythmia, severe atrioventricular block, cardiac insufficiency, severe valvular
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;DOR; | — |
Countries
China
Contacts
Public ContactChunwang Yuan
Beijing Youan Hospital Capital Medical University
Outcome results
None listed