Hepatocellular carcinoma
Conditions
Interventions
First-line treatment cohort:Donafenib tablet, 200 mg BID Po
Camrelizumab, 200 mg Q3W IV
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Voluntary enrollment and signed ICF; 2) Age 18-75 (including 75), male or female; 3) Patients with hepatocellular carcinoma clinically diagnosed or confirmed by pathological tissue/cytology according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2019 edition); 4) Patients with Unresectable or metastatic hepatocellular carcinoma; 5) A) first-line treatment cohort: patients who have not received systematic treatment; B) Second-line treatment cohort: patients who progressed or were intolerant after first-line system therapy; (6) Patients who had received adjuvant chemotherapy after local treatment, and the end of chemotherapy was more than 12 months, and patients with disease progression or metastasis were also included;Surgical treatment >3 months, and the end time of the last intervention, radiotherapy, ablation and systemic drug therapy >4 weeks; 7) Have at least one measurable lesion; v measurable lesions were defined as the longest single diameter =10 mm non-lymphoid lesions, or the shortest diameter =15 mm lymph node lesions. v a lesion that has progressed according to RECIST1.1 criteria and has a maximum diameter =10 mm after previous intervention, radiotherapy or ablation may also be a measurable target. 8) Expected survival time =3 months; 9) ECOG PS score was 0~1; 10) Child-pugh grade A; 11) Can cooperate to observe adverse events and efficacy; 12) The function of major organs is normal, that is, the following criteria are met: Routine blood tests (no blood transfusion or G-CSF use within 14 days prior to screening) : A) Hemoglobin =90 g/L; B) Absolute neutrophil count (ANC) =1.5×109/L; C) Platelet count =75×109/L; Blood biochemical tests (no albumin use within 14 days prior to screening) : D) Albumin =28 g/L; E) Total bilirubin =2× upper limit of normal (ULN); F) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =5×ULN; G) Alkaline phosphatase (ALP) =5×ULN; H) Creatinine =1.5×ULN; Blood coagulation function: I) International normalized ratio (INR) or prothrombin time (PT) =1.5×ULN; J) Activated partial thrombin time (APTT) =1.5×ULN.
Exclusion criteria
Exclusion criteria: Previous or co-existing diseases: 1)Fibrolaminar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components previously diagnosed by histology/cytology; 2) A history of malignant tumors other than hepatocellular carcinoma, unless the following criteria are met: A) The patient has received potentially curative treatment and there is no evidence of the disease for 5 years; B) Successfully received excised basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ and other carcinoma in situ; 3) diffuse tumor lesions; 4) The tumor thrombus invaded the main portal vein; 5) A history of hepatic encephalopathy, hepatorenal syndrome, or a history of liver transplantation; 6) Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage; 7) Central system metastasis; 8) Previous history of severe mental illness; 9) Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the drug under study (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); Previous or combined medication/treatment: 10) Previous allogeneic stem cell or solid organ transplantation; 11) Concomitant administration of drugs that may prolong QTc and/or induce tortuous apex ventricular tachycarta (Tdp) or affect drug metabolism; 12) Active or previously documented autoimmune or inflammatory diseases (including but not limited to:Autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, the pituitary gland inflammation, thyroid function hyperfunction or decline, which is to be bronchodilator treatment of asthma, etc.), patients with vitiligo or fully relieve asthma in childhood, adult without any intervention can be incorporated into; 13) Previous allogeneic stem cell or solid organ transplantation; 14) Previous treatment with excessive narfinil; 15) Had been treated with systemic immunosuppressive drugs within 2 weeks prior to enrollment, or was expected to require systemic immunosuppressive drugs during the study, except for: A) intranasal, inhaled, topical or local injection (e.g., intraarticular injection) of corticosteroids; B) systemic corticosteroids not exceeding 10 mg/ day of prednisone or other equivalent effects; C) prophylactic use of corticosteroids for hypersensitivity reactions; Security: 16) The patient has a known or suspected history of allergy to donafenil or similar drugs, or a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is allergic to excipients of study drugs; 17) Have active bleeding or abnormal coagulation function, have bleeding tendency or are receiving thrombolysis, anticoagulation or antiplatelet therapy; 18) Thrombosis or thromboembolic events, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc. in the past 6 months; 19) Bleeding events from esophageal or fundus varices due to portal hypertension within the previous 6 months, or any life threatening bleeding events within 3 months; 20) Cardiovascular disease with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina or coronary artery bypass grafting within the previous 6 months, congestive heart failure (NYHA grade >2), poorly controlled or pacemaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;ORR;DOR;Survival rates at 6, 9, 12, and 18 months;ECOG;AFP;AE;SAE; | — |
Countries
China
Contacts
Public ContactHaitao Zhao
Peking Union Medical College Hospital
Outcome results
None listed