HCC
Conditions
Interventions
Modified HAIC combined with sindilizumab and bevacizumab analogue therapy:Modified HAIC combined with sindilizumab and bevacizumab analogue therapy
Sponsors
Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Men or infertile women between the ages of 18 and 75; 2) Signed informed consent; 3) Patients who, in the opinion of the investigator, are capable of complying with the study protocol; 4) a histological or cytological or clinical diagnosis of hepatocellular carcinoma (HCC); 5) Not suitable for radical surgical treatment; 6) no previous systemic antitumour therapy 7) at least 1 measurable (according to RECIST 1.1) untreated lesion; 8) pre-treatment tumour tissue sample (if available). If tumour tissue is available, submit 1 formalin-fixed, paraffin-embedded (FFPE) tumour sample in a paraffin block (preferred) or approximately 10-15 slides containing unstained, freshly cut, serial sections, together with a copy of the relevant pathology report within 4 weeks of enrolment. If the FFPE sample described above is not available, any type of sample (including fine-needle aspiration biopsy samples, cell mass samples [e.g., samples originating from pleural effusions], and lavage samples) may also be accepted. A copy of the relevant pathology report should be provided with this sample. If tumour tissue is unavailable (e.g., exhausted because of previous diagnostic testing), the patient remains eligible to participate in the study; 9) ECOG physical status score of 0 or 1 within 14 days prior to enrolment; 10) Child-Pugh grade A or =7 of B within 14 days prior to enrolment; 11) Adequate haematological and organ function, based on the following laboratory results obtained within 14 days prior to enrolment (unless otherwise stated): absolute neutrophil count (ANC) = 1.5 x 109/L (1500/µL) without granulocyte colony-stimulating factor support; lymphocyte count = 0.5 x 109/L (500/µL); platelet count = 70 x 109/L (50,000/µL); and platelet count = 1.5 x 109/L (1,000/µL). L (50, 000/µL); haemoglobin = 85 g/L (8.5 g/dL), for which transfusion to the patient may be permitted to meet this criterion; AST, ALT and alkaline phosphatase (ALP) = 5 times the upper limit of normal (ULN); serum bilirubin = 2 times the upper limit of normal (ULN); and serum creatinine = 1.5 times the upper limit of normal (ULN) or calculated creatinine clearance =50 mL/min (calculated using the Cockcroft-Gault formula); serum albumin =28 g/L (2.8 g/dL); in patients not receiving anticoagulation: INR or APTT =2 times the upper limit of normal (ULN) or prolongation of the prothrombin time by no more than 3 seconds. Urine fibre paper test result for proteinuria <2+ (performed within 14 days prior to initiation of study treatment); patients with a baseline fibre paper urine test result of =2+ proteinuria should have a 24-hour urine collection, which must then be confirmed to have a urine protein level of <1g over a 24-hour period. 12) Any acute, clinically significant treatment-related toxicity (from prior therapy) must have resolved to = Grade 1 prior to study entry, with the exception of alopecia; 13) Negative HIV antibody test result at screening; 14) Patients with active hepatitis B virus (HBV) infection: HBVDNA <2000 IU/mL obtained within 28 days prior to initiation of study treatment and who have received at least 7 days of anti-HBV therapy (based on local standard of care, e.g., entecavir) prior to enrolment and are willing to continue treatment for the duration of the study; patients with active hepatitis C virus (HCV) infection. HCVRNA <2000 IU/mL obtained within 28 days prior to initiation of study treatment and who have received at least 7 days of anti-HCV treatment prior to
Exclusion criteria
Exclusion criteria: 1) History of molluscum contagiosum; 2) Current or previous autoimmune disease or immunodeficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, desiccation syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: patients with history of autoimmune-associated hypothyroidism and receiving thyroid hormone Patients with autoimmune-associated hypothyroidism on thyroid hormone replacement therapy are eligible; patients with controlled type 1 diabetes mellitus on insulin therapy are eligible; patients with eczema, psoriasis, chronic lichen simplex, or vitiligo (e.g., excluding patients with psoriatic arthritis) with dermatological manifestations only are eligible provided that all of the following conditions are met: 1. the area of the skin lesion must be less than 10 percent of the body surface area 2. the disease is well controlled at baseline and only needs to be treated by a physician. Disease is well controlled at baseline and requires only low potency topical glucocorticoid therapy 3) No acute exacerbation of a pre-existing condition within the last 12 months requiring treatment with psoralen plus A-band ultraviolet radiation, methotrexate, vitamin A acids, biologics, oral calmodulin nephosphatase inhibitors, or high potency or oral glucocorticoid therapy; 3) Idiopathic pulmonary fibrosis, organic pneumonia (e.g., occlusive bronchiectasis), drug-induced or idiopathic pneumonia, or evidence of active pneumonia visible on screening chest computed tomography (CT) maps. Allow for radiation areas (fibrosis) with previous radiation pneumonitis; 4) Known active tuberculosis; 5) significant cardiovascular disease (e.g., New York Heart Association Class II or worse heart disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment), unstable arrhythmia, or unstable angina pectoris within 3 months prior to initiation of study treatment; 6) history of congenital long QT syndrome or corrected QT interval >500ms at screening (calculated using the Fridericia method); 7) History of uncorrectable electrolyte disturbances such as serum potassium, calcium or magnesium; 8) Major surgical treatment (other than diagnostic) within 4 weeks prior to initiation of study treatment or anticipated need for major surgical treatment during the study period; 9) Previous malignancy other than HCC within 5 years prior to screening, except for malignancies with negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated in situ cervical cancer, non-melanoma skin cancer, limited prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 10) Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalisation for complications of infection, bacteraemia or severe pneumonia; 11) Therapeutic antibiotics given orally or intravenously within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent urinary tract infections or exacerbations of COPD) are eligible for study participation; 12) Prior allogeneic stem cell or solid organ transplantation; 13) Received a live attenuated vaccine within 4 weeks prior to initiation of study treatment or are expected to require such a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE;Overall survival, OS;DCR;Progression free survival, PFS;Time to progression , TTP;Duration of response, DOR; | — |
Countries
China
Contacts
Public ContactLU WANG
Shanghai Cancer Center
Outcome results
None listed