Advanced hepatocellular carcinoma
Conditions
Interventions
To be treated by hypofractionated radiotherapy plus sintilimab plus bevacizumab biosimilar:N/A
Sponsors
The Fifth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Voluntarily signed the informed consent to participate in this observational study. (2) 18 years=Age=65 years. (3) Patients with hepatocellular carcinoma diagnosed pathologically or clinically based on the American Association for the Study of Liver Diseases practice guideline. (4) Staged as Barcelona Clinic Liver Cancer B or C. (5) Child-Pugh class A liver function. (6) Eastern Cooperative Oncology Group performance status of 0-1. (7) Ineligible or unwilling to undergo surgical resection, HAIC or TACE after MDT discussion. (8) With measurable lesions confirmed by CT or MRI according to RECIST V1.1, which should not have received radiotherapy. (9) Toxicity should recover to =grade 1 (according to NCI-CTCAE v5.0 criteria) if patients had received anti-tumor treatment. (10) Life expectancy =12 weeks. (11) Adequate organ function: a. Blood routine examination (no blood transfusions, no hematopoietic stimulators, or no other medications to correct blood counts was administered within 14 days prior to initial treatment): absolute neutrophil count=1.5×10^9/L, platelet count=75×10^9/L, hemoglobin=90 g/L. b. Blood biochemistry: serum creatinine =1.5 upper limit of normal (ULN) or creatinine clearance rate =50mL/min, total bilirubin=1.5 ULN, alanine transaminase and aspartate transaminase=2.5 ULN. c. Coagulation function (no anticoagulant or other medication correction affecting clotting within 14 days prior to initial study administration, except in the case of long-term anticoagulant use due to the subjects' disease): activated partial thrombin time (APTT) and international standardized ratio (INR) =1.5 UNL. (12) Females of childbearing age should be confirmed non-pregnant by a negative urine or serum pregnancy test within 3 days prior to receiving study treatment (on day 1 of 1st cycle). If a urine pregnancy test result can not be confirmed negative, a blood pregnancy test is required. Women of non-productive age were defined as postmenopausal for at least 1 year, or who had undergone surgical sterilization or hysterectomy. (13) Patients should use adequate contraceptive measures from the time they signed the informed consent form to 6 months after the final treatment (failure rate <1%).
Exclusion criteria
Exclusion criteria: (1) With uncontrollable allergic asthma and/or a history of allergy to sintilimab and/or bevacizumab and/or their excipients. (2) With other malignancies that have progressed or require treatment within 5 years before enrollment screening (excluding fully treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or cured carcinoma in situ, such as carcinoma in situ of the breast, etc.) (3) Patients with active autoimmune disease or a history of autoimmune disease, but allow further screening for patients with well-controlled type 1 diabetes mellitus, well-controlled thyroid function regression by hormone replacement therapy, and skin disease that does not require systemic treatment (eg, vitiligo, psoriasis, or alopecia), or patients whose disease will not recur in the absence of external triggers. (4) History of primary immunodeficiency. (5) With Severe cardiovascular disease, including but not limited to: New York Heart Association (NYHA) grade 2 and above heart failure; and viral myocarditis, myocardial infarction, poorly controlled heart rhythm and unstable angina pectoris within 3 months prior to screening; severe arterial/venous events (such as transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism, etc.) within 3 months before screening; cardiac ejection fraction below 50% or the lower limit of the reference range for laboratory tests in the study center; persistent cardiomyopathy, QTc >450 millisecond, or congenital long QT syndrome. (6) Patients with interstitial lung disease (except for localized interstitial pneumonitis induced by radiotherapy) and non-infectious pneumonitis requiring glucocorticoid therapy. (7) With a history of active tuberculosis. (8) Patients with untreated central nerve system metastases, or treated but still symptomatic central nerve system metastases (except for residual signs or symptoms associated with central nerve system treatment, those with stable or improved neurological symptoms at least 2 weeks prior to screening can also be enrolled). (9) A history of immune-related adverse events =grade 3 according to NCI-CTCAE v5.0 while receiving immunotherapy in the past. (10) A history of major surgery or radical radiotherapy within 28 days before this study treatment; or palliative radiotherapy within 14 days before the study treatment; or radiopharmaceuticals (strontium, samarium, etc.) within 56 days before the study. (11) A history of receiving systemic anti-tumor therapy 28 days before the study, including but not limited to chemotherapy, immunotherapy, target therapy, biological therapy (tumor vaccines, cytokines, or growth factors). (12) Patients who had received or planned to receive live attenuated vaccine within 28 days before the study. (13) A history of receiving NMPA-approved drug of Chinese patent medicines with anti-tumor-related functions and indications (including Compound Banthari Capsules, Kangai Injection, Kanglaite Capsules/Injections, Aidi Injections, Brucei Oil Injections/capsules, Xiaoaiping tablets/injections, cinobufacini capsules, etc.) or Chinese herbal medicines for the purpose of anti-tumor within 14 days before the study. (14) Any active infection requiring systemic therapy by intravenous infusion of antibiotics within 28 days prior to this study. (15) Receiving glucocorticoid (prednisone >10mg/day or other similar drugs at an equivalent dose) or other immunosupp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;Duration of overall response; | — |
Countries
China
Contacts
Public ContactHongyu Zhang
The Fifth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed