hepatocellular carcinoma
Conditions
Interventions
Treatment group:Radiation therapy + carrellizumab + apatinib
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance; ? Age = 18 years old, = 70 years old, male or female; ? BCLC stage B-C hepatocellular carcinoma confirmed by clinical or pathological examination, unable/unwilling to undergo surgical treatment due to various reasons; ? Have not received any systemic antitumor therapy in the past, surgery/radiofrequency ablation/TACE is allowed, or there is tumor recurrence or metastasis confirmed by imaging and pathology after previous treatment; ? There is at least one assessable tumor, and the intrahepatic tumor is the primary tumor; ? The diameter of the tumor is less than or equal to 7cm; the number of tumors can be screened and adjusted according to the patient's liver function and radiotherapy tolerance; ? It may be accompanied by portal vein cancer thrombosis or lymph node metastasis (excluding VP3 and VP4 types); ?Child-Pugh score = 7 points (Child-Pugh A-B); ?ECOG score: 0 to 1; ?The liver tumor burden does not exceed 50% of the total liver volume; ?The patient can swallow tablets normally; ?Expected survival of more than 12 weeks; ?Laboratory parameters meet the following requirements (blood components and cell growth factors are not allowed within 14 days prior to first administration): A. The absolute count of neutrophils (NEUT) = 3.0 × 109/L; B. Platelets (PLT) = 80 × 109/L; C. Hemoglobin (HGB) = 90g/L; D. Serum albumin = 28g/L; E. Thyroid stimulating hormone (TSH) = 1 × ULN (if abnormal, FT3, FT4 levels should be considered at the same time, and patients with FT3 and FT4 levels within the normal range can also be enrolled); F. Bilirubin = 1.5 × ULN (within 7 days before the first dose); ALT = 3 x ULN and AST = 3 x ULN (within 7 days before the first dose); H. AKP = 2.5 × ULN; Serum creatinine = 1.5 × ULN; ?For women of non-surgical sterilization or childbearing age, the use of a medically approved contraceptive (such as an IUD, contraceptive, or condom) is required during the study period and within 3 months of the end of the study treatment period; for women of non-surgical sterilization or childbearing age, a serum or urine HCG test must be negative within 72 hours prior to study enrollment; and must be non-lactation; for male patients of significant other reproductive age, an effective method of contraception should be administered during the trial period and at the end of the carrellizumab injection.
Exclusion criteria
Exclusion criteria: ? The patient has received any previous systemic therapy, such as chemotherapy, anti-PD-1 antibody therapy, or other immunotherapy targeting PD-1/PD-L1, or has previously received apatinib; ? History of radiation therapy 6 months before the first treatment; ? Severe allergic reaction to other monoclonal antibodies; ? Participate in other clinical trials within 4 weeks before participating in the study; ? Patients with clinically symptomatic ascites who need puncture, drainage or ascites drainage within 3 months, except for those with small amount of ascites but no clinical symptoms; ?Live vaccination received less than 4 weeks prior to the study or possibly during the study period; ? Complicated diseases and medical history: A. Concomitant hepatic encephalopathy; B. The patient has other malignant tumors in the past 3 years or at the same time; C. Have a history of organ transplantation; D. Coagulation dysfunction (INR > 2.0, PT > 16s), tendency to bleed, or receiving thrombolytic or anticoagulant therapy (still used within 7 days prior to treatment initiation) E. Significant clinically significant bleeding symptoms or significant bleeding tendencies within 3 months prior to enrollment, such as daily hemoptysis of more than 2.5 ml, gastrointestinal bleeding, esophageal varices at risk of bleeding, bleeding gastric ulcers or vasculitis, etc. If gastroscopy shows severe esophageal varices or other high-risk bleeding conditions considered by the investigator, you cannot be enrolled unless a gastroscopy has been performed within one month or less to rule out such cases; F. Arterial/venous thrombosis events that occurred within the 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; G. Known hereditary or acquired bleeding and susceptibility to thrombosis (eg, hemophilia, coagulation disorders, thrombocytopenia, etc.); H. The patient has any history of active autoimmune disease or autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pitulitis, vasculitis, nephritis, hyperthyroidism; vitiligo). For patients with a history of asthma, complete remission of childhood asthma without any intervention in adulthood may be included, while those with asthma requiring medical intervention with bronchodilators may not be included. I. The patient is immunosuppressed with immunosuppressants or systemic hormone therapy (doses > 10 mg/day of prednisone or other therapeutic hormones) and continues to use it for 2 weeks prior to enrollment; ?The presence of any severe and/or uncontrolled disease, including: A. Suffering from hypertension and poor blood pressure control (systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg); B. Poor glycemic control (fasting blood glucose (FBG) > 10 mmol/L); C. The patient has an active infection, unexplained fever (= 38.5 ° C) within 7 days prior to administration, or a baseline white blood cell count > 15 × 109/L; D. Renal failure requires hemodialysis or peritoneal dialysis; E. People with neurosyphilis; F. Patients with congenital or acquired immunodeficiency (such as HIV-infected patients); G. Those with epilepsy and in need of treatment; H. Suffering from clinically symptomatic or poorly controlled heart disease, such
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate(DCR);Progression-free survival(PFS);Overall survival(OS);Adverse event(AE); | — |
Countries
China
Contacts
Public ContactLi Jiqiang
Zhujiang Hospital of Southern Medical University
Outcome results
None listed