liver cancer
Conditions
Interventions
intervention group:cryoablation +TACE combined with Camrelizumab + apatinib mesylate
Sponsors
Tianjin Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Sign written informed consent before enrollment; 2) Aged 18-75 years, male or female; 3) Patients who meet the diagnosis of primary liver cancer (HCC) as stipulated in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer 2020 (CSCO); 4) Patients who have not previously received systemic therapy, including but not limited to targeted or chemotherapy; 5) BCLC stage B or C or CNLC stage (IIb~IIIa) with at least one untreated measurable lesion (> 3cm);The sum of diameter of all lesions was = 1.5 x 10^9/L - Platelet count >= 60 x 10^9/L - hemoglobin >= 9g/dL; Liver and kidney function: - Serum creatinine (SCR) = 50 mL /min (Cockcroft- Gult formula); - Total bilirubin (TBIL) = 2+, the 24-hour urine protein quantitation must be =1g; 9) Normal coagulation function, no active bleeding and thrombosis; A. International standardized ratio INR <= 1.5 x ULN; B. Partial thromboplastin time APTT <= 1.5 x ULN; C. Prothrombin time Pt <= 1.5ulN; 10) For women of non-surgical sterilization or reproductive age, use of a medically approved contraceptive method (such as intrauterine device, birth control pills or condoms) during the study treatment period and within 3 months after the end of the study treatment period;Women of reproductive age who are not surgically sterilized must be negative for serum or urine HCG within 7 days prior to study enrolment;And must be non-lactation;Non-surgical sterilization or reproductive age male patients need to consent to the use of a medically approved method of contraception with their spouse for the duration of the study treatment period and for three months after the end of the study treatment period; 11) Subjects volunteered to participate in this study, with good compliance, safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1) Patients judged by the investigator to be unsuitable for TACE or cryoablation; 2) Complicated with hepatic encephalopathy, Gilbert syndrome, sclerosing cholangitis; 3) Patients with previous use of immune checkpoint inhibitors 4) Subjects have previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of other sites); 5) Subject is known to have a prior allergy to macromolecular protein preparation or to any drug component used in the study; 6) Subject has any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism;Subjects with vitiligo or asthma that had been in complete remission during childhood were enrolled as adults without any intervention;Asthmatic subjects requiring bronchodilators for medical intervention were not included); 7) Subjects are taking immunosuppressive, systemic, or absorbable topical hormonal therapy (>10mg/ day or other therapeutic hormone) for immunosuppressive purposes and are continuing to take it within 2 weeks prior to enrolling; 8) clinically symptomatic ascites or pleural effusion requiring therapeutic puncture or drainage; 9) Patients with clinical cardiac symptoms or diseases that are not well controlled, such as: (1) NYHA2 heart failure or above; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 10) Abnormal coagulation function (PT > 16s,APTT > 43s,TT > 21s,Fbg > 2g/L), with bleeding tendency or receiving thrombolysis or anticoagulant therapy; 11) Subjects have active infection or unexplained fever of >38.5 degrees during screening or before first administration (fever due to tumor can be included as determined by the investigator); 12) Patients with significant blood cough or daily hemoptysis of half a teaspoon (2.5 ml) or more within 2 months before the study;Or had bleeding symptoms of significant clinical significance or a definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or had vasculitis, etc., within 3 months before the study;Or arterial/venous thrombosis events occurred within 6 months prior to the study, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 13) Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary function impairment, etc.; 14) Subjects with congenital or acquired immune deficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA >= 1000 IU/ml;Reference for hepatitis C: HCV RNA >= 1000IU/ml); Chronic hepatitis B virus carriers with HBV DNA < 2000 IU/ mL must receive antiviral therapy during the trial to be enrolled. 15) Subjects are participating in other clinical studies or less than 1 month after the end of the previous clinical study;Subjects may receive other systemic antitumor therapies during the study period; 16) Live vaccine was administered less than 4 weeks before or possibly during the study period; 17) Subject has a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| CBR;OS;DCR;DoR;safety; | — |
Countries
China
Contacts
Public ContactWenge Xing
Outcome results
None listed