hepatic carcinoma
Conditions
Interventions
treatment group:SBRT and Anlotinib Hydrochloride combined with Toripalimab
Sponsors
The 900th Hospital of The Joint Logistic Support Force of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years old, ECoG PS score: 0-1, estimated survival time more than 3 months; 2. Child Pugh liver function grade: A or B (= 3.0 x 10^9 / L; ANC >= 1.5 x 10^9 / L; PLT >= 90 x 10^9 / L; Hgb >= 9.0 g / dl; (2) Liver function: TBIL = 50 ml / min; (4) Coagulation function: INR <= 1.5, APTT <= 1.5 x ULN; 8. The quantity of HBV-DNA was less than 500iu / ml (2500 copies / ml), and received anti HBV treatment at least 14 days before the start of the test and was willing to continue antiviral treatment during the study period; the patients with positive quantity of HCV-RNA needed to receive antiviral treatment and their liver function was within nci-ctcae grade 1; 9. Women of childbearing age must carry out the study of serum pregnancy within 2 weeks before the first drug use, and the result is negative. Women of childbearing age and male subjects with partners of women of childbearing age were required to use contraception during the study and within 180 days after the last administration of the study drug; 10. The subjects volunteered to join the study, signed the informed consent, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who are known to have fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC with bleeding or who are at high risk of bleeding, untreated or untreated varices, must undergo gastroduodenoscopy (EGD) prior to enrollment, must assess the size of all varices (small to large), and must be treated according to local standards. Patients who had received EGD within 6 months prior to the start of the study did not need to repeat the microscopy; 2. Patients who have used anti angiogenic drugs such as enrotinib hydrochloride capsules, apatinib mesylate tablets, lovatinib mesylate capsules, sorafenib mesylate tablets, sunitinib malate capsules, bevacizumab or immunotherapy drugs such as PD-1 and PD-L1 before; 3. Patients with other malignant tumors (except for cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) within 5 years; 4. Patients with any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthmatic patients who need medical intervention of bronchodilator can not be included); but the following patients are allowed to join the group: vitiligo, psoriasis, psoriasis without systemic treatment Hair loss, good control of type I diabetes, thyroid function normal hypothyroidism by replacement therapy; 5. Patients with uncontrolled hypertension were treated with standard therapy (blood pressure was not stable below 150 / 90 mmHg); 6. Patients with any physical signs or history of bleeding, regardless of the severity; within 4 weeks before the first administration, any bleeding or bleeding event >= CTCAE 3 Patients of Grade A, or patients with digestive tract diseases such as unhealed wound, fracture, gastric and duodenal active ulcer, ulcerative colitis, or patients with active bleeding due to unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation determined by researchers; 7. Patients with definite or suspected brain metastasis. Patients with previous history of brain metastasis must have completed treatment, and patients who no longer need corticosteroid treatment can be included in the group; 8. Patients with clinical symptoms or diseases of heart that can not be well controlled, such as: (1) heart failure above NYHA Level 2; (2) unstable angina pectoris; (3) myocardial infarction within 24 weeks; (4) clinically significant supraventricular or ventricular arrhythmias that need treatment or intervention; 9. Patients with clinically uncontrollable third space effusion (such as pleural effusion / pericardial effusion, patients who do not need drainage of effusion or stop drainage for 3 days without significant increase of effusion can be included in the group); 10. Imaging (CT or MRI) shows that the tumor invades the large blood vessels or the researcher judges that during the follow-up study, the tumor is likely to invade the important blood vessels and cause fatal bleeding; 11. Patients with a history of immunodeficiency, including HIV positive, or with other acquired or congenital immunodeficiency diseases, or with a history of organ transplantation and allogeneic bone marrow transplantation; 12. Patients with active hepatitis B (defined as those with positive HBsAg test results and HBV-DNA test values higher than the upper limit of normal values in the laboratory of the research center) or hepatit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| one-year survival rate;two-year survival rate;objective remission rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactYonghai Peng
The 900th Hospital of the Joint Logistic Support Force of PLA
Outcome results
None listed