Liver cancer
Conditions
Interventions
case series:camrelizumab combined with stereotactic radiotherapy
Sponsors
Nanjing General Hospital of Nanjing Military Command
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Patients with advanced hepatocellular carcinoma diagnosed by pathology have previously received at least one systemic treatment failure or intolerance, unsuitable for surgery and local treatment (definition of treatment definition: toxic side effects are intolerable, treatment Progression of the disease during the course or disease progression within 3 months after the last treatment); Note: a. Treatment of each line of advanced disease includes one or more medications with a dose of >= 1 cycle or longer. b. Allow pre-treatment is chemotherapy combined with targeted drugs. (2) Imaging confirmed the presence of portal vein tumor thrombus, combined with intrahepatic lesions, and no extrahepatic metastases. According to RECIST 1.1, patients have at least one target lesion that can measure the diameter. (3) Age: 18 to 70 years old; (4) ECOG PS score: 0~1 points; Child-Pugh A or B (= 3 months; (6) The damage caused by the subject receiving other treatment has been restored; (7) Signing an informed consent form; (8) Compliance is good and can be followed up.
Exclusion criteria
Exclusion criteria: (1) Except for other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ. (2) Subjects who had received anti-PD-1 (L1) or CTLA4 mAb treatment. (3) combined extrahepatic metastasis. (4) imaging examination indicates that the tumor burden is too high: liver tumor load >50%. (5) The main organ function is abnormal, that is, the relevant inspection indicators reach the following levels: Blood test: a. HB = 1.25 × ULN (upper normal limit); b. ALT or AST >= 1.5 × ULN; if there is liver metastasis, ALT or AST >= 2.5 × ULN; c. Endogenous creatinine clearance 1.5 × ULN; triglycerides > 2.5 × ULN; Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to initial use. (7) Subjects who have received anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects within 1 month prior to the first dose. (8) Vaccinated or vaccinated within 1 month before the first dose. (9) Those who have hypertension and cannot be well controlled by a single antihypertensive drug (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), myocardial ischemia or myocardial infarction, myocardial infarction, arrhythmia and cardiac insufficiency of grade II or higher; (10) Subjects who have experienced severe infections within 4 weeks prior to the first dose or subjects with any active infection. (11) Women who are pregnant or lactating or women/men who are ready to give birth. For female subjects: Should be surgical sterilization, postmenopausal patients, or consent to use a medically approved contraceptive (such as intrauterine device [IUD], birth control pills or condoms during study treatment and 6 months after the end of the study treatment period) The serum or urine pregnancy test must be negative within 7 days prior to study enrollment and must be non-lactating. Male subjects: should be surgically sterilized, or consent to use a medically approved contraceptive during the study treatment and within 6 months of the end of the study treatment period. (12) In the past, there was abnormal thyroid function, and even in the case of medical treatment, thyroid function could not be maintained within the normal range; (13) Those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; (14) Participated in other drug clinical trials within four weeks; (15) Ascites with clinical symptoms and requiring clinical intervention; (16) A history of immunodeficiency, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; (17) According to the investigator's judgment, there are serious concomitant diseases that endanger the safety of the patient or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;AE; | — |
Countries
China
Contacts
Public ContactXiangdong Sun
Outcome results
None listed