hepatocellular carcinoma with portal vein tumor thrombus
Conditions
Interventions
SBRT group:Camrelizumab, Apatinib methanesulfonate combined with radiotherapy
Non-SBRT group:Camrelizumab combined with apatinib mesylate
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients volunteered to join the study and signed an informed consent form; 2. Aged >= 18 years, both male and female; 3. HCC patients diagnosed by histopathology, cytology or clinical diagnosis; 4. II or III or IV type with portal vein tumor thrombus; 5. For patients who progressed after local treatment, local treatment (including, but not limited to, surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) was completed at least 4 weeks before baseline imaging scan. The toxic reactions caused by local treatment (except alopecia) must be restored to the National Cancer Institute-Standard for adverse events version 4.03 (NCICTCAE v4.03) rating = 15 mm;). Lesions that have received local treatment in the past can be used as target lesions after definite progress according to RECIST v1.1 standard); 8. Child-Pugh liver function classification: grade A or B; 9. ECOG score: 0: 1 (ECOG scoring standard); 10. The expected survival time was >= 12 weeks; 11. The function of the main organs meets the following requirements (within 7 days prior to the commencement of the study): (1) Blood routine examination: (except hemoglobin, no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no drug correction within 14 days before screening): The absolute count of neutrophils >= 1.5 x 10^9; Platelet >= 75 x 10^9; Hemoglobin >= 90g; (2) biochemical examination: (albumin was not infused within 14 days before screening): Serum albumin >= 29g; Upper limit of serum total bilirubin 50 mL/min (Cockcroft-Gault formula below); Male: Cr clearance rate = (140-age) x body weight / (72 x blood Cr); Female: Cr clearance rate = (140-age) x body weight / (72 x blood Cr) x 0.85; Unit of body weight: kg; blood Cr unit: mg/mL; (3) the international standardized ratio (INR) = 2, 24-hour (h) urinary protein quantification can be performed, and 24-hour urinary protein quantification < 1.0g can be entered into the group). 12. If the patient has active hepatitis B virus (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be less than 500 IU/mL (if the research center has only copy/mL testing units, it must be < 2500copy/ml). And receive at least 14 days of anti-HBV therapy (according to local standards, such as entecavir) before the start of the study and are willing to receive antiviral therapy throughout the study period. Patients with hepatitis C virus (HCV) ribonucleic acid (RNA) positive must receive antiviral therapy according to the local standard treatment guidelines and the liver function is within CTCAE grade 1; 13.Women with fertility must agree to avoid heterosexual intercourse, or use reliable and effective methods of contraception from signing the informed consent form until at least 120 days after the last administration of the study drug. And the serum
Exclusion criteria
Exclusion criteria: 1. Hepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrous lamellar cell carcinoma are known, and active malignant tumors other than HCC are found within 5 years or at the same time. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. 2. Patients who are ready to undergo or have previously received organ or allogeneic bone marrow transplantation; 3. The patients with moderate or severe ascites with clinical symptoms needed therapeutic puncture, drainage or Child-Pugh score > 2 (except for those who showed a small amount of ascites but no clinical symptoms). Uncontrolled or moderate or above pleural effusion, pericardial effusion; 4. Within 6 months before the start of the study, there was a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding. For example, if there is a risk of bleeding or severe esophageal and gastric varices, lesions with locally active gastrointestinal ulcers, and persistent positive fecal occult blood is not allowed in the group (if fecal occult blood is positive in the baseline period, it can be reexamined, and if it is still positive after reexamination, If gastroduodenoscopy was needed, (EGD), could not be enrolled if EGD suggested esophageal and gastric varices at risk of bleeding); 5. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred in 6 months before the beginning of the study; 6. Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendencies, such as hemophilia; Full-dose oral or injection of anticoagulant or thrombolytic drugs for therapeutic purposes (prophylactic use of low-dose aspirin, low molecular weight heparin) is currently under way or in the near future (within 10 days before the start of the study); 7. Aspirin (> 325mg/ days (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel and cilostazol were currently being used or recently used (within 10 days before the start of the study) or treated with dipyridamole, ticlopidine, clopidogrel and cilostazol; 8. Thrombosis or embolism occurred within 6 months before the beginning of the study, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism and so on; 9. Having clinical symptoms or diseases of the heart that are not well controlled, such as: (1) in accordance with (NYHA) standards of the New York Heart Association, Left ventricular ejection fraction: LVEF 450ms (male); QTc > 470ms (female) (QTc interval was calculated by Fridericia formula; if QTc was abnormal, it could be detected three times at an interval of 2 minutes, and its average value could be taken); 10. Patients with hypertension, and after antihypertensive drug treatment can not be well controlled (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg) (based on the average of BP readings measured >= 2 times), allowing the use of antihypertensive therapy to achieve these parameters; Hypertension crisis or hypertensive encephalopathy occurred in the past; 11
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Over all survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease control rate (DCR);Progression-free survival (PFS);Time to progression;Duration of Response;Toxic and side effects; | — |
Countries
China
Contacts
Public ContactXue Jun, Zhang Tao
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed