Liver cancer with portal vein tumor thrombus
Conditions
Interventions
Experimental group:Camrelizumab combined with apatinib and radiotherapy
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 70 years old, regardless of gender; 2. Hepatocellular carcinoma confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan >= 10mm, meeting RECIST 1.1 standard); 3. Imaging examination confirmed the presence of portal vein tumor thrombus; 4. Clinical assessment cannot tolerate radical surgical resection; 5. Expected survival time > 3 months; 6. ECOG PS score: 0-1 points; 7. Child-Pugh liver function score: Grade A or better Grade B (= 1.5 x 10^9/L; platelets >= 80 x 10^9/L; hemoglobin >= 9g/dL; 2) Thyroid-stimulating hormone (TSH) <= 1 times ULN (if abnormal, the T3 and T4 levels should be examined at the same time, if the T3 and T4 levels are normal, they can be included in the group); 3) Bilirubin <= 1.5 times ULN; ALT and AST <= 5 times ULN; 4) Serum creatinine <= 1.5 times ULN. 11. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use effective contraceptive measures uninterruptedly during treatment and 6 months after the last treatment dose; 12. The subject voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding, or have fertility but refuse to take contraceptive measures; 2. History of other malignant tumors in the past 5 years; 3. Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 4. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severely impaired lung function; 5. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss) Can be selected 6. Patients with active hepatitis B or C, and chronically infected patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) with a viral load of less than 1000IU/mL are allowed to participate in the study, but need to continue during the study period Or start full-course standardized antiviral treatment; 7. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery; 8. Severe active infections that require intravenous antibiotic treatment occurred during the enrollment period; 9. Those who are allergic to test drugs; 10. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Carrelizumab; 11. Known history of HIV infection; 12. Active bleeding or abnormal blood coagulation (PT>16s, APTT>43s, INR>1.5 x ULN), or there is bleeding or thrombolysis, anticoagulation or antiplatelet therapy tends to have moderate or above pleural and clinical symptoms ascites; 13. A history of gastrointestinal bleeding or bleeding tendency within 6 months before admission; 14. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, which can seriously affect the use and absorption of medications); 15. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 16. The researcher thinks it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS; | — |
Countries
China
Contacts
Public ContactYu Han
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed