Giant liver cancer
Conditions
Interventions
experimental group:Camrelizumab + oral targeted preparation + TACE plus radioactive seed strip implantation
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Clinically diagnosed hepatocellular carcinoma with measurable tumor lesions (spiral CT or MR scan >=10mm, meeting the RECIST 1.1 standard); 3. The diameter of a single tumor is greater than or equal to 10 cm, or the maximum diameter of multiple tumors is greater than 7 cm; 4. Clinical assessment cannot tolerate radical surgical resection; 5. Expected survival time> 3 months; 6. ECOG PS score: 0-2 points; 7. Child-Pugh liver function score: Grade A or better Grade B (=1.5x10^9/L; platelets>=80x10^9/L; hemoglobin>=9g/dL; 2) Thyroid-stimulating hormone (TSH) <=1 ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group); 3) Bilirubin <=1.5 ULN; ALT and AST <=5 ULN; 4) Serum creatinine <=1.5 ULN; 10. Women of childbearing age must take a negative pregnancy test (beta HCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to have effective contraceptive measures during treatment and 6 months after the last therapeutic dose; 11. 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. Patients with extrahepatic metastases; 3. Suffered from other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or skin squamous cell carcinoma, or skin basal cell carcinoma that has been basically controlled; 4. Active bleeding or abnormal blood coagulation (PT > 16s, APTT > 43s, INR > 1.5 ULN), or bleeding or thrombolysis, anticoagulation or antiplatelet therapy, moderate or above pleural and clinical symptoms ascites; 5. People with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 6. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severely impaired lung function; 7. 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; 8. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery; 9. Severe active infections that require intravenous antibiotic treatment occurred during the enrollment period; 10. Those who are allergic to test drugs; 11. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Carrelizumab; 12. Known history of HIV infection; 13. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, which will seriously affect the use and absorption of medications); 14. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 15. The researcher believes that it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS;Safety; | — |
Countries
China
Contacts
Public ContactXiaoli Wei
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed