Liver cancer
Conditions
Interventions
Experimental group:Camrelizumab combined with apatinib mesylate and radiotherapy
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with advanced hepatocellular carcinoma diagnosed by pathology or clinical diagnosis; 2. The clinical stage is IIIa-IV; 3. Have received at least one systemic treatment failed or intolerable in the past; 4. Have not used PD-1 antibody before; 5. With measurable tumor lesions (spiral CT scan >= 10mm, meeting RECIST 1.1 standard); 6. Expected survival time > 3 months; 7. Age: 18 to 70 years old, no gender limit; 8. ECOG PS: 0-2 points; 9. Child-Pugh is classified as Class A; 10. The damage caused by the subject receiving other treatments has been restored; 11. The functions of important organs meet the following requirements: a) Absolute neutrophil count >= 1.5 x 10^9/L, platelet >= 100 x 10^9/L, hemoglobin >= 9g/dL; b) Bilirubin 60 mL/min; 12. 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 contraception during treatment and 6 months after the last treatment dose. 13. The patient voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. The weight loss of the patient exceeds 30% of the original weight; 2. There are complications that need to be treated, such as ascites or pleural effusion with clinical symptoms, that requires therapeutic puncture or drainage; 3. Suffer from other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 4. There is active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before medication should be excluded even if they have been treated. Patients with a history of active pulmonary tuberculosis infection more than 1 year ago should also be excluded, unless it is proven that they have previously received standard anti-tuberculosis treatment; 5. People with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 6. Patients with active hepatitis B or C, chronically infected 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 or start full-course standardized antiviral treatment during the study period; 7. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only requires 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; 9. People with high blood pressure who cannot be well controlled by a single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 10. Inability to swallow pills, malabsorption syndrome or any condition that affects gastrointestinal absorption; 11. Have significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before the first time, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above, or suffering from vasculitis, etc.; 12. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up; 13. Has a history of psychotropic drug abuse, alcohol or drug abuse; 14. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 15. The researcher believes that it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactChunbo Zhao
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed