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Literature has shown that radiotherapy can promote tumor antigen presentation, mobilize and activate T cells by enhancing activation signals and blocking inhibitory signals. It can also lead to the normalization of blood vessels in the tumor microenvironment and the increase of CXCL16 and other chemokines to activate T cells. The cells infiltrate the tumor tissues better and promote the killing activity of T cells. Therefore, the combined application of radiotherapy and immunotherapy may have a synergistic effect. Apatinib is a small molecule tyrosine protein kinase inhibitor for VEGFR. Low-dose apatinib can induce the normalization of abnormal blood vessels in tumors, effectively increase the infiltration of lymphocytes in tumor tissues, and block immunosuppressive myeloid cells. Recruitment, reverse the immunosuppressive state, effectively reduce the level of TGF-β, and make the tumor environment tend to have an immune support phenotype. Apatinib combined with PD-1 antibody karelizumab has been confirmed in a phase I study to have good efficacy and safety in patients with advanced liver cancer. Therefore, this study intends to use the PD-1 antibody carrelizumab combined with apatinib and radiotherapy to treat patients with advanced liver cancer with extrahepatic metastasis, to evaluate the effectiveness and safety of the combined therapy, and to provide new clinical treatments for liver cancer Evidence-based medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carrelizumab treatment group started during radiotherapy | Experimental |
| |
| Start the carrelizumab treatment group within 3 days after the | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab Apatinib Mesylas | Drug | This study intends to use the PD-1 antibody carrelizumab combined with apatinib and radiotherapy to treat patients with advanced liver cancer with extrahepatic metastasis |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Time from treatment start to disease progression or death from any cause | 24months |
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Inclusion Criteria:
1. Age: ≥18 years old, male or female; 2. Patients with hepatocellular carcinoma diagnosed by imaging examination or pathology; 3. Not suitable for surgical resection or local treatment, patients with lymph or lung metastasis; 4.Child-Pugh score: Grade A, normal liver volume (liver volume-gross tumor volume) > 700 ml; 5. The ECOG score is 0-1 within one week before entering the group; 6. There is at least one measurable lesion that meets the mRECIST and RECIST 1.1 standards; 7. The expected survival time is ≥3 months; 8. The main organs function normally, that is, they meet the following standards:
10. Women of childbearing age (generally 15-49 years old) must have a negative pregnancy test (serum or urine) within 14 days before entering the group, and voluntarily adopt appropriate methods of contraception during the observation period and within 8 weeks after the last administration of research drugs; For men, they should be sterilized by surgery or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of study drugs.
11. The subjects voluntarily joined the study, signed the informed consent form, and had good compliance and cooperated with the follow-up.
Exclusion Criteria:
(1) Active peptic ulcer lesions; (2) Those who have a history of black stool and hematemesis within 3 months; (3) For fecal occult blood (+) or (+/-), it needs to be reviewed within 1 week, and gastroscopy should be performed if it is still (+) or (+/-). If there is ulcer or hemorrhagic disease, and the attending doctor thinks there is potential bleeding risk; 15. Arterial/venous thrombosis events occurred within 6 months before entering the study, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism, etc.; 16. Infections requiring drug intervention within 4 weeks before the first administration (such as intravenous drip of antibiotics, antifungal or antiviral drugs), or fever of unknown cause > 38.5°C; during screening/before the first administration; 17. Participated in any other drug clinical research within 4 weeks before the first administration; 18. It is known that there is a history of psychotropic drug abuse or drug abuse; 19. There are other serious physical or mental diseases or abnormal laboratory examination, which may increase the risk of participating in the study, or interfere with the results of the study, and the researchers think that the patients are not suitable for participating in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gong Li, Master | Contact | 13366061906 | dr_gongli@163.com |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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