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| Name | Class |
|---|---|
| Chinese Society of Clinical Oncology | OTHER |
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Apatinib and SHR-1210 are new drugs produced by jiangsu hengrui pharmaceutical co., LTD. Both are listed in China. The investigators want to design a trial to explore the efficacy and safety of Apatinib and SHR-1210 in patients with solid tumors with only liver metastasis (as second-line treatment). The main purpose is to evaluate the disease progression-free survival (PFS) of Apatinib and SHR-1210 in patients with solid tumors with only liver metastasis (progress after first-line treatment). The secondary purpose is to compare the total survival period (OS); 1-year survival rate, 2-year survival rate; evaluation of drug safety; exploration of related biomarkers in specific subgroups to predict effectiveness or adverse reactions.
Any solid tumor in the presence of liver metastasis indicates poor prognosis, short overall survival, immunotherapy combination with anti-tumor angiogenesis agents have some curative effection according to recent studies. It seems there has been clinical evidence to improve the immune microenvironment of the tumor, while in the case of only liver metastasis, the tumor's characteristics may not be consistent with other tumors. This study was to investigate the efficacy and safety of such patients by combining Apatinib and SHR-1210. This study will include approximately 20 patients with solid tumors with only liver metastases (progression after first-line treatment). The investigators will evaluate the efficacy and safety of Apatinib combined with SHR-1210 in these patients. If possible we would check the patients' ctDNA and some infection factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| solid tumor with only liver metastases after first line treatment | Experimental | Apatinib 250mg, Qd, oral administration,SHR-1210 200mg, q3w one week later, intravenous administration, continuous administration until the disease progresses or an intolerable adverse reaction occurs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib and Camrelizumab for Injection | Drug | Apatinib 250mg, Qd, oral administration,SHR-1210 200mg, q3w one week later, intravenous administration, continuous administration until the disease progresses or an intolerable adverse reaction occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | From date of registration until the date of disease progresssion or death resulting from any cause. | Patients will be followed for an average period of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | From date of registration until the date of death from any cause or the last follow-up visit. | Patients will be followed for an average period of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year survival rate | Percentage of patients alive at 1 year. | 12 months |
| 2-year survival rate | Percentage of patients alive at 2 year. | 24 months |
Inclusion Criteria:
6) expected survival period ≥3 months; 7) women of child-bearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the result is negative, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last dose of the test drug.For men, either surgical sterilization or consent to appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; 8) subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingying Huang | Contact | 86-10-85136715 | xiaoyudianhh@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingying Huang | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| C000631724 | camrelizumab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Safety and tolerability as measured by number and grade of toxicity events | Overall Safety Profile by CTCAE V4.0 | 12 months |
| Beijing Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100730 | China |
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