Exophthalmic malignancies
Conditions
Interventions
Experimental group A:Intravenous injection of camrelizumab + Oral administration of apatinib mesylate
Sponsors
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The patients voluntarily joined the study and signed the informed consent; 2.Age: >= 18 years old, male or female; 3.Locally advanced or metastatic exophthalmic solid malignant tumors confirmed by histopathology: ocular melanoma (conjunctival melanoma, eyelid melanoma, etc.), ocular squamous cell carcinoma (eyelid squamous cell carcinoma, conjunctival squamous cell carcinoma, etc.), eyelid sebaceous carcinoma, orbital sarcoma (mesodermal origin, including bone, cartilage, muscle, blood vessel, fiber, fat, etc.), other types (lacrimal adenoid cystic carcinoma, Merkel cell carcinoma). And one of the following requirements should be met: (1)the standard treatment scheme is invalid; (2)there is no standard treatment scheme; (3)the attending doctor thinks that the standard treatment scheme is not applicable; 4.At least one measurable lesion in accordance with RECIST v1.1; 5.ECOG PS score: 0-1; 6.The function of main organs was normal; 7.Women of childbearing age must have a negative pregnancy test within 7 days before enrollment, and voluntarily use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of the study drug; 8.Patients with hepatitis B virus infection: HBV-DNA must be less than 2000 IU / ml, and they should receive anti HBV treatment for at least one week before entering the group, and they are willing to receive antiviral treatment throughout the study period; patients with hepatitis C virus RNA positive must receive anti viral treatment according to the treatment guidelines, and their liver function should be within CTCAE level 1; 9.Patients with good compliance are expected to follow up the efficacy and adverse reactions according to the protocol requirements; 10.Non lactation patients.
Exclusion criteria
Exclusion criteria: 1.Those who participated in other clinical trials or were participating in other clinical trials within 4 weeks before the trial; 2.Patients with central nervous system disease or brain metastasis; 3.Patients in immunosuppressive state or receiving systemic steroid or other immunosuppressive therapy within 7 days before the trial; 4.There are other known progressive malignant tumors that need active treatment; 5.Patients with active autoimmune diseases requiring systemic treatment, patients with clinical history of severe autoimmunity, and patients with symptoms requiring systemic steroid or immunosuppressive therapy in the past three months; 6.Active infected persons who need systematic treatment; 7.Schizophrenics and drug abuse disorders may not cooperate with the trial; 8.Pregnant or lactating women. 9.There are clinical symptoms or diseases of heart that can not be well controlled; 10.Patients with hypertension who can not be reduced to normal after antihypertensive drug treatment; 11.Patients with diabetes who can not be reduced to normal after diet and hypoglycemic treatment; 12.There are many factors affecting the absorption of oral drugs; 13.Patients with risk of gastrointestinal bleeding were not included; 14.Abnormal coagulation function and bleeding tendency; 15.Obvious cough blood or half teaspoon (2.5ml) or more of hemoptysis was found in 2 months before screening; 16.The imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was highly likely to invade the important blood vessels during the treatment, causing fatal massive hemorrhage; 17.Thrombosis or embolism occurred within 6 months before the start of the study; 18.Patients with interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia that may interfere with the judgment and treatment of immune related pulmonary toxicity, or evidence of active pneumonia on screening chest computed tomography (CT) Or subjects with severe impairment of lung function; 19.Active autoimmune disease or history of autoimmune disease with possible recurrence; 20.Immunosuppressive agents or systemic hormones were used 14 days before the start of the study; 21.Strong CYP3A4 / CYP2C19 inducers, including rifampicin or strong CYP3A4 / CYP2C19 inhibitors, were used 14 days before the start of the study; 22.Known to have a history of severe allergy to any monoclonal antibody or antiangiogenesis targeting drug; 23.Uncontrollable infection occurred during screening; 24.Patients considered unsuitable by other doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Duration of Response;Tumor transformation and resection rate;Objective Response Rate;Overall Survival;Disease Specific Survival;Vision;Visual field;Intraocular pressure;Exophthalmos;Eye salvage rate;Incidence and severity of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactFan Xianqun
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed