melanoma
Conditions
Interventions
Trial group:Combination of Carilizumab with Apatinib Mesylate and Radiotherapy
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years (inclusive) at screening; either sex acceptable. 2. Histopathologically confirmed mucosal melanoma that is recurrent after surgery, unresectable, or metastatic. 3. No prior systemic anti-tumor therapy in the advanced/metastatic setting. Prior (neo)adjuvant therapy is permitted if completed >=4 weeks before randomization and all related toxicities have resolved to baseline or =10 mm by spiral CT/MRI or >=15 mm short-axis for lymph nodes). 5. At least one lesion deemed amenable to radiotherapy. 6. ECOG performance status 0 or 1. 7. Life expectancy >=12 weeks. 8. No contraindications to study therapy and adequate organ/bone-marrow function: (1) Absolute neutrophil count >=1.5 × 10?/L (2) Platelet count >=80 × 10?/L (3) Hemoglobin >=90 g/L (4) ALT and AST =3 months before study entry. Corticosteroids for CNS disease are permitted if discontinued >=2 weeks prior to starting study drug. 10. Women of childbearing potential or non-sterilized men with partners of childbearing potential must use a medically acceptable contraceptive method (e.g., IUD, oral contraceptive, condom) from screening through 12 months after the last dose. 11. Voluntary informed consent signed; willing and able to comply with study procedures and follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior VEGFR TKI therapy within 6 months (including neoadjuvant or adjuvant settings). 2. Known hypersensitivity to recombinant humanized anti–PD-1 monoclonal antibodies or any of their components. 3. History of immunodeficiency, other acquired or congenital immunodeficiency disorders, or prior organ transplantation. 4. Pre-existing thyroid dysfunction that cannot be maintained within normal limits despite medical therapy. 5. Pregnant or lactating women. 6. Evidence of bleeding diathesis or clinically significant coagulopathy (in the absence of anticoagulant therapy). 7. Bleeding event from untreated or incompletely treated esophageal and/or gastric varices within 6 months before first study dose. 8. Major vascular disease within 6 months before first study dose (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis). 9. Inadequately controlled hypertension (systolic BP >=140 mmHg or diastolic BP >=90 mmHg on >=2 measurements averaged). Hypertensive crisis or hypertensive encephalopathy at any time. (Antihypertensive therapy is permitted to achieve target values.) 10. Serious cardiovascular disease within 3 months (NYHA Class II or higher heart failure, myocardial infarction, cerebrovascular accident), unstable arrhythmia, or unstable angina. 11. Severe, non-healing, or dehiscent wounds, active ulcers, or untreated fractures. 12. Hollow-needle biopsy or other minor surgery within 3 days before first study dose, excluding vascular-access device placement. 13. Major surgery within 4 weeks before first study dose, or anticipation of major surgery during the study. 14. Systemic immunosuppressive therapy within 2 weeks before first study dose (e.g., corticosteroids >10 mg/day prednisone or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti–TNF-a agents), or expected need for such therapy during study treatment. 15. Live-vaccine administration within 30 days before first study dose, planned vaccination during treatment, or expected need for live vaccine up to 5 months after the last study dose. 16. Known hypersensitivity to any study drug or excipient. 17. History of substance abuse that cannot be discontinued, or any psychiatric disorder that could compromise informed consent or study compliance. 18. Any condition judged by the investigator to render the participant unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;progression-free survival;time to response;duration of response;12-month progression-free survival rate;overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZhengyun Zou
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Outcome results
None listed