About this trial
This study is a prospective, multicenter, single arm, open label study aimed at evaluating the efficacy and safety of the combination of Carilizumab, Apatinib Mesylate, and first-line radiotherapy for advanced mucosal melanoma.
Eligibility criteria
Qualifiers
Age ≥ 18 years old, ≤ 80 years old, gender not limited
Confirmed by pathological histology, patients with recurrent, unresectable, or metastatic mucosal melanoma after surgery
In the late stage, no systemic anti-tumor drug treatment has been received, and previous radical surgical resection, adjuvant or neoadjuvant therapy is allowed. However, it is required to be completed at least 4 weeks before randomization, and all treatment-related toxicity events have returned to normal or CTCAE 5.0 grade I or below (except for hair loss, skin hypopigmentation, well controlled hypothyroidism, and adrenal insufficiency)
There must be at least one measurable lesion that has not undergone local treatment (according to RECIST v1.1 requirements, the length of the measurable lesion on spiral CT or MRI scan must be ≥ 10 mm or the length of enlarged lymph nodes must be ≥ 15 mm)
Disqualifiers
Patients who have received VEGFR TKI treatment within the past 6 months (including neoadjuvant and adjuvant treatment periods)
Individuals known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components
History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation
Previous thyroid dysfunction and inability to maintain normal thyroid function even with medication treatment
Trial design
Treatments tested in this trial
- Carilizumab and Apatinib