Combination of Carilizumab, Apatinib, and Radiotherapy for Advanced Mucosal Melanoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations