Not Yet RecruitingPhase 2

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

30 participantsStarted 2025-11-30

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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)
✓. At least one lesion that can receive radiotherapy
✓. ECOG PS 0 or 1 point
✓. Expected survival period ≥ 12 weeks
✓. No contraindications for treatment, with sufficient organ and bone marrow function: ① Absolute neutrophil count ≥ 1.5 × 109/L ② Platelets ≥ 80 × 109/L③ Hemoglobin ≥ 90 g/L④ ALT and AST ≤ 1.5 × ULN⑤ Bilirubin ≤ 1.5 × ULN⑥ Blood creatinine ≤ 1.5 × ULN

Exclusion criteria

✕. 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
✕. Pregnant or lactating women
✕. Evidence of bleeding quality or significant coagulation dysfunction (not receiving anticoagulant therapy)
✕. Bleeding events occurring within 6 months prior to the first medication due to untreated or incompletely treated esophageal and/or gastric varices
✕. Major vascular disease (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occurred within 6 months before the first use of medication

What they're measuring

6-month progression free survival rate

Timeframe: From the day each patient starts treatment until the 6th month (180 days).

Trial details

NCT IDNCT07236528

SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Zou Zhengyun

+8613815891858 zouzhengyun@medmail.com.cn

View on ClinicalTrials.gov More Mucosal Melanoma trials