Condition: Melanoma (Skin Cancer) · Sponsor: Xijing Hospital
1. Primary Objective To evaluate the efficacy and safety of cadonilimab in combination with high-dose recombinant human interferon α1b injection as neoadjuvant therapy in patients with stage III/IV melanoma. Assessments include: Target lesion response (complete response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\]) Objective response rate (ORR) Pathological response rate (pathological complete response \[pCR\], near pCR, pathological partial response \[pPR\], pathological non-response \[pNR\]) Incidence of all adverse events (AEs) and serious adverse events (SAEs) Changes from baseline in physical examinations, vital signs, and laboratory test results. 2. Exploratory Objectives To investigate the correlation between treatment efficacy/patient outcomes and:PD-L1 expression in tumor tissue CD8+ T-cell infiltration Tumor mutational burden (TMB). 3. Study Significance To conduct a preliminary exploration in support of future multicenter clinical studies.
This description comes directly from the study's public registry record.
Weinan Guo · + 86-29-84775406 · guown@fmmu.edu.cn
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| Xijing Hospital, Air Force Medical University Xi'an, Shaanxi, China | Xi'an, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07586904