Actively Recruiting
Paclitaxel Polymersomes + Carboplatin + Adebelimab: Neoadjuvant Phase Ⅱ Single-Arm Study for Resectable Mucosal Melanoma
Led by Sun Yat-sen University · Updated on 2026-01-13
32
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the pathological response rate of neoadjuvant therapy with paclitaxel polymersomes for injection combined with carboplatin and adebrelimab in patients with resectable mucosal melanoma.Subjects will receive the combination therapy of paclitaxel polymersomes for injection, carboplatin and adebrelimab prior to surgery, with a treatment cycle of 3 weeks and a total of 3 cycles.After completing 3 cycles of treatment, subjects will undergo curative surgery. Pathologists will evaluate the surgically resected specimens to determine the status of pathological response, and immunohistochemical assays will be performed to assess the intensity of immune activation within the tumor microenvironment.
CONDITIONS
Official Title
Paclitaxel Polymersomes + Carboplatin + Adebelimab: Neoadjuvant Phase Ⅱ Single-Arm Study for Resectable Mucosal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histopathologically confirmed resectable mucosal melanoma
- Ability to provide 5 formalin-fixed paraffin-embedded (FFPE) tissue sections before treatment or willingness to undergo needle biopsy for tissue collection
- ECOG Performance Status score of 0 or 1
- No prior treatment with immune checkpoint inhibitors such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies
- No prior treatment with taxane-based drugs
- Presence of measurable lesions according to RECIST 1.1 criteria
- No immunosuppressant use within 6 months before enrollment
- Hematological and biochemical tests meeting specified criteria for neutrophil count, platelet count, hemoglobin, serum creatinine, liver enzymes, and bilirubin
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception
You will not qualify if you...
- Presence of distant metastatic lesions
- Active autoimmune disease, except vitiligo, type 1 diabetes mellitus, or Hashimoto's thyroiditis with hypothyroidism requiring only hormone replacement therapy
- Need for systemic corticosteroid therapy above 10 mg prednisolone daily or other immunosuppressants within 14 days after enrollment
- Concurrent diagnosis of other malignant tumors requiring anti-tumor treatment unless in complete remission for 2 years or more without needing treatment during the study
- Medical, psychological, or physical inability to complete the study or understand study information
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other immune regulatory pathway drugs
- Prior chemotherapy with taxane-based drugs
- Positive HIV test or diagnosis of AIDS
- Known allergy to the study drugs
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
X
xizhiwen wen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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