A Single-Arm, Phase Ⅱ Exploratory Study of Neoadjuvant Therapy With Paclitaxel Polymersomes for Injection Combined With Carboplatin and Adebelimab in the Treatment of Resectable Mucosal Melanoma
概览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Sun Yat-sen University
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pathologic response rate
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Histopathologically confirmed resectable mucosal melanoma.
- •Subjects must provide 5 formalin-fixed paraffin-embedded (FFPE) tissue sections collected before treatment, or be willing to undergo needle biopsy for pathological tissue acquisition to facilitate pathological assessment.
- •ECOG (Performance Status, PS) score of 0-
- •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 (per RECIST 1.1 criteria).
- •No history of immunosuppressant use within 6 months prior to enrollment.
- •Hematological and biochemical test results meeting the following criteria:
- •i. Neutrophil count ≥ 1,500 × 10⁹/L; ii. Platelet count ≥ 100 × 10⁹/L; iii. Hemoglobin \> 9.0 g/dL; iv. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min; v. Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 3 × ULN; vi. Total bilirubin ≤ 1.5 × ULN.
排除标准
- •Presence of distant metastatic lesions.
- •Active autoimmune disease. Note: Patients with vitiligo, type 1 diabetes mellitus, or Hashimoto's thyroiditis with hypothyroidism who only require hormone replacement therapy may be enrolled if there is no evidence of significant disease recurrence.
- •Need for systemic corticosteroid therapy (\> 10 mg prednisolone \[or equivalent\]/daily) or other immunosuppressant use within 14 days after enrollment. Note: Inhaled or topical corticosteroids, or adrenal hormone replacement therapy (\> 10 mg prednisolone \[or equivalent\]/daily) are acceptable for patients without obvious autoimmune diseases.
- •Concurrent diagnosis of other malignant tumors requiring anti-tumor treatment. Note: Patients may be considered for enrollment if the other malignant tumor has achieved complete remission for 2 years or more and no additional anti-tumor treatment is required during the study period.
- •Patients who are medically, psychologically, or physically unable to complete the study or understand the information provided in the patient brochure, as assessed by the investigator.
- •Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other drugs targeting T-cell costimulatory or immune regulatory pathways.
- •Prior chemotherapy with taxane-based drugs.
- •Positive HIV test result or confirmed diagnosis of acquired immunodeficiency syndrome (AIDS).
- •Known hypersensitivity to the study drugs.
- •Pregnant or lactating women.
研究组 & 干预措施
Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab
干预措施: Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab (Drug)
Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab
干预措施: Radical Surgery (Procedure)
结局指标
主要结局
Pathologic response rate
时间窗: 8 weeks
The proportion of patients with less than 50% residual tumor cells in the surgically resected pathological specimens, including those who achieved pathological complete response (pCR), major pathological response (MPCR) and partial pathological response (pPR).
次要结局
- Surgical Resection Rate(8 weeks)
- Acute and Chronic Toxicities and Adverse Reactions(8 weeks)
- overall response rate(8 weeks)
- relapse-free survival(8 weeks)
- Assessment of Immune Activation Intensity in the Tumor Microenvironment(8 weeks)
研究者
xizhi wen
Principal Investigator
Sun Yat-sen University