Paclitaxel Polymersomes + Carboplatin + Adebelimab: Neoadjuvant Phase Ⅱ Single-Arm Study for Resectable Mucosal Melanoma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Resectable Mucosal Melanoma
• Intervention / Treatment: Drug: Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab; Procedure: Radical Surgery

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: xizhiwen wen; Phone Number: +8602087343381; Email: wenxz@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: xizhiwen wen; Phone Number: +8602087343381; Email: wenxz@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years old.
2. Histopathologically confirmed resectable mucosal melanoma.
3. 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.
4. ECOG (Performance Status, PS) score of 0-1.
5. No prior treatment with immune checkpoint inhibitors such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 monoclonal antibodies.
6. No prior treatment with taxane-based drugs.
7. Presence of measurable lesions (per RECIST 1.1 criteria).
8. No history of immunosuppressant use within 6 months prior to enrollment.

9. 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.

10. Women of childbearing potential must have a negative serum or urine pregnancy test and agree to use an appropriate contraceptive method (barrier contraception or oral contraceptives).

Exclusion Criteria:

1. Presence of distant metastatic lesions.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Prior chemotherapy with taxane-based drugs.
8. Positive HIV test result or confirmed diagnosis of acquired immunodeficiency syndrome (AIDS).
9. Known hypersensitivity to the study drugs.
10. Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab

Drug: Paclitaxel Polymersomes Combined with Carboplatin and Adebelimab; Chemotherapeutic agents are administered on Day 1 of each cycle: paclitaxel polymersomes for injection is given first, followed by carboplatin.Adebelimab injection is administered on Day 2 of each cycle.Patients will receive a maximum of 3 cycles of neoadjuvant chemotherapy combined with immunotherapy before surgery.Patients who are evaluated as resectable 3 weeks after the last cycle of chemotherapy will undergo radical surgery.; Procedure: Radical Surgery; Chemotherapeutic agents are administered on Day 1 of each cycle: paclitaxel polymersomes for injection is given first, followed by carboplatin.Adebelimab injection is administered on Day 2 of each cycle.Patients will receive a maximum of 3 cycles of neoadjuvant chemotherapy combined with immunotherapy before surgery.Patients who are evaluated as resectable 3 weeks after the last cycle of chemotherapy will undergo radical surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic response rate	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).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate	The proportion of patients who achieve complete response (CR) or partial response (PR) evaluated according to the RECIST 1.1 criteria based on imaging examinations.	8 weeks
Surgical Resection Rate	calculated as the number of patients who underwent scheduled surgical resection divided by the number of enrolled patients.	8 weeks
Acute and Chronic Toxicities and Adverse Reactions		8 weeks
relapse-free survival		8 weeks
Assessment of Immune Activation Intensity in the Tumor Microenvironment	defined as the magnitude of changes in the proportions of CXCL13, CD4, CD8, CD19, and FOXP3-positive cells and the structural alterations of tertiary lymphoid organs (TLOs) in the tumor microenvironment before and after treatment.	8 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): March 20, 2027
• Study Completion (Estimated): March 20, 2027

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Coordination Complexes; Carboplatin
• Other Study ID Numbers: B2024-799-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No