NCT07336979 Paclitaxel Polymersomes + Carboplatin + Adebelimab: Neoadjuvant Phase Ⅱ Single-Arm Study for Resectable Mucosal Melanoma
| NCT ID | NCT07336979 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Resectable Mucosal Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2027-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2025-03-20 with a primary completion date of 2027-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07336979 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Resectable Mucosal Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07336979 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07336979 currently recruiting?
Yes, NCT07336979 is actively recruiting participants. Contact the research team at wenxz@sysucc.org.cn for enrollment information.
Where is the NCT07336979 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07336979 clinical trial?
NCT07336979 is sponsored by Sun Yat-sen University. The trial plans to enroll 32 participants.
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