RecruitingPhase 2NCT07336979

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


Sponsor

Sun Yat-sen University

Enrollment

32 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — paclitaxel polymersomes (a new formulation of a chemotherapy drug), carboplatin, and adebelimab (an immunotherapy drug) — given before surgery (neoadjuvant treatment) in patients with resectable mucosal melanoma (a rare type of melanoma that occurs inside body cavities like the mouth, nose, or digestive tract). **You may be eligible if...** - You are 18 or older - You have confirmed resectable mucosal melanoma - You have not previously received immunotherapy (e.g., anti-PD-1 or anti-CTLA-4 drugs) or taxane-based chemotherapy - Your overall health is good (ECOG 0–1) and your blood counts and organ function meet the required thresholds **You may NOT be eligible if...** - You have received prior checkpoint immunotherapy or taxane chemotherapy - You have had immunosuppressant medications in the past 6 months - Your blood counts or organ function do not meet study requirements - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel 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.

PROCEDURERadical 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.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07336979