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RECRUITING
NCT07336979
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-03-20

Completion Date

2027-03-20

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

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.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China