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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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.
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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGPathologic 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).
Time frame: 8 weeks
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.
Time frame: 8 weeks
Surgical Resection Rate
calculated as the number of patients who underwent scheduled surgical resection divided by the number of enrolled patients.
Time frame: 8 weeks
Acute and Chronic Toxicities and Adverse Reactions
Time frame: 8 weeks
relapse-free survival
Time frame: 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.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.