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NOT YET RECRUITING
NCT07740993
PHASE2

A Single-Arm Study of Sintilimab and Disitamab Vedotin for Locally Advanced Eyelid Sebaceous Gland Carcinoma

Sponsor: West China Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant therapy with Sintilimab combined with Disitamab Vedotin in patients with locally advanced, resectable or potentially resectable sebaceous gland carcinoma. The main questions it aims to answer are: What is the major pathological response (MPR) rate after the neoadjuvant therapy? What are the pathological complete response (pCR) rate, clinical objective response rate (ORR), disease control rate (DCR), safety profiles, and 1-year disease-free survival (DFS) of this regimen? Participants will:Receive neoadjuvant therapy consisting of Sintilimab (200 mg, IV, Day 1) and Disitamab Vedotin (2.5 mg/kg, IV, Day 1) every 3 weeks for a total of 2 cycles. Undergo radical surgery after the completion of the neoadjuvant treatment phase. Receive postoperative adjuvant therapy after surgery, which includes uniform Sintilimab monotherapy maintenance (200 mg, IV, Q3W) for up to 1 year, and may receive risk-stratified local interventions (such as local radiotherapy or repeat wide excision) depending on the pathological risk factors.

Official title: A Single-Arm, Prospective Clinical Study of Sintilimab Combined With Disitamab Vedotin as Neoadjuvant Therapy for Locally Advanced Eyelid Sebaceous Gland Carcinoma

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-08-01

Completion Date

2028-06-01

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

DRUG

Sintilimab

Sintilimab is administered at 200 mg intravenously on Day 1 of each 3-week cycle. In the neoadjuvant phase, it is given concurrently with Disitamab Vedotin for 2 cycles before radical surgery. In the adjuvant phase, post-surgery, it is administered as monotherapy maintenance for up to 1 year, or until intolerable toxicity or distant disease progression occurs.

DRUG

disitamab vedotin

Disitamab Vedotin is administered at 2.5 mg/kg intravenously on Day 1 of each 3-week cycle. It is given exclusively during the neoadjuvant phase for a total of 2 cycles concurrently with Sintilimab prior to radical surgery.

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China