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

NCT07740993 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Sebaceous Gland Carcinoma

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Principal Investigators

  • Xingchen Peng Peng, PhD · West China Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-10-01
Completion
2028-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07740993 on ClinicalTrials.gov