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Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

NCT07799077 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-09-02

No results posted yet for this study

Summary

Locally advanced Esophageal Squamous Cell Carcinoma (ESCC) has poor prognosis with standard therapies. Neoadjuvant immunochemotherapy improves pathological response rates, but optimal regimens remain undefined. Paclitaxel polymeric micelles offer enhanced tumor targeting (EPR effect) and reduced toxicity vs. conventional paclitaxel formulations, with no need for premedication. This single-arm, prospective trial evaluates the efficacy and safety of neoadjuvant sintilimab combined with paclitaxel polymeric micelles and cisplatin in resectable locally advanced ESCC.

Conditions

Interventions

DRUG

Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab

1. Sindilimab : 200 mg, Q3W, intravenous infusion, D1 ; 2. Paclitaxel polymeric micelles : 300 mg/m2 ; q3W, intravenous infusion, D1 ; 3. Cisplatin : 75 mg/m2 ; q3W ; intravenous infusion, D1 ;

Sponsors & Collaborators

  • Shanghai Yizhong Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Hebei Medical University Fourth Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-31
Completion
2029-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07799077 on ClinicalTrials.gov