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

August 31, 2026 updated by: Hebei Medical University Fourth Hospital

Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-arm, Multicenter, Prospective Phase II Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shijiazhuang
      • Hebei, Shijiazhuang, China
        • The Fourth Hospital of Hebei Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Written informed consent was signed before the implementation of any test-related procedures ;
  2. Age 18-75 years ;
  3. Esophageal squamous cell carcinoma confirmed by histopathology ;
  4. Resectable thoracic cT1b-2N1-3M0 or cT2-3N0M0 ;
  5. No anti-tumor treatment has been received ;
  6. ECOG PS 0-1 ;
  7. Expected survival ≥ 3 months ;
  8. At least one measurable lesion per RECIST v1.1;
  9. Adequate organ function (hematology, liver, kidney, coagulation, thyroid, myocardial enzymes) ;
  10. For women of childbearing age, a negative urine or serum pregnancy test should be performed within three days prior to the first study drug administration ( day 1 of the first cycle ). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is required. Women of non-fertility age were defined as at least 1 year after menopause, or had undergone surgical sterilization or hysterectomy ;
  11. If there is a risk of conception, all subjects ( male or female ) are required to use contraception with an annual failure rate of less than 1 % throughout the treatment period up to 120 days after the last study drug administration ( or 180 days after the last study drug administration ).

Exclusion Criteria:

  1. High risk of tracheoesophageal fistula or aortoesophageal fistula
  2. Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy
  3. Participation in another interventional clinical trial within 4 weeks before the first dose
  4. History of other active malignancies (except cured low-risk tumors, adequately treated non-melanoma skin cancer, or carcinoma in situ)
  5. Active uncontrolled hepatitis B/C infection
  6. Uncontrolled systemic diseases (e.g., heart failure NYHA ≥II, interstitial lung disease, active autoimmune diseases requiring systemic immunosuppression)
  7. Allergy to study drugs or excipients
  8. Uncontrolled third-space effusion (e.g., pleural/pericardial effusion)
  9. Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel polymer micelles and cisplatin combined with sintilimab
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 ;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) rate
Time Frame: Assessed via surgical pathology (4-6 weeks post-neoadjuvant therapy)
Pathological Complete Response (pCR) rate: Proportion of patients with no residual invasive tumor in primary tumor bed and sampled lymph nodes (ypT0/Tis ypN0) after neoadjuvant therapy
Assessed via surgical pathology (4-6 weeks post-neoadjuvant therapy)

Secondary Outcome Measures

Outcome Measure
Time Frame
R0 resection rate
Time Frame: Perioperative
Perioperative
Major Pathological Response (MPR) rate
Time Frame: Perioperative
Perioperative
Objective Response Rate (ORR) per RECIST v1.1
Time Frame: Assessed at baseline and pre-surgery
Assessed at baseline and pre-surgery
Event-Free Survival (EFS)
Time Frame: Follow-up every 3 months for 2 years, then every 6 months up to 5 years
Follow-up every 3 months for 2 years, then every 6 months up to 5 years
Overall Survival (OS)
Time Frame: Follow-up every 3 months for 2 years, then every 6 months up to 5 years
Follow-up every 3 months for 2 years, then every 6 months up to 5 years
Safety: Incidence of adverse events (AEs), serious AEs (SAEs), and immune-related AEs (irAEs)
Time Frame: From initiation of treatment to 30 days post-last dose (or 90 days for SAEs)
From initiation of treatment to 30 days post-last dose (or 90 days for SAEs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Fourth Hospital

Collaborators

Shanghai Yizhong Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

July 30, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 2, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSGJSIITRX003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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