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

NCT07799077 | Not Yet Recruiting Phase 2

• 1 other identifier: ZSGJSIITRX003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal squamous cell carcinoma; Locally advanced resectable; Paclitaxel Polymeric Micelles

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) rate

  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 Outcomes (6)

• Major Pathological Response (MPR) rate

  Perioperative

• R0 resection rate

  Perioperative

• Objective Response Rate (ORR) per RECIST v1.1

  Assessed at baseline and pre-surgery

• Event-Free Survival (EFS)

  Follow-up every 3 months for 2 years, then every 6 months up to 5 years

• Overall Survival (OS)

  Follow-up every 3 months for 2 years, then every 6 months up to 5 years

Study Arms (1)

Paclitaxel polymer micelles and cisplatin combined with sintilimab

EXPERIMENTAL

Drug: Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab

Interventions

Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab DRUG

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 ;

Paclitaxel polymer micelles and cisplatin combined with sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent was signed before the implementation of any test-related procedures ;
• Age 18-75 years ;
• Esophageal squamous cell carcinoma confirmed by histopathology ;
• Resectable thoracic cT1b-2N1-3M0 or cT2-3N0M0 ;
• No anti-tumor treatment has been received ;
• ECOG PS 0-1 ;
• Expected survival ≥ 3 months ;
• At least one measurable lesion per RECIST v1.1;
• Adequate organ function (hematology, liver, kidney, coagulation, thyroid, myocardial enzymes) ;
• 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 ;
• 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 ).

You may not qualify if:

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

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead
• Shanghai Yizhong Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Hebei, Shijiazhuang, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Injections; sintilimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Ziqiang Tian

CONTACT

+8618538881000; tizq12@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 2, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)