Neoadjuvant Treatment of Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant Docetaxel Combined With Cisplatin and 5-fluorouracil (DCF) in Esophageal Squamous Cell Carcinoma (TD-NEOE3V3)

January 29, 2026 updated by: Tang-Du Hospital

A Multicenter, Randomized Controlled Clinical Study Comparing Neoadjuvant Toripalimab Combined With Nab-paclitaxel and Platinum Versus Neoadjuvant Docetaxel Combined With Cisplatin and 5-fluorouracil (DCF) in the Treatment of Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

This study is a randomized, controlled, open-label, multicenter Phase III clinical trial, designed to evaluate the efficacy and safety of neoadjuvant toripalimab in combination with nab-paclitaxel and platinum versus neoadjuvant docetaxel in combination with cisplatin and 5-fluorouracil (DCF) in the treatment of resectable locally advanced esophageal squamous cell carcinoma

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

390

Phase

  • Phase 3

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 Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Tangdu Hospitial, Xi'an, Shaanxi Rrovince
        • Contact:
        • Principal Investigator:
          • Xiaolong Yan
        • Principal Investigator:
          • Jie Lei

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:

  • Patients who meet all of the following criteria are eligible to participate in the study:

    1. Voluntarily sign the written informed consent form;
    2. Age 18-75 years, inclusive of 18 and 75 years, both male and female;
    3. Life expectancy of ≥3 months;
    4. Expected to achieve R0 resection;
    5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
    6. Patients with resectable locally advanced (T1 N1-3 M0 or T2-4a N0-3 M0 (T2≥3cm or poorly differentiated)) thoracic esophageal squamous cell carcinoma confirmed by histology and who have not previously received treatment;
    7. No suspicious metastatic lymph nodes in the neck (excluding regional lymph nodes in the upper thoracic esophageal cancer area) as suggested by neck ultrasound or enhanced CT, and no systemic metastasis detected by imaging studies;
    8. Presence of a definite tumor lesion;

    9. Good organ function as indicated by screening laboratory test results:

      1. Hematology (no blood transfusions or treatment with blood products or granulocyte colony-stimulating factor within 14 days): Neutrophil count (NEU) ≥1.5×10⁹/L (1,500/mm³); Platelet (PLT) count ≥100×10⁹/L (100,000/mm³); Hemoglobin ≥90 g/L.
      2. Liver: Total bilirubin (TBil) ≤1.5×ULN; or for participants with total bilirubin levels <1.5×ULN, direct bilirubin within normal limits; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;
      3. Kidney: Serum creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (using the Cockcroft-Gault formula);
      4. Coagulation function: International normalized ratio (INR) ≤1.5, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5×ULN;
    10. Fertile males or females of childbearing potential must use effective contraception methods (such as oral contraceptives, intrauterine devices, or barrier methods combined with spermicides) during the trial and continue contraception for 6 months after the end of treatment;
    11. Good compliance and willingness to cooperate with follow-up visits.

Exclusion Criteria:

  • Patients who meet any of the following criteria are ineligible for this study:

    1. Previous treatment with PD-1/PD-L1 agents or drugs targeting another T-cell receptor (e.g., CTLA-4, OX-40, etc.);
    2. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
    3. Active autoimmune disease or suspicion of such, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc., with the exception of type 1 diabetes and hypothyroidism controlled with stable-dose replacement therapy, and skin diseases not requiring systemic treatment (e.g., psoriasis, vitiligo);
    4. History of interstitial lung disease ≥ Grade 2;
    5. Received systemic corticosteroids (prednisone >10mg/day or equivalent) or other immunosuppressive drugs within 14 days prior to the first study drug administration;
    6. History of immunodeficiency, including other acquired or congenital immunodeficiency diseases, history of organ transplantation, or having undergone allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
    7. Received live vaccine within 4 weeks prior to the first study drug administration;

    8. Presence of severe cardiovascular and cerebrovascular diseases:

      1. Uncontrolled hypertension or pulmonary arterial hypertension;
      2. Unstable angina or myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months prior to study drug administration;
      3. Chronic heart failure with cardiac function ≥ Grade 2 (New York Heart Association [NYHA] classification);
      4. Left ventricular ejection fraction (LVEF) <50%;
      5. Severe arrhythmias requiring drug treatment (excluding atrial fibrillation or paroxysmal supraventricular tachycardia). For example: male QTcF >450 msec or female QTcF >470 msec, complete left bundle branch block, third-degree atrioventricular block;
      6. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to study drug administration;
    9. Presence of uncontrollable or severe underlying diseases, including but not limited to active infections requiring systemic antibiotic therapy;

    10. Positive test results for human immunodeficiency virus (HIV) antibodies, active hepatitis B or C. The following cases are allowed to participate in this study:

      1. Positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), but HBV DNA below the detection limit of the study center (negative) or <500IU/ML, and after clinical treatment and presentation, the investigator determines that there is no active infection;
      2. Positive for hepatitis C antibody, but HCV RNA below the detection limit of the study center (negative);
    11. Known active tuberculosis (TB). Patients suspected of having active TB must be excluded by chest X-ray, sputum tests, and clinical symptoms and signs;
    12. Presence of other active malignancies within the past 2 years, excluding malignancies that are expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell carcinoma of the skin, or ductal carcinoma in situ of the breast treated with radical surgery);
    13. History of substance abuse or mental disorders that cannot be controlled;
    14. Pregnant or breastfeeding women;
    15. Presence of other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, in the investigator's judgment, may increase the risk associated with participation in the study or may interfere with the interpretation of study results.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3 cycles (Toripalimab + chemotherapy)
Participants receive totally 3 cycles of Toripalimab combined with nab-paclitaxel and cisplatin during neoadjuvant period
Drug: 3 cycles (Toripalimab + chemotherapy)
Toripalimab: 240mg, intravenous infusion, on Day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; Nab-paclitaxel: 125mg/m², intravenous infusion, on Day 1 and Day 8, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; Cisplatin: 75mg/m², intravenous infusion, on Day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment;
Active Comparator: 3 cycles（DCF）
Participants receive totally 3 cycles of Docetaxel combined with Cisplatin and 5-FU (5-fluorouracil) during neoadjuvant period
Drug: 3 cycles（DCF）
Docetaxel: 70mg/m², intravenous infusion, on day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; Cisplatin: 70mg/m², intravenous infusion, on day 1, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment; 5-FU (5-fluorouracil): 750mg/m², intravenous infusion, on day 1 to day 5, every 3 weeks (Q3W), for 3 cycles of neoadjuvant treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathological complete response rate (pCR)
Time Frame: Pathological detection after surgery within 1 month
Pathological detection after surgery within 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Major pathological response rate (MPR)
Time Frame: Pathological detection after surgery within 1 month
Pathological detection after surgery within 1 month
objective response rate (ORR)
Time Frame: From enrollment to the period before surgery (4-6 weeks after the third cycle of treatment).
From enrollment to the period before surgery (4-6 weeks after the third cycle of treatment).
event-free survival (EFS)
Time Frame: from randomization to disease progression that makes surgery impossible, postoperative disease progression, local or distant recurrence, or death from any cause (whichever occurs first，assessed up to 60 months)
from randomization to disease progression that makes surgery impossible, postoperative disease progression, local or distant recurrence, or death from any cause (whichever occurs first，assessed up to 60 months)
overall survival
Time Frame: from randomization to death from any cause，assessed up to 60 months
from randomization to death from any cause，assessed up to 60 months
Adverse events
Time Frame: form date of enrollment until the end of the study, assessed up to 60 months
form date of enrollment until the end of the study, assessed up to 60 months

Collaborators and Investigators

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

Sponsor

Tang-Du Hospital

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)

February 1, 2026

Primary Completion (Estimated)

December 28, 2027

Study Completion (Estimated)

December 28, 2028

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K202504-09

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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