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

NCT06952621 | Not Yet Recruiting Phase 3

• 1 other identifier: K202504-09
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Keywords

toripalimab; DCF; neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  Pathological detection after surgery within 1 month

Secondary Outcomes (5)

• Major pathological response rate (MPR)

  Pathological detection after surgery within 1 month

• objective response rate (ORR)

  From enrollment to the period before surgery (4-6 weeks after the third cycle of treatment).

• event-free survival (EFS)

  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

  from randomization to death from any cause，assessed up to 60 months

• Adverse events

  form date of enrollment until the end of the study, assessed up to 60 months

Study Arms (2)

3 cycles (Toripalimab + chemotherapy)

EXPERIMENTAL

Participants receive totally 3 cycles of Toripalimab combined with nab-paclitaxel and cisplatin during neoadjuvant period

Drug: 3 cycles (Toripalimab + chemotherapy)

3 cycles（DCF）

ACTIVE COMPARATOR

Participants receive totally 3 cycles of Docetaxel combined with Cisplatin and 5-FU (5-fluorouracil) during neoadjuvant period

Drug: 3 cycles（DCF）

Interventions

3 cycles (Toripalimab + chemotherapy) DRUG

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;

3 cycles (Toripalimab + chemotherapy)

3 cycles（DCF） DRUG

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

3 cycles（DCF）

Eligibility Criteria

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

You may qualify if:

• Patients who meet all of the following criteria are eligible to participate in the study:
• Voluntarily sign the written informed consent form;
• Age 18-75 years, inclusive of 18 and 75 years, both male and female;
• Life expectancy of ≥3 months;
• Expected to achieve R0 resection;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• 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;
• 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;
• Presence of a definite tumor lesion;
• Good organ function as indicated by screening laboratory test results:
• 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.
• 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;
• Kidney: Serum creatinine ≤1.5×ULN or calculated creatinine clearance (CrCl) ≥60 mL/min (using the Cockcroft-Gault formula);
• Coagulation function: International normalized ratio (INR) ≤1.5, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤1.5×ULN;
• 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;

You may not qualify if:

• Patients who meet any of the following criteria are ineligible for this study:
• Previous treatment with PD-1/PD-L1 agents or drugs targeting another T-cell receptor (e.g., CTLA-4, OX-40, etc.);
• Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
• 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);
• History of interstitial lung disease ≥ Grade 2;
• Received systemic corticosteroids (prednisone \>10mg/day or equivalent) or other immunosuppressive drugs within 14 days prior to the first study drug administration;
• 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;
• Received live vaccine within 4 weeks prior to the first study drug administration;
• Presence of severe cardiovascular and cerebrovascular diseases:
• Uncontrolled hypertension or pulmonary arterial hypertension;
• Unstable angina or myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months prior to study drug administration;
• Chronic heart failure with cardiac function ≥ Grade 2 (New York Heart Association \[NYHA\] classification);
• Left ventricular ejection fraction (LVEF) \<50%;
• 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;
• Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to study drug administration;

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospitial, Xi'an, Shaanxi Rrovince

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

toripalimab; Drug Therapy

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)

Therapeutics

Central Study Contacts

Xiaolong Yan

CONTACT

+86 15991269383; yanxiaolong@fmmu.edu.cn

Jie Lei

CONTACT

+86 17788030168; leijiemd@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: May 1, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): December 28, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)