Esophageal Squamous Cell Carcinoma (ESCC)Phase 3TD-NEOE3V3NCT06952621
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
A Phase 3 study testing 3 cycles (Toripalimab + chemotherapy) and 3 cycles（DCF） in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Tang-Du Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- 3 cycles (Toripalimab + chemotherapy) and 3 cycles（DCF）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 28 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- Good compliance and willingness to cooperate with follow-up visits.
Who cannot join
- 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;
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- 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;
- Presence of uncontrollable or severe underlying diseases, including but not limited to active infections requiring systemic antibiotic therapy;
- Positive test results for human immunodeficiency virus (HIV) antibodies, active hepatitis B or C. The following cases are allowed to participate in this study:
- 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;
- Positive for hepatitis C antibody, but HCV RNA below the detection limit of the study center (negative);
- Known active tuberculosis (TB). Patients suspected of having active TB must be excluded by chest X-ray, sputum tests, and clinical symptoms and signs;
- 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);
- History of substance abuse or mental disorders that cannot be controlled;
- Pregnant or breastfeeding women;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tangdu Hospitial, Xi'an, Shaanxi Rrovince
Xi'an, Shaanxi
Shicao Li, +86 02984777631, tangduec@126.com
Xiaolong Yan
About this study
Official title: 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
- Being tested
- 3 cycles (Toripalimab + chemotherapy), 3 cycles（DCF）
- Keywords
- toripalimab, DCF, neoadjuvant
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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（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
| Study group | Role | What they receive |
|---|---|---|
| 3 cycles (Toripalimab + chemotherapy) | Experimental | Participants receive totally 3 cycles of Toripalimab combined with nab-paclitaxel and cisplatin during neoadjuvant period Receives: 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 Receives: Drug: 3 cycles（DCF） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
Measured: Pathological detection after surgery within 1 month
Secondary outcomes (5)
Major pathological response rate (MPR)
Measured: Pathological detection after surgery within 1 month
objective response rate (ORR)
Measured: From enrollment to the period before surgery (4-6 weeks after the third cycle of treatment).
event-free survival (EFS)
Measured: 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
Measured: from randomization to death from any cause，assessed up to 60 months
Adverse events
Measured: form date of enrollment until the end of the study, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Feb 2026 (estimated)
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952621
- Sponsor's protocol ID
- K202504-09
- Acronym
- TD-NEOE3V3
- Status last verified
- Jan 2026
- First submitted
- 11 Apr 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06952621
- Acronym / sponsor ID
- TD-NEOE3V3 / K202504-09
- Keywords
- toripalimab, DCF, neoadjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Dec 2028 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 cycles (Toripalimab + chemotherapy) | Experimental | Drug: 3 cycles (Toripalimab + chemotherapy)Participants receive totally 3 cycles of Toripalimab combined with nab-paclitaxel and cisplatin during neoadjuvant period |
| 3 cycles（DCF） | Active comparator | Drug: 3 cycles（DCF）Participants receive totally 3 cycles of Docetaxel combined with Cisplatin and 5-FU (5-fluorouracil) during neoadjuvant period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients who meet all of the following criteria are eligible to participate in the study:
Key exclusion criteria (24 listed)
- Patients who meet any of the following criteria are ineligible for this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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; | Drug | 3 cycles (Toripalimab + chemotherapy) |
| 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 | Drug | 3 cycles（DCF） |
Primary outcome
Pathological complete response rate (pCR)
Time frame: Pathological detection after surgery within 1 month
5 secondary outcomes
Major pathological response rate (MPR)
Time frame: 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).
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)
overall survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3 cycles (Toripalimab + chemotherapy) and 3 cycles（DCF） in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Yan (+86 15991269383, yanxiaolong@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: Pathological detection after surgery within 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.