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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma (NCT06843889) is a Phase 2 interventional studying Locally Advanced Esophageal Squamous Cell Carcinoma, sponsored by Nanfang Hospital, Southern Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This was a single-center, open phase II clinical study. 34 patients with resectable local middle and advanced esophageal squamous cell carcinoma were treated with anti-PD-1 antibody combined with sequential chemoratherapy regimen: Phase I:Toripalimab (240mg day1, Q3W\*2cycle) + clinical routine chemotherapy regimen selected by the investigator; The second stage: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion. According to the postoperative pathological results, the pathological complete response (pCR) and major response (MPR) were evaluated. The disease-free survival (DFS), overall survival (OS), 1 or 2 years survival rate and adverse reactions were recorded.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Locally Advanced Esophageal Squamous Cell Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 34 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 1: age 18-75 years old, both sexes; 2: esophageal squamous cell carcinoma confirmed by histopathology; 3: T2-4a, N0-3, M0 (AJCC 8th edition) thoracic esophageal cancer patients, resectable by surgical evaluation; 4: initial treatment patients without anti-tumor therapy; 5: expected survival time ≥6 months; 6: ECOG ≤1; 7: There was no history of esophageal perforation, active esophageal bleeding, and no obvious invasion of trachea or thoracic large vessels. 8: The function of vital organs meets the following requirements: white blood cell ≥4.0×109/l, neutrophil ≥1.5×109/l, platelet count at least 100.0×109/l, blood count (hemoglobin) at least 90g/l; Serum albumin ≥2.8g/Dl; Total bilirubin ≤1.5 × ULN, ALT/AST/ AKP≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance \> 60 mL/min; There were no severe organic diseases. 9: FEV1 ≥ 0.8L; 10: Patients were informed about the trial details and signed willing to sign a consent form. Who Should NOT Join This Trial: - 1: known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components; 2: currently participating in and receiving other study treatment; 3: previous systemic therapy for esophageal cancer, including systemic chemotherapy, targeted therapy, immunotherapy, etc. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 1: age 18-75 years old, both sexes; 2: esophageal squamous cell carcinoma confirmed by histopathology; 3: T2-4a, N0-3, M0 (AJCC 8th edition) thoracic esophageal cancer patients, resectable by surgical evaluation; 4: initial treatment patients without anti-tumor therapy; 5: expected survival time ≥6 months; 6: ECOG ≤1; 7: There was no history of esophageal perforation, active esophageal bleeding, and no obvious invasion of trachea or thoracic large vessels. 8: The function of vital organs meets the following requirements: white blood cell ≥4.0×109/l, neutrophil ≥1.5×109/l, platelet ≥100.0×109/l, hemoglobin ≥90g/l; Serum albumin ≥2.8g/Dl; Total bilirubin ≤1.5 × ULN, ALT/AST/ AKP≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance \> 60 mL/min; There were no severe organic diseases. 9: FEV1 ≥ 0.8L; 10: Patients were informed about the trial details and signed informed consent. Exclusion Criteria: * 1: known to be allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components; 2: currently participating in and receiving other study treatment; 3: previous systemic therapy for esophageal cancer, including systemic chemotherapy, targeted therapy, immunotherapy, etc. 4: patients with active pulmonary tuberculosis (TB) who were receiving anti-TB treatment or received anti-TB treatment within 1 year before screening; 5: uncontrolled or symptomatic hypercalcemia (\>1.5mmol/L calcium ion or calcium \>12mg/dL or corrected serum calcium \>ULN); 6: clinically uncontrolled active infection, including but not limited to acute pneumonia; 7: uncontrolled major seizures or superior vena cava syndrome; 8: previous or current concomitant other malignant tumors (except non-melanoma basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast/cervix, superficial bladder, etc., which were treated radically and had no evidence of disease recurrence) 9: Patients with a history of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, evidence of active pneumonia detected by chest CT scan or other moderate to severe lung diseases that seriously affect lung function; 10: known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 11: severe cardiovascular disease, such as New York Heart Association (NYHA) class 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 6 months before enrollment; 12: received systemic immunosuppressive drugs (i.e., corticosteroids or immunosuppressive drugs) for any active autoimmune disease within 2 years before study entry; 13: received live viral vaccine within 4 weeks before study entry; 14: patients with prior allogeneic stem cell or solid organ transplantation; 15: pregnant or lactating women or women with the possibility of pregnancy before the first medication positive pregnancy test, patients with fertility but unwilling to accept contraceptive measures or their sexual partners unwilling to accept contraceptive measures; 16: any other disease or condition of clinical significance that the investigator believes could affect adherence to the protocol (e.g., history of psychosis or substance abuse), preclude benefit from the study, or prevent informed consent (e.g., drug use and substance abuse), or preclude participation in the study (including but not limited to: Abnormal laboratory results, clinical active diverticulitis, intra-abdominal abscess, intestinal obstruction, and peritoneal carcinomatosis).

Treatments Being Tested

DRUG

Toripalimab (240mg day1, Q3W*3cycle)

Phase 1: Toripalimab (240mg day1, Q3W\*2cycle) + investigator's choice of clinical conventional chemotherapy; Phase 2: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Nanfang Hospital, Southern Medical University
Guangzhou, Baiyun District, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06843889), the sponsor (Nanfang Hospital, Southern Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06843889 clinical trial studying?

This was a single-center, open phase II clinical study. 34 patients with resectable local middle and advanced esophageal squamous cell carcinoma were treated with anti-PD-1 antibody combined with sequential chemoratherapy regimen: Phase I:Toripalimab (240mg day1, Q3W\*2cycle) + clinical routine chemotherapy regimen selected by the investigator; The second stage: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06843889?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06843889?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06843889. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06843889. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.