Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

Combining Toripalimab with Chemoradiotherapy for Esophageal Cancer

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

Run by Nanfang Hospital, Southern Medical University · NCT06843889 · Data updated 2026-11-12

This study is testing if adding a new drug called Toripalimab to standard chemotherapy and radiation can help people with locally advanced esophageal cancer respond better to treatment before surgery.

More Locally Advanced Head and Neck Squamous Cell Carcinoma trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment34 (estimated)
SponsorNanfang Hospital, Southern Medical University
Academic / other
Drugs / interventionschemotherapy, immunotherapy, Toripalimab
Locations1 site (Guangzhou, Baiyun District)
StatusRecruiting
StartedApril 3, 2025
Main results expectedAugust 1, 2027
Study endsAugust 1, 2028
Registry record updatedApril 16, 2025
Trial IDNCT06843889 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-75 with resectable esophageal squamous cell carcinoma and no prior anti-tumor therapy.

Probably not a fit

Patients with severe organ diseases or those who have a history of esophageal perforation or active bleeding may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial investigates the efficacy of Toripalimab, an anti-PD-1 antibody, in combination with sequential neoadjuvant chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. A total of 34 patients will receive Toripalimab alongside a chemotherapy regimen, followed by radiotherapy before surgical intervention. The study aims to evaluate the pathological complete response and major response rates, as well as disease-free and overall survival outcomes. Adverse reactions will also be monitored throughout the treatment process.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with esophageal squamous cell carcinoma.

How similar studies have gone: Other studies have shown promising results with similar immunotherapy approaches in esophageal cancer, indicating potential for success in this trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.