Combining Toripalimab with Chemoradiotherapy for Esophageal Cancer

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

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.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Toripalimab
• Locations: 1 site (Guangzhou, Baiyun District)
• Trial ID: NCT06843889 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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

Eligibility 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 this trial is running

Guangzhou, Baiyun District

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

Study contacts

• Study coordinator: Wei Wang

Conditions Locally Advanced Esophageal Squamous Cell Carcinoma; Esophageal cancer; Immunotherapy; Neoadjuvant radiotherapy; Neoadjuvant chemotherapy; Efficacy