Clinical trial · Interventional
NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC
Neoadjuvant Chemoradiotherapy Combined With Sequential Perioperative PD-1 Inhibitor for Locally Advanced Esophageal Squamous Cell Carcinoma
NCT06762158CI-TRIAL-00084421active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to examine the efficacy of the combination of neoadjuvant chemoradiotherapy and perioperative PD-1 inhibitor in patients with locally advanced esophageal squamous cell cancer and explore the predictive biomarkers for this regimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant immunotherapy | Drug | — | UNRESOLVED |
| Neoadjuvant Chemoradiotherapy | Radiation | — | UNRESOLVED |
| neoadjuvant immunotherapy | Drug | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perioperative toripalimab
- description
- neoadjuvant chemoradiotherapy and perioperative toripalimab
- interventionNames
- Radiation: Neoadjuvant Chemoradiotherapy
- Drug: neoadjuvant immunotherapy
- Procedure: Surgery
- Drug: adjuvant immunotherapy
Primary outcomes (1)
- measure
- pathologically complete response(pCR)
- timeFrame
- From date of surgery to 4 weeks later
- description
- absence of viable tumor cells in the resected cancer specimen（ypT0N0）
Secondary outcomes (1)
- measure
- event free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18-75 years old * Histologically or cytologically confirmed esophageal squamous cell cancer * Stage T3-4aN0M0 or TanyN1-3M0 according to the American Joint Committee on Cancer staging manual eighth edition * Eastern Cooperative Oncology Group performance status of 0 or 1 * he indexes of hematology, biochemistry and organ function meet the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L；b. neutrophil count (ANC) ≥ 1.5×109/L; c. platelets ≥ 85×109/L; d. hemoglobin ≥ 90g/L; e. total bilirubin ≤ 1.5 ULN; f. ALT ≤ 1.5 ULN; g. creatinine clearance rate \>60 mL/min; * The cardiopulmonary function needs to meet the following criteria: EF ≥ 55%, VC \> 60%, FEV1 \> 1.2L, FEV1%\> 40%, DLco \> 40% * Women of childbearing age must undergo a pregnancy test within 7 days before enrollment for treatment, and only those with a negative result can be enrolled * Voluntarily participating in this study Exclusion Criteria: * Patients with active infection within 2 weeks before the first use of the study drug * A history of interstitial lung disease or non-infectious pneumonia * A history of autoimmune diseases or abnormal immune system * Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction * Patients diagnosed with any other malignant tumor within 5 years before enrollment, except for malignant tumors with low risk of recurrence and risk of death, such as fully treated basal cell or squamous cell skin and carcinoma in situ of the cervix; * Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs nab-paclitaxel or cisplatin * A history of immunodeficiency，including a positive HIV test result or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation * Women during pregnancy or lactation * Other situations not suitable for enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.