Clinical trial · Observational
A Prospective Study of Tumor-specific Tpex in Negative Lymph Nodes for Predicting Pathological Complete Response to Neoadjuvant PD 1 Therapy in Esophageal Cancer
NCT07573397CI-TRIAL-00110765not yet recruitingClinicalTrials.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)
The goal of this observational study is to to determine whether patients with a high proportion of precursor exhausted T cells (Tpex) in negative tumor draining lymph nodes have higher pCR. The main question it aims to answer is: Whether precursor exhausted T cells (Tpex) in negative tumor-draining lymph nodes have better predictive efficacy for treatment response than PD-L1 CPS.
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- PD-1 treatment group
Primary outcomes (1)
- measure
- pCR rate
- timeFrame
- From enrollment to the surgery
- description
- pathologic complete response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed esophageal squamous cell carcinoma * patients eligible for surgery * plan to treated with neoadjuvant PD-1 immunotherapy * Eastern Cooperative Oncology Group(ECOG) performance status: 0-2 Exclusion Criteria: * Esophageal perforation or hematemesis * Any active autoimmune disease or a history of autoimmune disease * Disease progression occurs within 3months after PD-1 immunotherapy. * Allergic to macromolecular protein preparations, or to any of the ingredients in PD-1 inhibitors for injection. * Uncontrolled heart diseases or clinical symptoms * Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
References
Publications (0)
Data not yet available
No reference posted for this study.