NCT07573397

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
28mo left

Started May 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2028

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Esophageal Cancer

Keywords

esophageal squamous cell carcinomaPD 1 inhibitorsnegative tumor draining lymph nodesTpexpCR

Outcome Measures

Primary Outcomes (1)

  • pCR rate

    pathologic complete response rate

    From enrollment to the surgery

Study Arms (1)

PD-1 treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with locally advanced esophageal squamous cell carcinoma

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start

May 6, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 20, 2028

Last Updated

May 7, 2026

Record last verified: 2026-05