Recruiting PHASE2 Esophageal Squamous Cell Carcinoma (ESCC)

New treatment option for Esophageal Squamous Cell Carcinoma (ESCC)

Official title Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC

ClinicalTrials.gov ID: NCT06603402

What this study is testing

What it's testing
The aim of this clinical trial is to evaluate whether low-dose involved-field radiotherapy combined with immunochemotherapy can reduce treatment-related adverse effects, enhance progression-free survival (PFS), and improve overall survival (OS) in patients with locally advanced, unresectable esophageal squamous cell carcinoma. The key questions this study seeks to address are: Can low-dose involved-field radiotherapy combined with immunochemotherapy reduce treatment-related adverse effects?
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

  • Age 18-80 years
  • Patients with locally advanced, unresectable ESCC who have received radical treatment (radical chemoradiotherapy or radical radiochemotherapy)...
  • No evidence of tumor recurrence or metastasis on follow-up examination 2-3 weeks after radical treatment
  • Ability to provide fresh tumor tissue specimens (baseline)
  • Normal function of major organs

You likely can't join if

  • History of fistula formation due to primary tumor invasion
  • High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
  • Poor nutritional status
  • Previous immune-related adverse events during prior radical treatment, including grade ≥3 immune-related pneumonitis, myocarditis, etc
  • Presence of symptoms or signs of interstitial disease
  • Patients with any severe and/or uncontrolled medical condition
See the full eligibility criteria
Who can join
  • Age 18-80 years
  • Patients with locally advanced, unresectable ESCC who have received radical treatment (radical chemoradiotherapy or radical radiochemotherapy), including: Cervical esophagus involvement, T4 stage, supraclavicular lymph...
  • No evidence of tumor recurrence or metastasis on follow-up examination 2-3 weeks after radical treatment
  • Ability to provide fresh tumor tissue specimens (baseline)
  • Normal function of major organs
  • Performance Status (PS) score ≤ 1
  • Patients of childbearing potential must agree to use contraception.
  • Voluntary participation with signed informed consent
What rules you out
  • History of fistula formation due to primary tumor invasion
  • High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
  • Poor nutritional status
  • Previous immune-related adverse events during prior radical treatment, including grade ≥3 immune-related pneumonitis, myocarditis, etc
  • Presence of symptoms or signs of interstitial disease
  • Patients with any severe and/or uncontrolled medical condition
  • Presence of concurrent malignancies
  • Presence of other autoimmune diseases or long-term use of immunosuppressants or corticosteroids.
  • Patients who are difficult to communicate with or are unlikely to comply with long-term follow-up.
  • Any other conditions that the investigator deems unsuitable for participation.

The study team makes the final eligibility decision.

Where it's taking place

  • Chengdu, Sichuan, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.