Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06190782

Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

Led by Fudan University · Updated on 2024-05-02

354

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone. The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.

CONDITIONS

Official Title

Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • ECOG performance status 0 or 1
  • Diagnosed with esophageal squamous cell carcinoma
  • Have genuine oligometastatic disease defined by ASTRO/ESTRO with 4 or fewer distant metastases
  • Have 3 or fewer metastatic lesions within a single organ
  • Each metastatic lesion measures 5 cm or less in diameter
  • At least one metastasis is confirmed by pathology
Not Eligible

You will not qualify if you...

  • History of widespread metastases or induced oligometastatic disease as defined by ASTRO/ESTRO
  • Esophageal perforation or hemorrhage
  • Disease progression after PD-1 inhibitor treatment
  • Recurrence of cancer within previously treated area
  • Unable to tolerate chemotherapy or immunotherapy
  • Lung radiation exposure (V20) greater than 25%

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai cancer center

Shanghai, China

Actively Recruiting

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Research Team

Q

Qi Liu, MD

CONTACT

K

Kuaile Zhao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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