Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05978193

Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma

Led by Shanghai Chest Hospital · Updated on 2026-01-22

100

Participants Needed

2

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy.

CONDITIONS

Official Title

Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed metastatic esophageal squamous cell carcinoma (stage IVB, M1) by pathology
  • ECOG performance status of 0 or 1
  • No prior anti-tumor treatment
  • Adequate blood, kidney, liver, and heart function suitable for chemotherapy and immunotherapy as evaluated by investigators
Not Eligible

You will not qualify if you...

  • Esophageal cancer that is not squamous cell carcinoma or mixed with other types
  • Patients considered potentially curable by surgery
  • Presence of pleural metastasis, malignant pleural effusion, or pericardial effusion
  • Any previous anti-tumor therapy for esophageal cancer including surgery, radiotherapy, chemotherapy, or immunotherapy
  • High risk of gastrointestinal bleeding, esophageal fistula, or perforation
  • Patient-Generated Subjective Global Assessment (PG-SGA) score of 9 or higher
  • Unstable heart disease or symptoms
  • History of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, or uncontrolled acute lung disease
  • Active or history of autoimmune disease
  • Immunodeficiency or active infection requiring systemic treatment
  • Pregnant or breastfeeding
  • Having a second primary cancer or cancer history within the past 5 years (except fully cured cervical carcinoma in situ or certain skin carcinomas)

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Shanghai Ruijin Hospital

Shanghai, China, 200020

Actively Recruiting

2

Shanghai Chest Hospital

Shanghai, China, 200030

Actively Recruiting

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Research Team

W

Wen Yu, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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