Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06498752

MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-08-06

102

Participants Needed

1

Research Sites

45 weeks

Total Duration

On this page

Sponsors

C

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead Sponsor

P

Peking University Cancer Hospital & Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

To further validate the performance of the high-sensitivity MRD assay in patients with squamous esophageal cancer who have completed radical radiotherapy; to validate whether MRD-negative patients can maintain a good prognosis under regular follow-up; and to validate whether MRD-positive patients can improve their survival with consolidation therapy with PD-1 monotherapy.

CONDITIONS

Official Title

MRD-Guided Consolidation Therapy Following Definitive Radiotherapy in Esophageal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer, clinical stage I-VIa, primary unresectable
  • ECOG performance status 0 or 1
  • Normal routine blood tests and liver/kidney function
  • Completed radical radiotherapy with 50-60 Gy dose
  • Received systemic platinum-based chemotherapy combined with paclitaxel or 5-FU, with or without PD-1 monotherapy, or S-1 monotherapy for elderly patients
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • History of cancers other than hypopharyngeal carcinoma in situ, non-malignant skin cancer, or cervical carcinoma in situ
  • Current active infections or serious illnesses like myocardial infarction within 6 months
  • History of autoimmune diseases
  • Participation in other clinical trials currently or within 4 weeks prior
  • Received more than 4 cycles of systemic chemotherapy alone or combined with immunotherapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cancer hospital, CAMS

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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