Actively Recruiting

Phase 2
Age: 70Years +
All Genders
NCT06186609

PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC

Led by Affiliated Hospital of Nantong University · Updated on 2024-01-02

68

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Concurrent chemoradiotherapy is now considered to be the standard treatment modality for esophageal cancer patients who are medically unfit for surgery. However, elderly patients have limitations in their ability to tolerate concurrent chemoradiotherapy in comparison to nonelderly patients because of medical comorbidities and reduced functional reserve of organs. Immune checkpoint inhibitors, including PD-1 inhibitor, have been used in a large number of clinical studies on esophageal cancer and have achieved certain results. PD-1 inhibitor combined with radiotherapy may be a new strategy for elderly patients with esophageal cancer. This study aims to explore the efficacy and safety of PD-1 inhibitor combined with radiotherapy in the treatment of elderly patients with esophageal cancer. PD-1 inhibitor was delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year.

CONDITIONS

Official Title

PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 70 years or above
  • Treatment naive patients with pathology proven esophageal squamous cell carcinoma that was inoperable or refuse surgery and who could not tolerate concurrent chemoradiotherapy
  • Stage II-IVa according to the AJCC TNM staging system
  • Estimated survival time 6 3 months
  • Karnofsky performance score 670
  • Normal blood routine, liver and kidney function less than 2 times of the normal upper limit
  • Without mental disorders, cooperate with treatment and follow-up
  • Have fully understood this study and voluntarily signed the informed consent
Not Eligible

You will not qualify if you...

  • Esophageal bronchial fistula or esophageal mediastinal fistula
  • Patients who have participated in other clinical trials before this treatment
  • Severe heart, liver and/or kidney dysfunction
  • Serious infectious diseases
  • Esophageal cancer who has received surgery, chemotherapy, PD-1 inhibitor or radiotherapy
  • Severe autoimmune disease
  • Relapse disease or distant metastasis
  • Combined with other malignant tumors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China, 226001

Actively Recruiting

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Research Team

Y

Yu Weiwei

CONTACT

S

Song Haotian

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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