Efficacy and Safety of PD-1 Inhibitor Combined With Radiotherapy in Treatment of Elderly Esophageal Squamous Cell Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• 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 ≥ 3 months

• Karnofsky performance score ≥70

• 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

Locations
Other Locations
China
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Contact Information
Primary
Yu Weiwei
yww333@126.com
18930174528
Backup
Song Haotian
sht980212@163.com
19827031325
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 68
Treatments
Experimental: Experiment Arm
PD-1 inhibitor combined with radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Affiliated Hospital of Nantong University

This content was sourced from clinicaltrials.gov