PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC

• Status: Recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of Nantong University
• Treatments: Immune Checkpoint Inhibitors

Criteria

Inclusion Criteria:

1. Patients aged 70 years or above

2. Treatment naive patients with pathology proven esophageal squamous cell carcinoma that was inoperable or refuse surgery and who could not tolerate concurrent chemoradiotherapy

3. Stage II-IVa according to the AJCC TNM staging system

4. Estimated survival time ≥ 3 months

5. Karnofsky performance score ≥70

6. Normal blood routine, liver and kidney function less than 2 times of the normal upper limit

7. Without mental disorders, cooperate with treatment and follow-up

8. Have fully understood this study and voluntarily signed the informed consent

Exclusion Criteria:

1. Esophageal bronchial fistula or esophageal mediastinal fistula

2. Patients who have participated in other clinical trials before this treatment

3. Severe heart, liver and/or kidney dysfunction

4. Serious infectious diseases

5. EC who has received surgery, chemotherapy,PD-1 inhibitor or radiotherapy

6. Severe autoimmune disease

7. Relapse disease or distant metastasis

8. Combined with other malignant tumors.