RecruitingPhase 2NCT06186609

PD-1 Inhibitor Combined With Radiotherapy for Elderly ESCC

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

Sponsor

Affiliated Hospital of Nantong University

Enrollment

68 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

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

Min Age: 70 Years

Inclusion Criteria8

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

Exclusion Criteria8

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
EC who has received surgery, chemotherapy,PD-1 inhibitor or radiotherapy
Severe autoimmune disease
Relapse disease or distant metastasis
Combined with other malignant tumors.

Interventions

DRUGPD-1 inhibitor 200mg per three to four weeks, for one year

PD-1 inhibitor delivered 200mg once before radiotherapy and 200mg every 3-4 weeks after radiotherapy for one year. Radiotherapy:56-60Gy/28-30 fraction.