NCT06342167

Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma

Efficacy and Safety of Concurrent Sintilimab and Radiotherapy With Immunonutrition Support in Esophageal Cancer: A Phase II Multicenter Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC). Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT.

Detailed description

This single-arm trial is designed to evaluate the efficacy and safety of concurrent immunotherapy (sintilimab) plus radiotherapy with immunonutrition support (enteral nutritional emulsion (TPF-T) followed by consolidation immunotherapy in inoperable patients with locally advanced or early stage esophageal squamous cell carcinoma , who are PD-L1 positive expression and intolerant to cCRT. The eligible patients will receive concurrent treatment consisting of total dose of 50-60 Gy in 25-30 fractions and 200 mg of sintilimab administered every three weeks, along with enteral nutritional emulsion (TPF-T) support (600-1600 ml per day according to the nutrition status evaluation). The primary outcome is 1-year progression-free survival (PFS) rate. The investigators hypothesized PD-L1 inhibitor plus radiotherapy will improve the 1-year PFS from 40% to 60%. Then, 58 patients will be needed in total. The secondary outcomes will include objective response rate (ORR), overall survival (OS), progression-free and overall survival, and incidence of adverse events. This study is approval by the National GCP Center for Anticancer Drugs, Independent Ethics Committee, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College (Study ID: 24/074-4354).

Conditions

• Locally Advanced Esophageal Squamous Cell Carcinoma
• Sintilimab
• Radiotherapy
• Concurrent Chemoradiotherapy
• Immunonutrition

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Interventions consist of 50-60 Gy in 25-30 fractions of radiotherapy.
DRUG	Programmed Cell Death Protein 1 Inhibitor	200 mg of Sintilimab administered every three weeks concurrently with radiotherapy and after radiotherapy as consolidation therapy up to 1year.
DIETARY_SUPPLEMENT	Immunonutrition support	600-1600 ml of TPF-T per day according to the nutrition status evaluation

Timeline

• Start date: 2024-03-14
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2024-04-02
• Last updated: 2024-06-11

Locations

9 sites across 1 country: China