Neoplasms

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Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Sintilimab + radiotherapy + enteral nutritional emulsion (TPF-T)

Interventions consist of 50-50.4 Gy in 25-28 fractions of radiotherapy.

Radiotherapy

200 mg of Sintilimab administered every three weeks concurrently with radiotherapy and after radiotherapy as consolidation therapy up to 1year.

Programmed Cell Death Protein 1 Inhibitor

600-1600 ml of TPF-T per day according to the nutrition status evaluation

Immunonutrition support

Jianyang Wang, MD

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.

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 patients with LA-ESCC and PD-L1 positive expression who are intolerant to cCRT. The eligible patients will receive concurrent treatment consisting of total dose of 50-50.4 Gy in 25-28 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).

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

Progression-free survival rate is defined the rate of progress event at 1-years after radiotherapy. Progression event is defined as event of primary tumor and regional recurrence, or distant metastasis

Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Progression-free survival is defined as the time from treatment to the event of primary tumor and regional recurrence, or distant metastasis

Adverse events are classified according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0) criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma	NCT06342167	Locally Advance... Sintilimab Radiotherapy Concurrent Chem... Immunonutrition	Radiotherapy Programmed Cell... Immunonutrition...	18 Years - 80 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma	NCT06342167	Locally Advance... Sintilimab Radiotherapy Concurrent Chem... Immunonutrition	Radiotherapy Programmed Cell... Immunonutrition...	18 Years - 80 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma	NCT06342167	Locally Advance... Sintilimab Radiotherapy Concurrent Chem... Immunonutrition	Radiotherapy Programmed Cell... Immunonutrition...	18 Years - 80 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Spots Global Cancer Trial Database for immunonutrition support