Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 1, 2020

Primary Completion Date

January 1, 2025

Study Completion Date

January 1, 2025

Conditions
Esophageal Carcinoma
Interventions
DRUG

Nimotuzumab

Nimotuzumab 400mg plus normal saline 250ml intravenous infusion for not less than 60 minutes. Starting from week 1 of radiotherapy, 1 dose of the same dose each time for a total of 6 doses. The use of nimotuzumab is not interrupted due to interruption of radiotherapy during the administration until the end of radiotherapy.

DRUG

S-1

Oral chemotherapy with the S-1 regimen is given on days 1 to 2 of radiotherapy, with the drug dose calculated based on body surface area, and the oral S-1 course from Monday to Friday is synchronized with radiation therapy.

RADIATION

Concurrent radiation therapy

Outline the target area layer by layer on the enhanced CT image, PGTV, PTV. The endangered organs are delineated layer by layer on the cross-section, and extended 0.3cm to form a corresponding plan to endanger the organs. The reverse intensity modulated radiotherapy plan was designed on the Monaco treatment plan system, with a prescribing dose of 56Gy/30F for PTV and 60Gy/30F for pGTV, and the target dose distribution and organ exposure dose were evaluated layer by layer on a cross-sectional surface, and combined with dose-to-volume histogram (DVH) evaluation and optimal treatment plan, the maximum dose of radiation in the spinal cord \< 40 Gy and lung V20\<30%. After the treatment plan is confirmed, the dose is verified on the treatment machine, and the treatment plan is executed after it is accurate. govern

Trial Locations (1)

210009

The First Affiliated Hospital of Nanjing Medical University, Nanjing

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER

NCT06048913 - Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age | Biotech Hunter | Biotech Hunter