A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207918
• Other study ID #: 19/291-2075
• Status: Completed
• Phase: Phase 2
• Start date: November 14, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II clinical study is designed to evaluate the 1 year local tumor control rates after the targeted therapy of intensity-modulated radiation therapy synchronized chemotherapy with nimotuzumab combined with S-1 in local advanced esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years

• Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)

• Primary treatment accepted in Chinese Academy of Medical Sciences

• KPS =70

• NRS score =2

• Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma

• Normal organ and marrow function as defined below:

Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit

• Informed consent

Exclusion Criteria:

• Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer

• Any prior chemotherapy or other cancer treatment prior to this protocol

• With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation

• History of allergic reactions attributed to contrast medium, similar chemical or biologic complex

• Existing esophageal fistula, perforation and cachexia

• Existing active infection such as active tuberculosis and hepatitis

• Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness

• History of myocardial infarction within the past 6 months or history of ventricular arrhythmia

• Participation in other clinical trials currently or within 4 weeks of selection

• Pregnant or lactating females

Related Conditions & MeSH terms

• Chemoradiotherapy
• Esophageal Cancer
• Esophageal Neoplasms
• Neoplasms
• Nimotuzumab
• Unresectable Malignant Neoplasm

Intervention

Radiation:
• Radiotherapy
44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment.

Drug:
• Nimotuzumab
400mg, by intravenous infusion once a week in 4-6 weeks.
• S-1
40-60mg/m2/d,orally twice a day concurrently with radiotherapy.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate		1 year
Secondary	Number of Participants with acute toxicities	Acute toxicities are evaluated by NCI-CTC version 5.0	2-3 months
Secondary	R0 resection rate	The surgical procedure was radical esophagectomy after neoadjuvant therapy.	2-3 months
Secondary	Pathological response rate	Pathological response were classified into five grades according to Mandard Tumor Regression Grade.	2-3 months
Secondary	Tumor Response rate		2-3 months
Secondary	Incidence of perioperative complications	During hospital stay and within the first 30 days after completion of surgery.	2-3 months
Secondary	Overall survival		1 year, 2 year
Secondary	Progression free survival		1 year, 2 year
Secondary	Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis		1 year, 2 year
Secondary	ctDNA in predicting tumor response rate and prognosis		1 year, 2 year