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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 2

Conditions: Esophageal Cancer; Chemoradiotherapy; Unresectable Malignant Neoplasm; Nimotuzumab

Treatments: Drug: S-1; Drug: Nimotuzumab; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04207918

19/291-2075

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Neoadjuvant Chemoradiotherapy（NCRT）

Experimental group

Description:

NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）.

Treatment:

Drug: S-1

Radiation: Radiotherapy

Drug: Nimotuzumab