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

Phase 2

Completed

• Conditions: Chemoradiotherapy; Esophageal Cancer; Unresectable Malignant Neoplasm; Nimotuzumab
• Interventions: Radiation: Radiotherapy; Drug: Nimotuzumab; Drug: S-1

• Registration Number: NCT04207918
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-14
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Primary Completion: 2022-12-30
• Study Completion: 2023-06-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Chemoradiotherapy（NCRT）	Radiotherapy	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）.
Neoadjuvant Chemoradiotherapy（NCRT）	Nimotuzumab	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）.
Neoadjuvant Chemoradiotherapy（NCRT）	S-1	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）.

Primary Outcome Measures

Name	Time	Method
Local control rate	1 year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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, China