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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Unresectable Malignant Neoplasm; Chemoradiotherapy; Nimotuzumab
• Intervention / Treatment: Radiation: Radiotherapy; Drug: Nimotuzumab; Drug: S-1

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • 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)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant Chemoradiotherapy（NCRT）; 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）.	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.; Drug: S-1; 40-60mg/m2/d，orally twice a day concurrently with radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Local control rate	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms; Esophageal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: 19/291-2075

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No