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

Primary Purpose

Esophageal Cancer, Chemoradiotherapy, Nimotuzumab

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Nimotuzumab
S-1
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • 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)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant Chemoradiotherapy（NCRT）

Arm 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）.

Outcomes

Primary Outcome Measures

Local control rate

Secondary Outcome Measures

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

Full Information

First Posted
December 19, 2019
Last Updated
October 21, 2021
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04207918
Brief Title
A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer
Official Title
A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Squamous Cell Carcinoma Based on Nutritional Risk Screening Score (NRS2002)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Chemoradiotherapy, Nimotuzumab, Unresectable Malignant Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant Chemoradiotherapy（NCRT）
Arm Type
Experimental
Arm 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）.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
400mg, by intravenous infusion once a week in 4-6 weeks.
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
40-60mg/m2/d，orally twice a day concurrently with radiotherapy.
Primary Outcome Measure Information:
Title
Local control rate
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Participants with acute toxicities
Description
Acute toxicities are evaluated by NCI-CTC version 5.0
Time Frame
2-3 months
Title
R0 resection rate
Description
The surgical procedure was radical esophagectomy after neoadjuvant therapy.
Time Frame
2-3 months
Title
Pathological response rate
Description
Pathological response were classified into five grades according to Mandard Tumor Regression Grade.
Time Frame
2-3 months
Title
Tumor Response rate
Time Frame
2-3 months
Title
Incidence of perioperative complications
Description
During hospital stay and within the first 30 days after completion of surgery.
Time Frame
2-3 months
Title
Overall survival
Time Frame
1 year, 2 year
Title
Progression free survival
Time Frame
1 year, 2 year
Title
Texture analysis of CT and/or MRI simulation in predicting tumor response rate and prognosis
Time Frame
1 year, 2 year
Title
ctDNA in predicting tumor response rate and prognosis
Time Frame
1 year, 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Wang, MD
Phone
+861013311583220
Email
beryl_wx2000@163.com
Facility Information:
Facility Name
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)
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, MD
Phone
+861013311583220
Email
beryl_wx2000@163.com

12. IPD Sharing Statement

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

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