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Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

Primary Purpose

Esophageal Carcinoma

Status
Enrolling by invitation
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Tigio
Concurrent radiation therapy
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Carcinoma focused on measuring Nimotuzumab, Concurrent chemoradiotherapy, Locally advanced esophageal cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Locally advanced senile esophageal cancer that cannot be treated surgicallyr (T3-4N0 or any N+); The pathological type is esophageal squamous cell carcinoma; immunohistochemistry showed medium and strong expression of EGFR; No signs of perforation, such as protruding spikes, niche shadow formation, twisted angles and mediastinal disorder; Karl Fischer score (KPS) ≥ 70, age ≥ 70 years old, can eat a semi-liquid diet; No serious comorbidities, such as severe obstructive emphysema, hypertension, coronary heart disease, diabetes and psychiatric history, etc., and no other malignant tumors; All patients had not received EGFR-targeted therapy, immunotherapy, and chemoradiotherapy. Exclusion Criteria: -

Sites / Locations

  • The First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab combined with concurrent chemoradiotherapy

Arm Description

Treatment options Nimotuzumab (400mg plus normal saline 250ml intravenous infusion for not less than 60 minutes. Starting from week 1 of radiotherapy, 1 dose of the same dose each time for a total of 6 doses)combined with chemoradiotherapy (Oral chemotherapy with the tigio regimen is given on days 1 to 2 of radiotherapy, with the drug dose calculated based on body surface area, and the oral tigio course from Monday to Friday is synchronized with radiation therapy) for the treatment of locally advanced elderly esophageal cancer patients, in which the tigio regimen with good clinical tolerability was selected for chemotherapy to evaluate the short-term efficacy and toxic side effects

Outcomes

Primary Outcome Measures

Overall Survival
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

Secondary Outcome Measures

complete response,CR
After treatment, the lesion completely disappears, or all symptoms and signs of the unmeasurable lesion completely disappear, and the lesion completely disappears in X-ray and bone imaging examinations for bone metastasis, lasting for at least 4 weeks
partial response,PR
The sum of the maximum diameters of the target lesion decreases by more than 30% and lasts for more than 4 weeks.
no response,NR
At the end of radiotherapy, there is residual tumor or no significant improvement in the lesion, but there are still significant filling defects and worsening of niche or stenosis
Toxic side reactions
The US Toxicity Evaluation Standard (CTC3. O) is divided into O~4 grades, and the evaluation of acute radiation reactions adopts RTOG/EROTC criteria

Full Information

First Posted
March 16, 2023
Last Updated
September 19, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT06048913
Brief Title
Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
Official Title
Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The research subjects of this project are mainly aimed at patients with locally advanced esophageal cancer who cannot be treated surgically, in Taixinsheng 3 months after the end of concurrent chemoradiotherapy, RECIST is pressed as based on physical examination and esophageal barium dialysis or esophageal contrast-enhanced CT Criteria assessed short-term and long-term efficacy separately. By detecting the expression of EGFR in patients with locally advanced esophageal cancer, the relationship between the efficacy of EGFR monoclonal antibody therapy and the long-term prognosis of patients was evaluated. Evaluation of safety, toxicity and side effects during treatment and in the near and long term.
Detailed Description
It is expected that 45 patients will be enrolled, and patients who meet the enrollment criteria will undergo esophagoscopy, esophageal barium meal examination, chest contrast-enhanced CT, abdominal ultrasound, electrocardiogram, blood routine, whole body bone scan, liver and kidney function and other examinations before treatment, and esophageal ultrasound if necessary. Patients who received esophageal ultrasound were staged by esophageal ultrasound results, and those without esophageal ultrasound were mainly staged according to the cervical chest and epigastric contrast CT and esophageal barium plates, and clinical staging was performed according to the 2002 AJCC staging standard. After the combination of Taixinsheng and concurrent chemoradiotherapy, adverse reactions and efficacy evaluation were observed. The expected result is that the local control rate of EGFR monoclonal antibody combined with chemoradiotherapy is improved in patients with locally advanced elderly esophageal squamous cell carcinoma, and there is no significant increase in adverse reactions, and serological indicators such as EGFR can be used as prognostic indicators for esophageal malignancy and have certain guiding significance for treatment. EGFR monoclonal antibody can be used in locally advanced elderly esophageal cancer patients who cannot tolerate chemotherapy, with good short-term efficacy and tolerable toxic side effects, which further provides reference value for clinical guidance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma
Keywords
Nimotuzumab, Concurrent chemoradiotherapy, Locally advanced esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab combined with concurrent chemoradiotherapy
Arm Type
Experimental
Arm Description
Treatment options Nimotuzumab (400mg plus normal saline 250ml intravenous infusion for not less than 60 minutes. Starting from week 1 of radiotherapy, 1 dose of the same dose each time for a total of 6 doses)combined with chemoradiotherapy (Oral chemotherapy with the tigio regimen is given on days 1 to 2 of radiotherapy, with the drug dose calculated based on body surface area, and the oral tigio course from Monday to Friday is synchronized with radiation therapy) for the treatment of locally advanced elderly esophageal cancer patients, in which the tigio regimen with good clinical tolerability was selected for chemotherapy to evaluate the short-term efficacy and toxic side effects
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Other Intervention Name(s)
taixinsheng
Intervention Description
Nimotuzumab 400mg plus normal saline 250ml intravenous infusion for not less than 60 minutes. Starting from week 1 of radiotherapy, 1 dose of the same dose each time for a total of 6 doses. The use of Taixinsen is not interrupted due to interruption of radiotherapy during the administration until the end of radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Tigio
Other Intervention Name(s)
chemotherapy
Intervention Description
Oral chemotherapy with the tigio regimen is given on days 1 to 2 of radiotherapy, with the drug dose calculated based on body surface area, and the oral tigio course from Monday to Friday is synchronized with radiation therapy.
Intervention Type
Radiation
Intervention Name(s)
Concurrent radiation therapy
Other Intervention Name(s)
Chemoradiotherapy
Intervention Description
Outline the target area layer by layer on the enhanced CT image, PGTV, PTV. The endangered organs are delineated layer by layer on the cross-section, and extended 0.3cm to form a corresponding plan to endanger the organs. The reverse intensity modulated radiotherapy plan was designed on the Monaco treatment plan system, with a prescribing dose of 56Gy/30F for PTV and 60Gy/30F for pGTV, and the target dose distribution and organ exposure dose were evaluated layer by layer on a cross-sectional surface, and combined with dose-to-volume histogram (DVH) evaluation and optimal treatment plan, the maximum dose of radiation in the spinal cord < 40 Gy and lung V20<30%. After the treatment plan is confirmed, the dose is verified on the treatment machine, and the treatment plan is executed after it is accurate. govern
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
complete response,CR
Description
After treatment, the lesion completely disappears, or all symptoms and signs of the unmeasurable lesion completely disappear, and the lesion completely disappears in X-ray and bone imaging examinations for bone metastasis, lasting for at least 4 weeks
Time Frame
through study completion, an average of 18 month
Title
partial response,PR
Description
The sum of the maximum diameters of the target lesion decreases by more than 30% and lasts for more than 4 weeks.
Time Frame
through study completion, an average of 18 month
Title
no response,NR
Description
At the end of radiotherapy, there is residual tumor or no significant improvement in the lesion, but there are still significant filling defects and worsening of niche or stenosis
Time Frame
through study completion, an average of 18 month
Title
Toxic side reactions
Description
The US Toxicity Evaluation Standard (CTC3. O) is divided into O~4 grades, and the evaluation of acute radiation reactions adopts RTOG/EROTC criteria
Time Frame
through study completion, an average of 18 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Locally advanced senile esophageal cancer that cannot be treated surgicallyr (T3-4N0 or any N+); The pathological type is esophageal squamous cell carcinoma; immunohistochemistry showed medium and strong expression of EGFR; No signs of perforation, such as protruding spikes, niche shadow formation, twisted angles and mediastinal disorder; Karl Fischer score (KPS) ≥ 70, age ≥ 70 years old, can eat a semi-liquid diet; No serious comorbidities, such as severe obstructive emphysema, hypertension, coronary heart disease, diabetes and psychiatric history, etc., and no other malignant tumors; All patients had not received EGFR-targeted therapy, immunotherapy, and chemoradiotherapy. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaolin GE, PhD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

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