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

Esophageal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06048913
• Other study ID #: GXL-002
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: July 1, 2022
• Est. completion date: July 1, 2028

Study information

• Verified date: September 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. Locally advanced senile esophageal cancer that cannot be treated surgicallyr (T3-4N0 or any N+);

2. The pathological type is esophageal squamous cell carcinoma;

3. immunohistochemistry showed medium and strong expression of EGFR;

4. No signs of perforation, such as protruding spikes, niche shadow formation, twisted angles and mediastinal disorder;

5. Karl Fischer score (KPS) = 70, age = 70 years old, can eat a semi-liquid diet;

6. No serious comorbidities, such as severe obstructive emphysema, hypertension, coronary heart disease, diabetes and psychiatric history, etc., and no other malignant tumors;

7. All patients had not received EGFR-targeted therapy, immunotherapy, and chemoradiotherapy. Exclusion Criteria: -

Related Conditions & MeSH terms

• Esophageal Carcinoma
• Esophageal Neoplasms

Intervention

Drug:
• Nimotuzumab
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.
• Tigio
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.

Radiation:
• Concurrent radiation therapy
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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.	up to 3 years
Secondary	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	through study completion, an average of 18 month
Secondary	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.	through study completion, an average of 18 month
Secondary	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	through study completion, an average of 18 month
Secondary	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	through study completion, an average of 18 month