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

Phase 1

• Conditions: Esophageal Carcinoma
• Interventions: Drug: Nimotuzumab; Drug: Tigio; Radiation: Concurrent radiation therapy

• Registration Number: NCT06048913
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-03-16
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab combined with concurrent chemoradiotherapy	Tigio	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
Nimotuzumab combined with concurrent chemoradiotherapy	Concurrent radiation therapy	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
Nimotuzumab combined with concurrent chemoradiotherapy	Nimotuzumab	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

Primary Outcome Measures

Name	Time	Method
Overall Survival	up to 3 years	Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

Secondary Outcome Measures

Name	Time	Method
complete response，CR	through study completion, an average of 18 month	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	through study completion, an average of 18 month	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	through study completion, an average of 18 month	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	through study completion, an average of 18 month	The US Toxicity Evaluation Standard (CTC3. O) is divided into O\~4 grades, and the evaluation of acute radiation reactions adopts RTOG/EROTC criteria

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China