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

• ClinicalTrials.gov Identifier: NCT06048913
• Recruitment Status: Enrolling by invitation
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Information provided by (Responsible Party): The First Affiliated Hospital with Nanjing Medical University

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.

Condition or disease	Intervention/treatment	Phase
Esophageal Carcinoma	Drug: Nimotuzumab; Drug: Tigio; Radiation: Concurrent radiation therapy	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
• Actual Study Start Date: July 1, 2022
• Estimated Primary Completion Date: July 1, 2025
• Estimated Study Completion Date: July 1, 2028

Arms and Interventions

Arm

Intervention/treatment

Experimental: Nimotuzumab combined with concurrent chemoradiotherapy; 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

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.; Other Name: taixinsheng; Drug: 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.; Other Name: chemotherapy; 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; Other Name: Chemoradiotherapy

Outcome Measures

Primary Outcome Measures :

1. Overall Survival [ Time Frame: 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 :

1. complete response，CR [ Time Frame: 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
2. partial response，PR [ Time Frame: 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.
3. no response，NR [ Time Frame: 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
4. Toxic side reactions [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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:

-

Contacts and Locations

Locations

China, Jiangsu

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210009

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

• Study Director: Xiaolin GE, PhD; The First Affiliated Hospital with Nanjing Medical University

More Information

• Responsible Party: The First Affiliated Hospital with Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT06048913
• Other Study ID Numbers: GXL-002
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by The First Affiliated Hospital with Nanjing Medical University:

Nimotuzumab; Concurrent chemoradiotherapy; Locally advanced esophageal cancer

Additional relevant MeSH terms:

Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Nimotuzumab; Antineoplastic Agents, Immunological; Antineoplastic Agents