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

It is expected that 52 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 nimotuzumab 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.

Inclusion criteria

• Patients with stage II-IVB according to AJCC (8th edition, 2018) (IVB included metastasis to the celiac trunk or supraclavicular lymph nodes only) who are not suitable for or refuse surgery can tolerate concurrent chemoradiotherapy and targeted therapy;
• The pathological type is esophageal squamous cell carcinoma;
• Eastern Cooperative Oncology Group performance status of 0-1, age ≥ 75 years old;
• 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;
• Expected survival time ≥ 12 weeks.

Exclusion criteria

Patients who meet any of the following criteria will be excluded from this trial:

• Received EGFR monoclonal antibody or EGFR-TKI within six months;
• Participated in other interventional clinical trials within 30 days before screening;
• Patients with serious concurrent diseases, such as heart failure, high-risk uncontrollable arrhythmias, severe myocardial infarction, refractory hypertension, renal failure (CKD-4 and above), thyroid dysfunction, mental illness, diabetes, severe chronic diarrhea (more than 7 bowel movements per day), or patients who are considered unsuitable to participate in this clinical study by the researchers;
• Patients with brain metastases with symptoms or symptom control time of less than 3 months;
• Having a history of other malignant tumors (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin and other malignant tumors that have been cured for more than 5 years);
• The presence of active infection or active infectious disease;
• Patients with multi-segment esophageal malignant tumors or signs of esophageal fistula or perforation;
• Patients whose tumors have invaded important blood vessels as shown by imaging or who are judged by the researchers to be very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study;
• Those who are allergic to the drugs or their ingredients used in this program;
• Peripheral neuropathy or hearing loss of grade 2 or higher according to the criteria of Common Terminology for Adverse Events (NCI CTCAE V5.0);
• Pregnant or breastfeeding women;
• Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders;
• Those who are considered unsuitable to participate in this study by the researcher;
• Those who are unwilling to participate in this study or unable to sign the informed consent.