Status:
COMPLETED
Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Esophageal Carcinoma
Eligibility:
All Genders
75+ years
Phase:
PHASE2
Brief Summary
The research subjects of this project are mainly aimed at patients with locally advanced esophageal cancer who cannot be treated surgically, in nimotuzumab 3 months after the end of concurrent chemora...
Detailed Description
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 ul...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06048913
Start Date
December 1 2020
End Date
January 1 2025
Last Update
July 4 2025
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210009