NCT06048913CompletedPhase 2
Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age
Source: ClinicalTrials.gov · Last updated 4 Jul 2025
Brief summary (registry, in English)
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 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 16 Mar 2023
- Start date
- 1 Dec 2020
- Primary completion date
- 1 Jan 2025
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06048913
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 56
- From 1 Dec 2020 to the primary completion date, 1 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
- Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders;
Lab values
- Received EGFR monoclonal antibody or EGFR-TKI within six months;
Other
- Patients who meet any of the following criteria will be excluded from this trial:
- Patients with brain metastases with symptoms or symptom control time of less than 3 months;
- 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;
- 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.
Who the study is looking for
- 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.
Age in the registry: 75 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.