NCT06988956 Nimotuzumab Plus Definite Chemoradiotherapy(dCRT) in Elderly Patients With Esophageal Squamous Cell Carcinoma
| NCT ID | NCT06988956 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2024-03-31 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 95 participants in total. It began in 2024-03-31 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
investigators plan to conduct a multicenter, prospective, randomized controlled, open, phase clinical study to compare the efficacy and safety of nimotuzumab with concurrent chemoradiation alone in elderly participants with advanced esophageal squamous cell carcinoma.
Eligibility Criteria
Inclusion Criteria: 1. The subject volunteered to join the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 2. Age 70 or above, male or female; 3. The ECOG score is 0-1 point; 4. Oesophageal squamous cell carcinoma diagnosed by histology or cytology; 5. According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), at least one measurable lesion, and the measurable lesion should not receive local treatment such as radiotherapy (the lesion located in the previous radiotherapy area can also be selected if the progression is confirmed and meets the RECIST1.1 criteria); 6. Stage II-IVB (IVB stage only includes supraclavicular/abdominal lymph node metastasis, does not include any other distant metastasis), can tolerate synchronous radiotherapy, chemotherapy, and targeted therapy 7. Expected survival time of 6 months; 8. Main organ function is normal, that is, meet the following criteria: 1\) Blood routine examination: 1. HBG≥90g/L； 2. ANC≥1.5×109/L； 3. PLT ≥80×109/L； 2) Biochemical examination: a.ALB≥30g/L； B. ALT and AST≤2.5ULN; ALT and AST 5 ULN; c.TBIL≤1.5ULN； D. Plasma Cr≤1.5ULN or creatinine clearance (CCr) of 60 ml/min; 9. Echocardiographic assessment: left ventricular ejection fraction (LVEF) low normal value (50%); 10. Women of childbearing age should agree to use contraception (e. g. intrauterine devices, contraceptives or condoms) during the study and within 6 months after the study; serum or urine pregnancy tests were negative within 7 days before study enrollment and must be non-lactating patients; men who agree to use contraception during the study and within 6 months after the end of the study period. Exclusion Criteria: 1. Received EGFR mAb and EGFR-TKI within half a year; 2. Participated in other interventional clinical trials within 30 days before screening; 3. Have serious concurrent diseases, such as heart failure, high risk of uncontrolled arrhythmia, severe myocardial infarction, intractable hypertension, renal failure (CKD-4 and above), thyroid insufficiency, mental illness, diabetes, severe chronic diarrhea (more than 7 times a day) and the researchers think not suitable to participate in the clinical research; 4. Patients with brain metastases with symptoms or symptom control time for less than 3 months; 5. 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); 6. presence of active infection or active infectious diseases; 7. The presence of multilevel esophageal malignancy or signs of esophageal fistula and perforation; 8. Patients whose imaging shows that the tumor has invaded important blood vessels or whose tumor is likely to invade important blood vessels during the subsequent study; 9. Those allergic to the use of drugs or their ingredients in this regimen; 10. Grade 2 peripheral neurological disease or hearing loss according to the criteria of common adverse event terms (NCI CTCAE V5.0); 11. Pregnant or lactating women; 12. Patients with a history of psychiatric substance abuse and unable to quit or with mental disorders; 13. The investigator is not considered fit to join the investigator; Unwilling to participate in the study or unable to sign the informed consent form
Contact & Investigator
Xiaolin MM GE
STUDY DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06988956 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06988956 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06988956 currently recruiting?
Yes, NCT06988956 is actively recruiting participants. Contact the research team at doctorsxl@163.com for enrollment information.
Where is the NCT06988956 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06988956 clinical trial?
NCT06988956 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Xiaolin MM GE at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 95 participants.