Nimotuzumab combined with chemoradiotherapy for elderly patients with esophageal cancer

A Prospective, Randomized Controlled, Open Label, Multicenter, Phase II Clinical Study Evaluating the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy in Elderly Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

This study is testing if adding a new drug called nimotuzumab to standard treatment helps older patients with advanced esophageal cancer feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (estimated)
• Ages: 75 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy, nimotuzumab
• Locations: 1 site (Nanjing)
• Trial ID: NCT06988956 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of nimotuzumab in combination with concurrent chemoradiotherapy in elderly patients diagnosed with advanced esophageal squamous cell carcinoma. Participants aged 70 and above will be randomly assigned to receive either nimotuzumab with radiotherapy or standard treatment with Tegafur and radiotherapy. The study will include a screening period, treatment period, and follow-up for efficacy and survival outcomes. It is designed as a multicenter, prospective, randomized controlled trial to provide robust data on treatment effectiveness.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 70 and above with a diagnosis of advanced esophageal squamous cell carcinoma and good overall health.

Not a fit: Patients with distant metastasis beyond supraclavicular or abdominal lymph node involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and quality of life for elderly patients with advanced esophageal squamous cell carcinoma.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific combination is being evaluated for the first time in this demographic.

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

Where this trial is running

Nanjing

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, China (Recruiting)

Study contacts

• Study coordinator: Xiaolin MM GE, PHD

Conditions Esophageal Squamous Cell Carcinoma; Nimotuzumab