Nimotuzumab combined with chemoradiotherapy for elderly patients with esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Xiaolin MM GE, PHD
• Email: doctorsxl@163.com
• Phone: 13951818797

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

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  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07858630

• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

  This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.

  Recruiting at 2 sites Phase 2 Shanghai Chest Hospital · Shanghai and 1 other locations · NCT07811752

• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

  This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• Immune Sandwich: Induction with Nimotuzumab and Toripalimab Plus Radiotherapy vs Full-Course Immunotherapy for Advanced Nasopharyngeal Cancer

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  Recruiting Phase 3 Sun Yat-sen University · Guangzhou, Guangdong · NCT07706985

• SKB500 combinations for esophageal squamous cell carcinoma

  This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.

  Recruiting at 24 sites Phase 2 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Changchun and 23 other locations · NCT07700667

• Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma

  This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.

  Recruiting Phase 2 Tongji Hospital · Wuhan, Hubei · NCT07699185

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.