Nimotuzumab Plus Definite Chemoradiotherapy(dCRT) in Elderly Patients With Esophageal Squamous Cell Carcinoma

Официальное название

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

Обзор

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.

Подробное описание

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. The enrolled participants will be randomly ized into the trial and control group according to 1:1. The test group received nimotuzumab and radiotherapy; the control group received Tigio and radiotherapy. This study includes the screening period, treatment period, efficacy follow-up period, and survival follow-up period

Вмешательства

• Препарат Nimotuzumab
  Nimotuzumab 400mg
• Препарат Tegafur
  S-1 60mg/m2
• Лучевая терапия radiotherapy
  PTV 50Gy/2Gy

Первичные конечные точки

• PFS [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]

Критерии участия

Критерии включения

• The subject volunteered to join the study, signed the informed consent form, had good compliance, and cooperated with the follow-up;
• Age 70 or above, male or female;
• The ECOG score is 0-1 point;
• Oesophageal squamous cell carcinoma diagnosed by histology or cytology;
• 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);
• 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
• Expected survival time of 6 months;
• Main organ function is normal, that is, meet the following criteria:

1\) Blood routine examination:

• HBG≥90g/L；
• ANC≥1.5×109/L；
• 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.

Критерии исключения

• Received EGFR mAb and EGFR-TKI within half a year;
• Participated in other interventional clinical trials within 30 days before screening;
• 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;
• Patients with brain metastases with symptoms or symptom control time for less than 3 months;
• 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);
• presence of active infection or active infectious diseases;
• The presence of multilevel esophageal malignancy or signs of esophageal fistula and perforation;
• 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;
• Those allergic to the use of drugs or their ingredients in this regimen;
• Grade 2 peripheral neurological disease or hearing loss according to the criteria of common adverse event terms (NCI CTCAE V5.0);
• Pregnant or lactating women;
• Patients with a history of psychiatric substance abuse and unable to quit or with mental disorders;
• The investigator is not considered fit to join the investigator; Unwilling to participate in the study or unable to sign the informed consent form

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT06988956 · IST-Nim-ESCC-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗