BridgeMD
New treatment option for Esophageal Squamous Cell Carcinoma
Official title Nimotuzumab Plus Definite Chemoradiotherapy(dCRT) in Elderly Patients With Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06988956
What this study is testing
What is Nimotuzumab?
Nimotuzumab is an investigational medicine, being studied as a potential treatment for esophageal squamous cell carcinoma.
Also referred to as Nim.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 75 and older
You may be able to join if
- 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 how well it works evaluation criteria of solid tumors (RECIST 1.1), at least one measurable lesion, and the measurable lesion should...
You likely can't join if
- Received EGFR mAb and EGFR-TKI within half a year;
- Participated in other treatment clinical trials within 30 days before screening;
- Have serious concurrent diseases, such as heart failure, high risk of uncontrolled arrhythmia, severe myocardial infarction, intractable...
- 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...
- presence of active infection or active infectious diseases;
See the full eligibility criteria
- 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 how well it works 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...
- 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...
- Received EGFR mAb and EGFR-TKI within half a year;
- Participated in other treatment 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 75 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.