A Phase III Study of Nimotuzumab Plus Concurrent Chemoradiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 21, 2021
  • participants needed
    200
  • sponsor
    Shandong Cancer Hospital and Institute
Updated on 21 January 2021

Summary

Esophageal cancer is the sixth leading cause of cancer death in worldwide. Over the past 2 decades, well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer, either as primary therapy or in neoadjuvant setting. Paclitaxel, a radiation sensitizer, has important single-agent activity in esophageal cancer. Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group (RTOG) trials of nonoperative management of esophageal cancer. Accumulating clinical evidence suggests that Epidermal Growth Factor Receptor (EGFR) represents a viable target in the treatment of esophageal cancer. EGFR expression is associated with poor prognosis. Nimotuzumab binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor (EGF) and other ligands, such as Transforming Growth Factor- (TGF-). Preclinical models have suggested synergy between nimotuzumab, paclitaxel, cisplatin and radiation. For our phase II study in locally advanced esophageal squamous cell carcinoma (ESCC), the combination of cetuximab and chemoradiotherapy has demonstrated both response and survival benefits. Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy (CCRT) was safe and provided statistically significant objective response (47.8%) and disease control rate (60.9%) in nonresectable ESCC. With all these, the investigators plan to study phase III trial.

Description

The primary endpoint of this study is overall survival, and the primary hypothesis is the experimental arm will improve median survival time (MST) from 18.2 month to 28.5 month. Assuming bilateral = 0.05, statistical power of 80%.Each group requires a minimum of 59 cases. Consider the 20% loss factor.The total sample size is 200 cases.It is 100 cases in each group.

Details
Condition Prosthesis Survival
Treatment Radiotherapy, Placebo, Nimotuzumab, chemoradiotherapy Paclitaxel, chemoradiotherapy Cisplatin
Clinical Study IdentifierNCT02409186
SponsorShandong Cancer Hospital and Institute
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Prosthesis Survival?
Do you have any of these conditions: Do you have Prosthesis Survival??
Signed written informed consent prior to study entry
age18-70 years
Histopathology confirmed primary esophageal squamous cell carcinoma, meet one of the following criteria (AJCC Staging System2009Seventh Edition):Cervical esophageal carcinoma(stage II-III);upper thoracic esophageal cancer or chest esophageal cancer that is unsuitable or refuse surgery (stage II-III)
The existence of measurable lesions (according to Response Evaluation Criteria in Solid Tumors 1.1)
Eastern Cooperative Oncology GroupECOGPerformance status of 0-1
Possible semi-liquid diet
If there is a risk of pregnancy, male and female subjects must be effective contraception during treatment
Normal bone marrow reserve: neutrophil (ANC) count1500/mm3,platelet count100,000 /mm3, hemoglobin5.6mmol/L(9g/dL)
Normal renal function: serum creatinine1.5mg/dl and/or calculated creatinine clearance 60ml/min
Normal hepatic function: bilirubin level1.5ULN, alanine aminotransferase aspartate transaminaseASAT& ALST1.5ULN
Subjects tumor tissue available for the relevant biomarker detection

Exclusion Criteria

Previous chest radiotherapy, systemic chemotherapy, and major esophageal surgery
Concurrent chronic systemic immune therapy, targeted therapy, anti-vascular endothelial growth factorVEGFtherapy or EGFR-pathway targeting therapy not indicated in this study protocol
Multiple primary carcinomas of the esophagus
Pregnancy (confirmed by urine -HCG) or lactation period
Uncontrolled diabetes, hypertension, and severe cardiac or pulmonary disease
There are obvious esophageal ulcers, chest and back more than moderate pain, symptoms of esophageal perforation
Unable to comprehend the study requirements or who are not likely to comply with the study requirements
Patients with distant metastasis
Patients with other malignant disease, except for curable non-melanoma skin cancer, cervical carcinoma in situ or malignant disease cure for5 years
Known grade 3 or 4 allergic reaction to any of the study treatment
Peripheral neuropathy > grade 1
Participation in another clinical study within the past 30 days
Significant disease which, in the investigator's opinion, would exclude the patient from the study
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