Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy in Resectable Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Neoadjuvant Treatment of Nimotuzumab With Chemotherapy or Radiotherapy Versus Surgery Alone in Resectable Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02272699
• Other study ID #: ESCC002
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: November 2014
• Est. completion date: December 2020

Study information

• Verified date: March 2021
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Esophageal cancer is one of common malignant tumors in China and esophageal squamous cell carcinoma (ESCC) is the dominant pathological type, accounting for more than 95% of all cases. One of our phase Ⅱ study introduced a combination treatment of an anti epithelial growth factor receptor (EGFR) agent, nimotuzumab, with paclitaxel and cisplatin as first-line treatment in unresectable or metastatic ESCC. The results showed that the overall response rate was 51.8% (29/56) and disease control rate was 92.9% (52/56). As a median follow-up of 24 months, the median progression-free survival for patients with metastatic disease and local advanced disease were 8.2 months and more than 23 months respectively. The overall survival for patients with metastatic disease was 13.9 months. It implied that as first-line chemotherapy, an addition of nimotuzumab to chemotherapy was a more active treatment option compared to other regimens published in previous studies. Investigations by Liang, J. and Ling, Y. also suggested that nimotuzumab in combining with radiotherapy or chemotherapy also showed anti-tumor activities and limited toxicities.

Therefore, we initiated this phase Ⅱ to Ⅲ clinical trial in which combining neoadjuvant treatments of nimotuzumab with chemotherapy or nimotuzumab with radiotherapy are compared with surgery alone for resectable stage Ⅱa to Ⅲ middle and lower thoracic esophageal squamous cell carcinoma patients. We hope to explore if these neoadjuvant combination treatments could bring survival benefit for ESCC patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.

• Weight loss must be less than 10% in last 6 months.

• With an expected life expectancy of = 12 months

• With a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale

• Patients must have histologically confirmed esophageal squamous cell carcinoma without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment.

• With resectable disease of primary tumor in middle or lower thoracic esophagus and clinical stage ?a-?.

• With measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

• Without serious system dysfunction and could tolerate chemotherapy or radiotherapy.

• Patients must have normal marrow function with a hemoglobin (HGB) of =90g/L, an white blood cell (WBC) counts of =4.0×109/L,a neutrophil count of =2.0×109/L, , a platelet count of =100×109/L, a total bilirubin (TBil) of =1.5 upper normal limitation (UNL), a creatinine (Cr) of = 1.5 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of =2.5 UNL.

• Patients must have normal electrocardiogram results and no history of congestive heart failure.

• Women of childbearing age should voluntarily take contraceptive measures.

• Without drug addition

• Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria:

• Allergic to known drug

• Patients who have received prior treatment including chemotherapy, radiotherapy and surgery.

• With unresectable disease including any T4b or M1 disease.

• Without measurable or evaluable disease.

• With history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years.

• With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.

• With neurological or psychiatric abnormalities that affect cognitive.

• Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Nimotuzumab
Nimotuzumab 200mg per week for 6 weeks.
• Paclitaxel
Paclitaxel 175mg per square metre on day 1, repeated every 3 weeks for 2 cycles.
• Cisplatin
Cisplatin 30mg per square metre on day 1 and day 2, repeated every 3 weeks for 2 cycles.

Radiation:
• Radiation
IMRT of primary tumor and local lymph nodes with 95% PTV of 41.4 Gy/23f. Nimotuzumab 200mg per week for 6 weeks.

Procedure:
• Surgery
Esophagectomy

Locations

Country	Name	City	State
China	Beijing Cancer Hospital & Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	From the date of randomization until the date of first documented relapse of disease or date of death from any cause, whichever came first. An expected average of 2 years.	2 years
Secondary	Overall survival	From the date of randomization until the date of death from any cause. An expected average of 3 years.	3 years
Secondary	Pathological complete response of neoadjuvant treatment	From the date of randomization until the date of pathological diagnosis is reported after esophagectomy. An expected average of 4 months.	4 months
Secondary	The R0 resection rate	From the date of randomization to one week after the surgical resection of tumor (esophagectomy). An expected average of 3 months.	3 months
Secondary	Numbers of adverse events and the degree of each adverse events according to the NCI CTCAE 4.0 criteria.	From the date of randomization to 3 months after esophagectomy. An expected average of 6 months.	6 months