Clinical trial NCT02011594: Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma
Official title: Phase II Study of Maintenance Treatment of Nimotuzumab Versus No Maintenance for Advanced Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Stage IV Esophageal Squamous Cell Carcinoma
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy. However, whether maintenance therapy of nimotuzumab provides benefit to advanced esophageal cancer patients is not known.

Detailed description: We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.

Eligibility criteria: Inclusion Criteria:

* Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology.
* The sample size estimate: 20 cases per arm.
* Males or females aged ≥18 years, \< 75 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.
* Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
* Adequate bone marrow, renal, and liver function are required.
* Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria:

* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
* Allergy to anti-EGFR antibody.
* Female subjects should not be pregnant or breast-feeding.
* Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin \< 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases.
* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Primary outcomes:
measure: PFS (Progression free survival)
timeFrame: 12 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 6 months
measure: Overall survival (OS)
timeFrame: 12 months
measure: Disease control rate (DCR)
timeFrame: 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Qiong Zhao
state: Zhejiang
city: Hangzhou
country: China
facility: The first affiliated hospital, Zhejiang University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital,Zhejiang University
name: Qiong Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: