Clinical trial NCT02591784: Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer
Official title: The Phase II of Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal
Keywords: nimotuzumab esophageal radiotherapy
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Detailed description: Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Eligibility criteria: Inclusion Criteria:

1. pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis.
2. with the measureable lesion of the newly diagnosed the esophageal carcinoma.
3. age 18-75 years old
4. ECOG≤2
5. Expect survival date ≥3 months
6. without serious diseases of important organs
7. signature in the inform consent.

Exclusion Criteria:

1. pregnant or breast-feeding women or using a prohibited contraceptive method.
2. with psychiatric diseases.
3. with serious diseases or uncontrolled infection.
4. with history of other tumors.
5. participation other clinical trials within 1 month prior to inclusion in the trial.
6. not the first antitumor treatment .

Primary outcomes:
measure: The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)
timeFrame: 3 months
Secondary outcomes:
measure: Complete response
timeFrame: 3 months
measure: Partial response (PR)
timeFrame: 3 months
measure: Stable disease (SD)
timeFrame: 3 months
measure: Progressive disease (PD)
timeFrame: 3 months
measure: Median survival time (MST)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 1 year,2 years
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Affiliated tumour hosiptal of HARBIN Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Jinan
country: China
facility: Qilu Hospital,Shandong University
state: Shandong
city: Beijing
country: China
facility: Cancer Institute & Hospital, Chinese Academy of Medical Sciences
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Lvhua Wang
role: PRINCIPAL_INVESTIGATOR
References: