Clinical trial NCT02611700: Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma
Official title: An Prospective, Multicenter, Double-blind, Randomized, Controlled Clinical Study of Nimotuzumab Combined With Paclitaxel and Cisplatin as First-line Treatment of Metastatic Esophageal Squamous Cell Carcinomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinomas
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel+cisplatin（TP) compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.

Detailed description: This clinical study is designed as a phase 3,multicenter, double-blind, randomized, controlled study,to evaluate the efficacy and safety of nimotuzumab combined with TP compared with TP as first-line treatment for the metastatic esophageal squamous carcinoma.The main endpoint is OS.

Eligibility criteria: Inclusion Criteria:

1. Voluntary and sign a consent form;
2. Age≥18 years;
3. Histological diagnosis as metastatic esophageal squamous cell carcinoma, including: (1)Naked metastatic esophageal cancer：have no opportunity to receive any radical surgery or radical radiation therapy (2) recurrent metastatic esophageal cancer：recurrence after surgery or adjuvant radiotherapy or radical concurrent radio or radiochemotherapy,haven't received systemic chemotherapy and have measurable lesions outside radiotherapy target zone(3) recurrent metastatic esophageal cancer,more than 6 months after neoadjuvant or adjuvant chemotherapy;
4. When patients need to receive palliative radiotherapy,the palliative radiotherapy should complete over 4 weeks and target lesions should outside the radiotherapy target zone(radiotherapy lesions include but not limited to primary tumors, bone, lymph nodes);
5. According to RECIST 1.1 criteria, at least one measurable lesion exist;
6. Expected survival time is over 3 months;
7. Eastern Cooperative Oncology Group（ECOG）0 or 1;
8. Normal bone marrow and hematopoietic function;total bilirubin acuities≤1.5×Upper Limit Of Normal（ULN）, creatinine≤1.0×ULN, aspartate aminotransferase（AST）/alanine aminotransferase（ALT）≤2.5×ULN, ALP≤5.0×ULN, creatinine clearance \> 60 ml/min, liver metastases patients: AST/ALT≤5.0×ULN;
9. Take effective contraceptive measures when in growth period;
10. Compliance is good.

Exclusion Criteria:

1. Have received any palliative chemotherapy for metastatic esophageal cancer
2. Recurrence or metastasis after neoadjuvant chemotherapy or postoperative adjuvant \< 6 months;
3. Received any kinds of radiotherapy within 4 weeks;
4. Patients who can received palliative radiotherapy and all lesions are in one radiation zone;
5. Had received adjuvant/neoadjuvant therapy and have used paclitaxel within 6 months;
6. Had received adjuvant/neoadjuvant therapy and the cumulative dose of cisplatin was over 300 mg/m2;
7. Alone or combined with brain metastasis;
8. No measurable tumor lesions;
9. Combined with other primary malignant tumors (except cured skin basal cell carcinoma and cervical carcinoma in situ);
10. Allergy to the component of investigational drugs;
11. Patients who are receiving the treatment of chronic or multiple doses of corticosteroids (inhaled steroids or short-term oral cortisol according to the clinical indications were allowed);
12. Haven't recovered to degree 1 from the toxicity of treatment before.
13. Concomitant with severe cardiovascular diseases, such as uncontrol heart failure, coronary heart disease, cardiomyopathy, arrhythmia,high blood pressure or history of myocardial infarction within 5 years;
14. Concomitant with serious complications, such as the activity of the digestive tract hemorrhage, perforation, severe jaundice, gastrointestinal obstruction, active clinical infection (\> 2 levels of infection standard);
15. With chronic diarrhea disease and renal insufficiency;
16. Have disease affecting cognition or mental abnormal;
17. Have other severe acute or chronic diseases;
18. Pregnancy or lactation women;
19. Have participated in other clinical trials within 30 days.

Primary outcomes:
measure: Median time of overall survival(OS)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Median time of progression-free survival（PFS）
timeFrame: Up to 12 months
measure: Objective response rate（ORR）
timeFrame: Up to 12 months
measure: Quality of life
timeFrame: baseline;once every 6 weeks until progression(6 weeks,12 weeks,18 weeks,up to 52 weeks)
measure: Incidence of adverse events
timeFrame: Up to 30 days after last administration of nimotuzumab
Other outcomes:
Locations:
city: Hefei
country: China
facility: AnHui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital Medical School of Chinese PLA
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: The 307 Hospital of Chinese People's Liberation Army
state: Beijing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou city
country: China
facility: Sun Yat-Sen University Cancer Center Sun Yat-Sen University Cancer Hospital
state: Guangdong
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: HuNan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: JiangSu Province Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital ,JiangNan University
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: LiaoNing Cancer Hospital
state: Liaoning
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School Of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan hospital of fudan university
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated of Xi'an Communication University
state: Shanxi
city: Xi'an
country: China
facility: XiJing Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital,SiChuan University
state: Sichuan
city: TianJin
country: China
facility: TianJin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hostpital School of Medicine,Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The second Affiliated hospital of Zhejiang University School o
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Lin Shen, Dr
role: STUDY_CHAIR
References: