Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinomas Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02611700
• Other study ID #: BPL-IST-ESO-057
• Status: Recruiting
• Phase: Phase 3
• First received: November 12, 2015
• Last updated: January 29, 2016
• Start date: November 2015
• Est. completion date: June 2019

Study information

• Verified date: January 2016
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: Lin Shen, Dr
• Phone: 13911219511
• Email: lin100[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 504
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinomas

Intervention

Drug:
• Nimotuzumab
400mg,day1,weekly,until disease progression or toxicity
• Paclitaxel
175mg/m^2,for 3 hour(Peripherally Inserted Central Catheter,PICC),day1,21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
• Cisplatin
60mg/m^2,day1,21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
• Placebo
400mg,day1,weekly,until disease progression or toxicity

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Chinese PLA General Hospital Medical School of Chinese PLA	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The 307 Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	HuNan Cancer Hospital	Changsha	Hunan
China	West China Hospital,SiChuan University	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Sun Yat-Sen University Cancer Center Sun Yat-Sen University Cancer Hospital	Guangzhou city	Guangdong
China	Sir Run Run Shaw Hostpital School of Medicine,Zhejiang University	Hangzhou	Zhejiang
China	The second Affiliated hospital of Zhejiang University School o	Hangzhou	Zhejiang
China	Zhejiang cancer hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	AnHui Provincial Hospital	Hefei	Anhui
China	JiangSu Province Hospital	Nanjing	Jiangsu
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	Rui Jin Hospital Shanghai Jiao Tong University School Of Medicine	Shanghai	Shanghai
China	Zhongshan hospital of fudan university	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong
China	LiaoNing Cancer Hospital	Shenyang	Liaoning
China	TianJin Medical University Cancer Institute and Hospital	TianJin	Tianjin
China	Affiliated Hospital ,JiangNan University	Wuxi	Jiangsu
China	The First Affiliated of Xi'an Communication University	Xi'an	Shanxi
China	XiJing Hospital	Xi'an	Shanxi
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median time of overall survival(OS)	Record all the survival status of each patient and calculate the median OS of all the patients	Up to 12 months	No
Secondary	Median time of progression-free survival(PFS)	PFS is the time that passes from the date of signing Informed Consent Form(ICF)to the data on which "progresses" or the date on which the patient dies from any cause. The definition of "progression" since this generally involves imaging techniques(CT,MRI,et al).The Response Evaluation Criteria In Solid Tumors (RECISIT) 1.1 criteria will be used to evaluate "progression".The imaging evaluation will be done every 6 weeks.	Up to 12 months	No
Secondary	Objective response rate(ORR)	This wil be evaluated by RECISIT 1.1 criteria.It is dependent on imaging evaluation which will be done every 6 weeks. ORR is the percent of the patient who is evaluated as complete response(CR) or partial response (PR),that is (CR+PR)%.	Up to 12 months	No
Secondary	Quality of life	Using the European Organization for Research and Treatment of Cancer(EORTC)quality of life questionnaire(QLQ)-C30(Version3.0)and EORTC QLQ - OES18 to evaluate the quality of life of patients. The patients will fill this questionnaire when signing the ICF(as baseline) and every 6 weeks during treatment,until disease progression,up to 52 weeks. The progression is from date of randomization until the date of first documented progression or date of death from any cause.	baseline;once every 6 weeks until progression(6 weeks,12 weeks,18 weeks,up to 52 weeks)	No
Secondary	Incidence of adverse events		Up to 30 days after last administration of nimotuzumab	Yes