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

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ClinicalTrials.gov Identifier: NCT02611700
Recruitment Status : Unknown
Verified January 2016 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : November 23, 2015
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Biotech Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinomas Drug: Nimotuzumab Drug: Paclitaxel Drug: Cisplatin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: experimental group
Nimotuzumab+TP(paclitaxel+cisplatin)
Drug: Nimotuzumab
400mg,day1,weekly,until disease progression or toxicity

Drug: 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.
Other Name: Paclitaxel Injection

Drug: Cisplatin
60mg/m^2,day1,21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
Other Name: Cisplatin for Injection

Placebo Comparator: control group
Placebo + TP(paclitaxel+cisplatin)
Drug: 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.
Other Name: Paclitaxel Injection

Drug: Cisplatin
60mg/m^2,day1,21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
Other Name: Cisplatin for Injection

Drug: Placebo
400mg,day1,weekly,until disease progression or toxicity
Other Name: Nimotuzumab Placebo




Primary Outcome Measures :
  1. Median time of overall survival(OS) [ Time Frame: Up to 12 months ]
    Record all the survival status of each patient and calculate the median OS of all the patients


Secondary Outcome Measures :
  1. Median time of progression-free survival(PFS) [ Time Frame: Up to 12 months ]
    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.

  2. Objective response rate(ORR) [ Time Frame: Up to 12 months ]
    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)%.

  3. Quality of life [ Time Frame: baseline;once every 6 weeks until progression(6 weeks,12 weeks,18 weeks,up to 52 weeks) ]
    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.

  4. Incidence of adverse events [ Time Frame: Up to 30 days after last administration of nimotuzumab ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611700


Contacts
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Contact: Lin Shen, Dr 13911219511 lin100@medmail.com.cn
Contact: Jun Zhou 13366152815 13366152815@126.com

  Show 27 Study Locations
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
Investigators
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Study Chair: Lin Shen, Dr Beijing Cancer Hospital

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Responsible Party: Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02611700     History of Changes
Other Study ID Numbers: BPL-IST-ESO-057
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Nimotuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological