NCT02611700
Unknown
Phase 3
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
ConditionsEsophageal Squamous Cell Carcinomas
Overview
- Phase
- Phase 3
- Intervention
- Nimotuzumab
- Conditions
- Esophageal Squamous Cell Carcinomas
- Sponsor
- Biotech Pharmaceutical Co., Ltd.
- Enrollment
- 504
- Locations
- 27
- Primary Endpoint
- Median time of overall survival(OS)
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntary and sign a consent form;
- •Age≥18 years;
- •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;
- •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);
- •According to RECIST 1.1 criteria, at least one measurable lesion exist;
- •Expected survival time is over 3 months;
- •Eastern Cooperative Oncology Group（ECOG）0 or 1;
- •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;
- •Take effective contraceptive measures when in growth period;
- •Compliance is good.
Exclusion Criteria
- •Have received any palliative chemotherapy for metastatic esophageal cancer
- •Recurrence or metastasis after neoadjuvant chemotherapy or postoperative adjuvant \< 6 months;
- •Received any kinds of radiotherapy within 4 weeks;
- •Patients who can received palliative radiotherapy and all lesions are in one radiation zone;
- •Had received adjuvant/neoadjuvant therapy and have used paclitaxel within 6 months;
- •Had received adjuvant/neoadjuvant therapy and the cumulative dose of cisplatin was over 300 mg/m2;
- •Alone or combined with brain metastasis;
- •No measurable tumor lesions;
- •Combined with other primary malignant tumors (except cured skin basal cell carcinoma and cervical carcinoma in situ);
- •Allergy to the component of investigational drugs;
Arms & Interventions
experimental group
Nimotuzumab+TP(paclitaxel+cisplatin)
Intervention: Nimotuzumab
experimental group
Nimotuzumab+TP(paclitaxel+cisplatin)
Intervention: Paclitaxel
experimental group
Nimotuzumab+TP(paclitaxel+cisplatin)
Intervention: Cisplatin
control group
Placebo + TP(paclitaxel+cisplatin)
Intervention: Paclitaxel
control group
Placebo + TP(paclitaxel+cisplatin)
Intervention: Cisplatin
control group
Placebo + TP(paclitaxel+cisplatin)
Intervention: Placebo
Outcomes
Primary Outcomes
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 Outcomes
- Objective response rate（ORR）(Up to 12 months)
- Quality of life(baseline;once every 6 weeks until progression(6 weeks,12 weeks,18 weeks,up to 52 weeks))
- Median time of progression-free survival（PFS）(Up to 12 months)
- Incidence of adverse events(Up to 30 days after last administration of nimotuzumab)
Study Sites (27)
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