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

B

Biotech Pharmaceutical

Status and phase

Unknown
Phase 3

Conditions

Esophageal Squamous Cell Carcinomas

Treatments

Drug: Cisplatin
Drug: Paclitaxel
Drug: Placebo
Drug: Nimotuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT02611700
BPL-IST-ESO-057

Details and patient eligibility

About

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.

Full 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.

Enrollment

504 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

504 participants in 2 patient groups, including a placebo group

experimental group
Experimental group
Description:
Nimotuzumab+TP(paclitaxel+cisplatin)
Treatment:
Drug: Paclitaxel
Drug: Nimotuzumab
Drug: Cisplatin
control group
Placebo Comparator group
Description:
Placebo + TP(paclitaxel+cisplatin)
Treatment:
Drug: Placebo
Drug: Paclitaxel
Drug: Cisplatin

Trial contacts and locations

27

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Central trial contact

Lin Shen, Dr; Jun Zhou

Data sourced from clinicaltrials.gov

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