Clinical trial · Interventional
Nimotuzumab in Combined With Paclitaxel and Cisplatin for Treatment of Metastatic Esophageal Squamous Cell Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinomas | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Nimotuzumab+TP(paclitaxel+cisplatin)
- interventionNames
- Drug: Nimotuzumab
- Drug: Paclitaxel
- Drug: Cisplatin
- type
- PLACEBO_COMPARATOR
- label
- control group
- description
- Placebo + TP(paclitaxel+cisplatin)
- interventionNames
- Drug: Paclitaxel
- Drug: Cisplatin
- Drug: Placebo
Primary outcomes (1)
- measure
- Median time of overall survival(OS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available