Clinical trial · Interventional
Nimotuzumab Plus Nab-paclitaxel and Cisplatin in Treating Patients With Advanced Esophageal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No recruitment
Summary
Brief summary (as posted)
There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy.And,albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,and with greater concentration in tumor tissue compared with normal tissues.So,The objective of this single-arm phase II trial was to evaluate the benefit of nimotuzumab plus nab-paclitaxel and cisplatin in patients with advanced esophageal 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 |
|---|---|---|---|
| Stage IV Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab & nab-paclitaxel & cisplatin
- description
- Nimotuzumab: 200mg,IV once a week during chemotherapy. Nab-paclitaxel: 125mg/m2,(IV over 30 min) (days 1 and 8) on 21 day cycle Cisplatin: 75mg/m2,IV on 21 day cycle
- interventionNames
- Drug: Nimotuzumab
Primary outcomes (1)
- measure
- Progression free survival(PFS)
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- From date of treatment until the date of progression, assessed up to 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology. * Males or females aged ≥18 years, \< 75 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Life expectancy ≥12 weeks. * Adequate bone marrow, renal, and liver function are required. * Able to comply with the required protocol and follow-up procedures, and able to receive oral medications. Exclusion Criteria: * Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * Allergy to anti-EGFR antibody. * Female subjects should not be pregnant or breast-feeding. * Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin \< 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases. * Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
References
Publications (0)
Data not yet available