Clinical trial · Interventional
Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer
The Phase II of Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer
NCT02591784CI-TRIAL-00057179completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.
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 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab group
- description
- Nimotuzumab+radiotherapy
- interventionNames
- Drug: Nimotuzumab
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)
- timeFrame
- 3 months
- description
- assement of advers event after using medication based TAAE evaluation form
Secondary outcomes (6)
- measure
- Complete response
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis. 2. with the measureable lesion of the newly diagnosed the esophageal carcinoma. 3. age 18-75 years old 4. ECOG≤2 5. Expect survival date ≥3 months 6. without serious diseases of important organs 7. signature in the inform consent. Exclusion Criteria: 1. pregnant or breast-feeding women or using a prohibited contraceptive method. 2. with psychiatric diseases. 3. with serious diseases or uncontrolled infection. 4. with history of other tumors. 5. participation other clinical trials within 1 month prior to inclusion in the trial. 6. not the first antitumor treatment .
References
Publications (0)
Data not yet available
No reference posted for this study.