Clinical trial · Interventional
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Clinical Trial
Nimotuzumab Combined With Radiotherapy for Older Patients With Esophageal Cancer: a Single, Non-control Phase II Clinical Trial
- 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)
For patients who are unable to receive surgery or having local advanced esophageal cancer stages, concurrent chemoradiotherapy is recommended. But radiotherapy is the main strategy for older patients because of their chemoradiotherapy intolerance. The whole world focused on targeted therapy which has strong specialties and mild toxicities. So combined targeted therapy and radiotherapy may be a novel strategy for older patients with esophageal cancer. Nimotuzumab is a EGFR monoclonal antibody. This clinical trial is to study the effect and safety of Nimotuzumab in combined with radiotherapy for older patients with esophageal cancer. All patients receive intensity modulated radiotherapy with conventional fraction. Nimotuzumab with 200mg is given weekly for all patients during radiotherapy.
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- radiotherapy
- description
- It is just a single group assignment
- interventionNames
- Drug: Nimotuzumab
Primary outcomes (1)
- measure
- Safety of Nimotuzumab combined with Radiotherapy for older patients
- timeFrame
- 2 years
- description
- To observe the adverse events during the treatment
Secondary outcomes (1)
- measure
- Efficacy of Nimotuzumab combined with Radiotherapy for older esophageal cancer patients
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients aged 70 years or older; 2. treatment naive patients with histologically proven thoracic-segment EC that was inoperable and who could not tolerate CCRT; 3. stage II-IV disease (supraclavicular lymph node metastasis only), according to the 6th American Joint Committee on Cancer TNM staging system; 4. estimated survival time ≥3 months; 5. Karnofsky performance score ≥70; 6. adequate bone marrow, as well as hepatic and renal function; 7. voluntary written consent provided prior to treatment. Exclusion Criteria: 1. esophagobronchial or esophagomediastinal fistula; 2. patients who had joined other clinical trials prior to this treatment; 3. serious heart, liver, and/or kidney insufficiency; 4. serious infectious disease; 5. relapse disease or distant metastasis; 6. recently diagnosed neoplastic diseases; 7. previous receipt of surgery, chemotherapy, or radiotherapy for EC.
References
Publications (0)
Data not yet available