Clinical trial · Interventional
Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
A Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
NCT02375581CI-TRIAL-00021453unknownPhase 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)
To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib | Drug | Icotinib | ALIAS |
| Thoracic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Icotinib & Radiotherapy
- description
- Icotinib, 125mg, Po, Tid, during the course of radiotherapy; Thoracic radiotherapy, 50-60Gy, conventional fraction, 3D-CRT/IMRT.
- interventionNames
- Drug: Icotinib
- Radiation: Thoracic radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy alone
- description
- Thoracic radiotherapy alone, 50-60Gy, conventional fraction, 3D-CRT/IMRT.
- interventionNames
- Radiation: Thoracic radiotherapy
Primary outcomes (1)
- measure
- all cause mortality
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed esophageal carcinoma 2. Stage I~Iva By EUS and CT/MRI, without contraindication for radical radiotherapy 3. Aged ≥ 70 and \< 85 years, behavioral status evaluation ECOG scores 0-2 4. In 7 days after being screened, subjects should follow the status: WBC ≥ 3.0 x 10\^9/L; ANC ≥ 1.5x 10\^9/L; PLT ≥ 80 x 10\^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN 5. Subjects should sign for the informed consent 6. Subjects should perform good compliance Exclusion Criteria: 1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy 2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation 3. Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years 4. Patients who have multiple foci esophageal carcinomas 5. Patients who are/were given any other medicine tests currently/in last 4 weeks 6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines 7. Patients who have complications as following: (1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness.
References
Publications (1)
- DERIVEDLuo H, Jiang W, Ma L, Chen P, Fang M, Ding L, Hua Y, Du D, Jing Z, Xie R, Song Y, Wang J, Zhou R, Tian Z, Wu S. Icotinib With Concurrent Radiotherapy vs Radiotherapy Alone in Older Adults With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019440. doi: 10.1001/jamanetworkopen.2020.19440. PMID 33026449