Clinical trial · Interventional
Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy
PhaseⅡ Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy
NCT01973725CI-TRIAL-00064047completedPhase 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)
Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.
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 Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Icotinib Hydrochloride | Drug | Icotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Icotinib Hydrochloride
- description
- Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
- interventionNames
- Drug: Icotinib Hydrochloride
Primary outcomes (1)
- measure
- Disease control rate
- timeFrame
- for up to 6 months
- description
- Disease control rate of tumor
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
- Time from day 1 to date of death
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients have provided a signed Informed Consent Form * Age: 18-75 years old * Histologically confirmed diagnosis of esophageal squamous cell carcinoma * Patients have Received and progressed on 1 line of prior Fluoropyrimidine, platinum or taxane based palliative chemotherapy * Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria * Life expectancy ≥ 3 months * Karnofsky score ≥70 * Patient has adequate bone marrow and organ function * Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L * Platelets ≥ 75 x 109/L * Hemoglobin ≥ 9.0 g/dL * Patient has adequate liver function * AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis) * Serum bilirubin ≤ 2 x ULN * Creatinine ≤ 1.5 times ULN * No malabsorption or other gastrointestinal disorders affecting drug absorption. * No serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever \> 38 ℃. * Expect good compliance Exclusion Criteria: * Patient has received previous treatment with EGFR inhibitors * Patient is currently receiving Phenytoin, rifampin, barbiturates, C Masi Bing * Known severe hypersensitivity to Icotinib or any of the excipients of this product * CNS metastases without radiotherapy and/or surgery * Patients with treated CNS metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for CNS metastases is less than 4 weeks * Evidence of clinically active Interstitial Lung Diseases * Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases * Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ * psychiatric illness that would prevent the patient from giving informed consent * Patient is concurrently using other approved or investigational antineoplastic agent * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.