Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhong Li

Criteria

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