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

NCT ID: NCT01973725

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-12-31

Brief Summary

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

Detailed Description

Currently,there is no standard second-line therapy for esophageal squamous cell carcinoma.More effective therapy for patients with this disease who developed disease progression after first line therapy is needed.Although Erlotinib is recommended in NCCN Guideline Version 2.2013,there is still insufficient evidence on EGFR-TKI as second-line therapy for esophageal squamous carcinoma.Therefore,further research is necessary.In this phase II study,we evaluate the efficacy and safety of Icotinib Hydrochloride as treatment for patients with recurrent or metastasis esophageal squamous carcinoma after failure of conventional chemotherapy,and analyse the value of biomarkers of these patient to identify who benefit.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Icotinib Hydrochloride

Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.

Group Type: EXPERIMENTAL

Icotinib Hydrochloride

Intervention Type: DRUG

Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.

Interventions

Icotinib Hydrochloride

Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.

Intervention Type: DRUG

Other Intervention Names

Conmana

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhong Li

OTHER

Sponsor Role: lead

Responsible Party

Yuhong Li

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Li Yuhong, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ICO-29

Identifier Type: -

Identifier Source: org_study_id