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

Phase 2

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Icotinib Hydrochloride

• Registration Number: NCT01973725
• Lead Sponsor: Yuhong Li

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Primary Completion: 2018-09
• Study Completion: 2018-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Disease control rate	for up to 6 months	Disease control rate of tumor

Secondary Outcome Measures

Name	Time	Method
Overall survival	Time from day 1 to date of death	From time of diagnosis to death or lost to follow-up
EORTC QLQ-C30 and QLQ-OES18	Time from day 1 to date of death	Quality of life will be assessed at each study visit using EORTC QLQ-C30 and QLQ-OES18
Time to progression	Time from day 1 to date of documented disease progression	From time of diagnosis to disease progression
Adverse event	Each follow up vist, assessed up to 12 months	Safety data will be assessed at each study visit using NCI CTCAE version 3.0

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China