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

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

Study Overview

• Status: Completed
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Icotinib Hydrochloride

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icotinib Hydrochloride; Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.	Drug: Icotinib Hydrochloride; Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.; Other Names: Conmana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate	Disease control rate of tumor	for up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuhong Li
• Investigators: Principal Investigator: Li Yuhong, MD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 25, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Neoplasms; Carcinoma; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: ICO-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES