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

NCT01973725 | Completed Phase 2 DMC

• 1 other identifier: ICO-29
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  Disease control rate of tumor

  for up to 6 months

Secondary Outcomes (4)

• Overall survival

  Time from day 1 to date of death

• Time to progression

  Time from day 1 to date of documented disease progression

• Adverse event

  Each follow up vist, assessed up to 12 months

• EORTC QLQ-C30 and QLQ-OES18

  Time from day 1 to date of death

Study Arms (1)

Icotinib Hydrochloride

EXPERIMENTAL

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

Drug: Icotinib Hydrochloride

Interventions

Icotinib Hydrochloride DRUG

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

Also known as: Conmana

Icotinib Hydrochloride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhong Li: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Li Yuhong, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: October 31, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)