Esophageal Squamous Cell CarcinomaPhase 2NCT01973725
Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Cancer After Failure of Conventional Chemotherapy
A Phase 2 study testing Icotinib Hydrochloride in people with Esophageal Squamous Cell Carcinoma, run by Yuhong Li at 1 site in China.
Trial summary
Phase II Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Icotinib Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Icotinib Hydrochloride
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icotinib HydrochlorideDrug
Also called Conmana
Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Icotinib Hydrochloride | Experimental | Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days. Receives: Drug: Icotinib Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
Disease control rate of tumor
Measured: for up to 6 months
Secondary outcomes (4)
Overall survival
From time of diagnosis to death or lost to follow-up
Measured: Time from day 1 to date of death
Time to progression
From time of diagnosis to disease progression
Measured: 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
Measured: 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
Measured: Time from day 1 to date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuhong Li, Sun Yat-sen University
- Investigators
- Li Yuhong, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973725
- Sponsor's protocol ID
- ICO-29
- Status last verified
- Feb 2023
- First submitted
- 25 Oct 2013
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseⅡ Study of Icotinib Hydrochloride in Treating Patients With Recurrent or Metastatic Esophageal Squamous Carcinoma After Failure of Conventional Chemotherapy
- ClinicalTrials.gov ID
- NCT01973725
- Acronym / sponsor ID
- ICO-29
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yuhong LiUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icotinib Hydrochloride | Experimental | Drug: Icotinib HydrochloridePatients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Icotinib HydrochlorideAlso: ConmanaPatients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days. | Drug | Icotinib Hydrochloride |
Primary outcome
Disease control rate
Time frame: for up to 6 months
Disease control rate of tumor
4 secondary outcomes
Overall survival
Time frame: Time from day 1 to date of death
Time to progression
Time frame: Time from day 1 to date of documented disease progression
Adverse event
Time frame: Each follow up vist, assessed up to 12 months
EORTC QLQ-C30 and QLQ-OES18
Time frame: Time from day 1 to date of death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Yuhong, MD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Icotinib Hydrochloride in people with Esophageal Squamous Cell Carcinoma, run by Yuhong Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (time frame: for up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.