Esophagus Cancer, Stage IIIPhase 2/3NCT03285906
An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric
A Phase 2/3 study testing Apatinib in people with Esophagus Cancer, Stage III and Esophageal Gastric Cardia Type Metaplasia, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal cancer or esophageal and gastric Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophagus Cancer, Stage III, Esophageal Gastric Cardia Type Metaplasia, Esophagus Cancer, Stage IV
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to Dec 2019
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 and ≤ 75 years of age
- Have failed for 1 lines of chemotherapy
- ECOG performance scale 0 - 2.
- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min.
- Life expectancy of more than 12 months
Who cannot join
- Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- Any factors that influence the usage of oral administration
- The center of the tumor invaded local large blood vessels
- Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
- Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
- Less than 4 weeks from the last clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Pan Zhanyu, Master, 86-13752570372, liyanwei127@hotmail.com
About this study
The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal cancer or esophageal and gastric
Read the detailed description
This study is a prospective,single-center,single arm,Ⅱ exploratory study.To explore the clinical study of the efficacy and safety of the treatment of vegfr-2 high expression by apatinib mesilate.The main research object for first-line treatment failure Ⅲ/Ⅳ integration of a period of esophageal or gastric esophagus cancer patients.The main purpose of the study was to evaluate apatinib for the median PFS of the esophageal and esophageal gastric junction carcinoma of the esophagus with high expression of VEGFR-2. The objective of secondary research is to evaluate the safety of apatinib for second-line treatment of esophageal and esophageal gastric junction cancer Objective Response Rate (CR + PR) and median OS and explore the relationship between VEGFR-2 high expression and apatinib efficacy and related prognostic factors. Thirty patients were enrolled in the study group. The group was expected to be enrolled in the group for 24 months, followed by 6 months of follow-up and 6 months of data statistics. The drug regimen was a single drug apatinib 500mg qd Po.Please refer to the CRF table for details.
- Conditions
- Esophagus Cancer, Stage III, Esophageal Gastric Cardia Type Metaplasia, Esophagus Cancer, Stage IV
- Being tested
- Apatinib
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called YN968D1
Targeted therapy Apatinib：500 mg，po，qd
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Apatinib：500 mg，po，qd Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
No progress in survival (PFS) is to use the RECIST 1.1 standard to assess the progress of the evaluation of the population without progress.The date of the first occurrence of a disease or any cause of death from a random date to the first occurrence.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Objective Response Rate
Objective Response Rate(ORR):The proportion of patients who have been reduced to a certain amount and maintained a certain amount of time, including the CR + PR case.
Measured: Through study completion, an average of 0.5 year
median Overall Survival
median Overall Survival (mOS):It means that 50% of patients start from randomization to the time of death for any reason.
Measured: Through study completion, an average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start1 Mar 2017
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus Cancer, Stage IIIStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pan Zhanyu, Master, Principal investigator, 86-13752570372
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285906
- Sponsor's protocol ID
- AHEAD-HBE001
- Status last verified
- Jul 2017
- First submitted
- 21 Aug 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: PFS data of patients in this trial are expected to be Shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Apatinib for the 2nd Treatment of Esophageal Cancer or Esophageal and Gastric
- ClinicalTrials.gov ID
- NCT03285906
- Acronym / sponsor ID
- AHEAD-HBE001
- Conditions
- Esophagus Cancer, Stage III, Esophageal Gastric Cardia Type Metaplasia, Esophagus Cancer, Stage IV
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Sep 2017 (actual)
- 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.
The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）for the second - line treatment of esophageal cancer or esophageal and gastric
Detailed description
This study is a prospective,single-center,single arm,Ⅱ exploratory study.To explore the clinical study of the efficacy and safety of the treatment of vegfr-2 high expression by apatinib mesilate.The main research object for first-line treatment failure Ⅲ/Ⅳ integration of a period of esophageal or gastric esophagus cancer patients.The main purpose of the study was to evaluate apatinib for the median PFS of the esophageal and esophageal gastric junction carcinoma of the esophagus with high expression of VEGFR-2. The objective of secondary research is to evaluate the safety of apatinib for second-line treatment of esophageal and esophageal gastric junction cancer Objective Response Rate (CR + PR) and median OS and explore the relationship between VEGFR-2 high expression and apatinib efficacy and related prognostic factors. Thirty patients were enrolled in the study group. The group was expected to be enrolled in the group for 24 months, followed by 6 months of follow-up and 6 months of data statistics. The drug regimen was a single drug apatinib 500mg qd Po.Please refer to the CRF table for details.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: ApatinibApatinib：500 mg，po，qd |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 and ≤ 75 years of age
- Have failed for 1 lines of chemotherapy
- ECOG performance scale 0 - 2.
- Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min.
- Life expectancy of more than 12 months
Key exclusion criteria (7 listed)
- Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
- Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
- Any factors that influence the usage of oral administration
- The center of the tumor invaded local large blood vessels
- Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
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 |
|---|---|---|
| ApatinibAlso: YN968D1Targeted therapy Apatinib：500 mg，po，qd | Drug | Treatment group |
Primary outcome
progression-free survival
Time frame: Through study completion, an average of 1 year
No progress in survival (PFS) is to use the RECIST 1.1 standard to assess the progress of the evaluation of the population without progress.The date of the first occurrence of a disease or any cause of death from a random date to the first occurrence.
2 secondary outcomes
Objective Response Rate
Time frame: Through study completion, an average of 0.5 year
median Overall Survival
Time frame: Through study completion, an average of 1.5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: Undecided. PFS data of patients in this trial are expected to be Shared
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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.
Pan Zhanyu, Master principal investigator
86-13752570372
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Apatinib in people with Esophagus Cancer, Stage III and Esophageal Gastric Cardia Type Metaplasia, run by Tianjin Medical University Cancer Institute and Hospital 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 Sep 2017. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pan Zhanyu, Master (86-13752570372, liyanwei127@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: Through study completion, an average of 1 year). 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 18 Sep 2017.