EsophagealPhase 2NCT02749526
Endostar Combined With MPFC Adjuvant Treatment of Esophageal Cancer Clinical Trial
A Phase 2 study testing "Endostar", Liposo and cisplatin in people with Esophageal, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal
- What is being tested?
- "Endostar", Liposo and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to 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 with esophageal cancer confirmed by histology or cytology;
- according to TNM staging for Ⅲ period, previous untreated can be removed and potentially resectable esophageal cancer patients;
- can eat more than liquid diet;No signs before esophageal perforation;No distant metastasis;
- male or female, age 18 and 75 years old or less or more;
- ECOG PS 0 ~ 1 minute;
- is expected to survive period for 3 months or more,
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- enough blood function: absolute neutrophil count (ANC) or 2 x 109 / L and the • platelet count 100 x 109 / L or higher acuity 9 g/dL and hemoglobin;Liver function
- enough: upper limit of total bilirubin acuities were normal (ULN);AST and ALT acuities were 2.5 times the upper limit of normal (ULN);Alkaline phosphatase 5 times the upper limit of normal or less (ULN);
- enough renal function, serum creatinine or less normal limit (ULN) or calculated creatinine clearance or 60 mL/min.
- basic normal ecg, no healing trauma;
- always not received anti-tumor drug treatment;
- ever had had surgery patients, request to study treatment began to have more than 4 weeks, and the patient has recovered;
- a complete uterus of female in the group within 28 days before the study must have a negative pregnancy test results (except amenorrhea has 24 months).If the pregnancy test from the first time for more than 7 days, is the need for urine pregnancy test validation (within 7 days before the first delivery).
- prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;
Who cannot join
- there is a clear taxol allergy history;
- pregnancy, nursing mothers, or have fertility but not women using contraception;
- the existing serious acute infection, and not be controlled;Or fester sex and chronic infection, wound in delay no more;
- the original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
- is not easy to control nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment;Primary brain tumors or CNS metastases illness did not get a control, has obvious symptoms in cranial hypertension or nerve spirit;
- with bleeding tendency;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial.
Read the detailed description
- Research purpose: Endostar (recombinant human endostatin) continuous intravenous infusion combined with chemotherapy for stage Ⅲ resectable or potentially resectable esophageal cancer efficacy and safety and to maintain the efficacy and safety.
- The main objectives: R0 resection rate
Secondary objectives:
- pCR rate
- 3-year disease-free survival
- Security and complications
- DFS, OS
- Quality of Life
3.The number of research centers and research time: This study intends to preside and implemented by the Jiangsu Provincial People's Hospital, Professor Gu Yanhong. The trial is scheduled to start in September 2015, planned to stop in June 2016 into the group, one patient surgery follow-up to the last end, get the primary endpoint and safety, surgical complications secondary endpoint. This study will continue to follow-up the patient DFS, OS and other secondary end points.
- Conditions
- Esophageal
- Being tested
- "Endostar", Liposo, cisplatin, Gimeracil and Oteracil Potassium （Tegafur）
- Keywords
- Recombinant human endostatin，Endo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Endostar"Drug
30mg civ24h d0-6.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
LiposoDrug
135mg/m2 D1.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
cisplatinDrug
25mg/m2 D1-3.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
Gimeracil and Oteracil Potassium （Tegafur）Drug
40mg bid，D1-14.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
| Study group | Role | What they receive |
|---|---|---|
| Endostar combined with MPFC | Experimental | Chemotherapy regimens (er degree + mPFC) :
Endostar:
degrees 30 mg civ24h d0-6;
Liposo:
135 mg/m2 D1; cisplatin: D1-3, 25 mg/m2
Gimeracil and Oteracil Potassium (Tegafur):
(40 mg bid Tegafur), D1-14. A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy. Receives: Drug: "Endostar"; Drug: Liposo; Drug: cisplatin; Drug: Gimeracil and Oteracil Potassium （Tegafur） |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 Resection rate
Measured: up to 8 months
Secondary outcomes (1)
pCR rate
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagealStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gu Yanhong, PI, Study chair, China:Jiangsu people's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749526
- Sponsor's protocol ID
- JS-ENDO-003
- Status last verified
- Jul 2022
- First submitted
- 28 Mar 2016
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endostar Combined With MPFC Adjuvant Treatment of Esophageal Cancer Clinical Trial
- ClinicalTrials.gov ID
- NCT02749526
- Acronym / sponsor ID
- JS-ENDO-003
- Conditions
- Esophageal
- Keywords
- Recombinant human endostatin，Endo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual rate
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Apr 2016 (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.
Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial.
Detailed description
- Research purpose: Endostar (recombinant human endostatin) continuous intravenous infusion combined with chemotherapy for stage Ⅲ resectable or potentially resectable esophageal cancer efficacy and safety and to maintain the efficacy and safety.
- The main objectives: R0 resection rate
Secondary objectives:
- pCR rate
- 3-year disease-free survival
- Security and complications
- DFS, OS
- Quality of Life
3.The number of research centers and research time: This study intends to preside and implemented by the Jiangsu Provincial People's Hospital, Professor Gu Yanhong. The trial is scheduled to start in September 2015, planned to stop in June 2016 into the group, one patient surgery follow-up to the last end, get the primary endpoint and safety, surgical complications secondary endpoint. This study will continue to follow-up the patient DFS, OS and other secondary end points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endostar combined with MPFC | Experimental | Drug: "Endostar", Drug: Liposo, Drug: cisplatin, Drug: Gimeracil and Oteracil Potassium （Tegafur）Chemotherapy regimens (er degree + mPFC) : Endostar: degrees 30 mg civ24h d0-6; Liposo: 135 mg/m2 D1; cisplatin: D1-3, 25 mg/m2 Gimeracil and Oteracil Potassium (Tegafur): (40 mg bid Tegafur), D1-14. A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- patients with esophageal cancer confirmed by histology or cytology;
- according to TNM staging for Ⅲ period, previous untreated can be removed and potentially resectable esophageal cancer patients;
- can eat more than liquid diet;No signs before esophageal perforation;No distant metastasis;
- male or female, age 18 and 75 years old or less or more;
- ECOG PS 0 ~ 1 minute;
Key exclusion criteria (6 listed)
- there is a clear taxol allergy history;
- pregnancy, nursing mothers, or have fertility but not women using contraception;
- the existing serious acute infection, and not be controlled;Or fester sex and chronic infection, wound in delay no more;
- the original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension;
- is not easy to control nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment;Primary brain tumors or CNS metastases illness did not get a control, has obvious symptoms in cranial hypertension or nerve spirit;
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 |
|---|---|---|
| "Endostar"30mg civ24h d0-6.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy. | Drug | Endostar combined with MPFC |
| Liposo135mg/m2 D1.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy. | Drug | Endostar combined with MPFC |
| cisplatin25mg/m2 D1-3.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy. | Drug | Endostar combined with MPFC |
| Gimeracil and Oteracil Potassium （Tegafur）40mg bid，D1-14.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy. | Drug | Endostar combined with MPFC |
Primary outcome
R0 Resection rate
Time frame: up to 8 months
1 secondary outcome
pCR rate
Time frame: up to 10 months
Results and safety
The study was stopped early (reason given: low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Gu Yanhong, PI study chair
China:Jiangsu people's hospital
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 "Endostar", Liposo and cisplatin in people with Esophageal, run by The First Affiliated Hospital with Nanjing Medical University 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 14 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Jul 2022. 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 was stopped early (reason given: low accrual rate). Results are not available in the source record.
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?
R0 Resection rate (time frame: up to 8 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 29 Jul 2022.