Esophageal Squamous Cell CarcinomaPhase 2NCT02665702
Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas
A Phase 2 study testing NVB, DDP and Endostar in people with Esophageal Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The aim of this study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens 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?
- NVB, DDP and Endostar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Sep 2019
- 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
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- According to the esophageal AJCC2009 7th to determine new stage IV esophageal cancer
- The subject has PD after first-line chemotherapy or radiation within a year
- Presence of at least one index lesion measurable by CT scan or MRI according to RECIST 1.1
- Can eat more than liquid diet; No signs before esophageal perforation
- 18~75 years
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- PS:0-1
- Life expectancy of ≥ 3 months
- ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
- TB ≤ UNL； ALT/AST ≤ 2.5×UNL，AKP ≤ 5×UNL
- Ccr≤ UNL,Scr≥60 mL/min
- Normal electrocardiogram (ecg), the body had no unheal wounds
- Radiotherapy before within the scope of the normal dose and not affect subsequent treatment
- Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions
- Signed written informed consent
Who cannot join
- Breast-feeding or pregnant women, no effective contraception if risk of conception exists
- Chronic diarrhea, enteritis, intestine obstruction which are not under control
- Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
- A second primary tumor (except skin basal cell carcinoma)
- 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
- With uncontrol 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 cranial hypertension or nerve mental symptoms
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- With bleeding tendency
- Has inherited bleeding evidence of physical or blood coagulation disorder
- With clear chemotherapy drug allergy
- Other researchers believe that patients should not participate in this testing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Chang jian hua, PD, 13916619284, changjianhua@163.com
About this study
Official title: Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study
The aim of this study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens
Read the detailed description
This study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens used as second-line treatment of advanced esophageal squamous cell carcinomas
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- NVB, DDP, Endostar
- 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.
NVBDrug
Also called Vinorelbine Injection
25mg/m2 ，D1，8
DDPDrug
Also called Cisplatin
75mg/m2 ，D1 or 25mg/m2 D1-3
EndostarDrug
Also called endo
15mg/d，d1-d7 civ
| Study group | Role | What they receive |
|---|---|---|
| Endostar Combined With NVB and DDP | Experimental | Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2 Receives: Drug: NVB; Drug: DDP; Drug: Endostar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: from the first cycle of treatment (day one) to two month after the last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
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.
- More trials run by Fudan 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Jian Hua, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665702
- Sponsor's protocol ID
- ENDO-SH-001
- Status last verified
- Jan 2016
- First submitted
- 19 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT02665702
- Acronym / sponsor ID
- ENDO-SH-001
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 28 Jan 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.
The aim of this study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens
Detailed description
This study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens used as second-line treatment of advanced esophageal squamous cell carcinomas
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 NVB and DDP | Experimental | Drug: NVB, Drug: DDP, Drug: EndostarEndostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- According to the esophageal AJCC2009 7th to determine new stage IV esophageal cancer
- The subject has PD after first-line chemotherapy or radiation within a year
- Presence of at least one index lesion measurable by CT scan or MRI according to RECIST 1.1
- Can eat more than liquid diet; No signs before esophageal perforation
Key exclusion criteria (10 listed)
- Breast-feeding or pregnant women, no effective contraception if risk of conception exists
- Chronic diarrhea, enteritis, intestine obstruction which are not under control
- Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
- A second primary tumor (except skin basal cell carcinoma)
- 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
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 |
|---|---|---|
| NVBAlso: Vinorelbine Injection25mg/m2 ，D1，8 | Drug | Endostar Combined With NVB and DDP |
| DDPAlso: Cisplatin75mg/m2 ，D1 or 25mg/m2 D1-3 | Drug | Endostar Combined With NVB and DDP |
| EndostarAlso: endo15mg/d，d1-d7 civ | Drug | Endostar Combined With NVB and DDP |
Primary outcome
Progression Free Survival
Time frame: from the first cycle of treatment (day one) to two month after the last cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
- Individual participant dataSharing planned: Undecided
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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.
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 NVB, DDP and Endostar in people with Esophageal Squamous Cell Carcinoma, run by Fudan 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 15 inclusion and 10 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 28 Jan 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang jian Hua, PD (13916619284, changjianhua@163.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: from the first cycle of treatment (day one) to two month after the last cycle). 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 28 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.