Esophageal CancerPhase 2NCT03649945
Endostatin Combined With Chemotherapy for Adjuvant Treatment of Esophageal Cancer
A Phase 2 study testing Docetaxel, Nedaplatin and Endostar in people with Esophageal Cancer, run by First Affiliated Hospital of Guangxi Medical University.
Trial summary
This is an open-label, randomized trial, it compares the efficacy and safety between apatinib combined chemotheray and chemotherapy for adjuvant treatment of esophageal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Docetaxel, Nedaplatin and Endostar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to May 2021
- 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
- IIA-IIIC phase esophageal squamous cell carcinoma confirmed by histopathology and immunohistochemistry.
- R0 resection has been performed at least before 4 weeks.
- ECOG PS score: 0-1 points.
- Estimated survival time: at least 12 weeks.
- No radiotherapy, chemotherapy or molecular targeted therapy before.
- Main organs are functional, which meet the following criteria:
Show all 10Show fewer
- Blood Routine:
- HB≥90 g/L（No blood transfusion within 14 days）, ANC≥1.5×109/L, PLT ≥80×109/L. Biochemical examination： ALB≥30g / L（No blood transfusion within 14 days）, ALT<2ULN； AST<2ULN TBIL≤1.5ULN； Plasma Cr≤1.5ULN；
- Volunteer with signed informed consent form, good compliance and good follow-up cooperation.
- Patients who the investigator believws they can benefit.
Who cannot join
- Those who have had other malignant tumors in the past or at the same time.
- Pregnant or lactating women.
- Patients with grade-II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTC interval ≥ 450 ms) and cardiac dysfunction according to NYHA criteria III to IV. Cardiac color Doppler examination: LVEF (left ventricular ejection) Score) <50%.
- Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++), and a history of gastrointestinal bleeding within 6 months.
- Have a history of mental illness or psychotropic substance abuse.
- Patients who have participated in other drug clinical trials within 4 weeks.
- According to the investigator's judgment, patients who are at a risk or have accompanying disease.
- Patients who believe that they are unsuitable for inclusion.
About this study
Official title: An Open-label, Randomized Clinical Trial of Recombinant Human Endostatin (Endo) Combined With Chemotherapy Compared With Chemotherapy for Adjuvant Treatment of Esophageal Cancer
This is an open-label, randomized trial, it compares the efficacy and safety between apatinib combined chemotheray and chemotherapy for adjuvant treatment of esophageal cancer
- Conditions
- Esophageal Cancer
- Being tested
- Docetaxel, Nedaplatin, Endostar
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
NedaplatinDrug
80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
EndostarDrug
7.5mg/m2，once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Test Group 1 | Active comparator | Docetaxel plus Nedaplatin combined with Endostar Receives: Drug: Docetaxel; Drug: Nedaplatin; Drug: Endostar |
| Test Group 2 | Active comparator | Docetaxel plus Nedaplatin Receives: Drug: Docetaxel; Drug: Nedaplatin |
| Control Group | No intervention | No medicine intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year disease-free survival rate
the percentage of the patients whose disease cannot be detected after curative therapy in three years
Measured: 3 years
Secondary outcomes (1)
overall survival
From the time of randomization to the time of death for any reason.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Ma, First Affiliated Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649945
- Sponsor's protocol ID
- HRGX06
- Status last verified
- Aug 2018
- First submitted
- 26 Aug 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized Clinical Trial of Recombinant Human Endostatin (Endo) Combined With Chemotherapy Compared With Chemotherapy for Adjuvant Treatment of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03649945
- Acronym / sponsor ID
- HRGX06
- Conditions
- Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 28 Aug 2018 (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.
This is an open-label, randomized trial, it compares the efficacy and safety between apatinib combined chemotheray and chemotherapy for adjuvant treatment of esophageal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Group 1 | Active comparator | Drug: Docetaxel, Drug: Nedaplatin, Drug: EndostarDocetaxel plus Nedaplatin combined with Endostar |
| Test Group 2 | Active comparator | Drug: Docetaxel, Drug: NedaplatinDocetaxel plus Nedaplatin |
| Control Group | No intervention | –No medicine intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- IIA-IIIC phase esophageal squamous cell carcinoma confirmed by histopathology and immunohistochemistry.
- R0 resection has been performed at least before 4 weeks.
- ECOG PS score: 0-1 points.
- Estimated survival time: at least 12 weeks.
- No radiotherapy, chemotherapy or molecular targeted therapy before.
Key exclusion criteria (8 listed)
- Those who have had other malignant tumors in the past or at the same time.
- Pregnant or lactating women.
- Patients with grade-II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTC interval ≥ 450 ms) and cardiac dysfunction according to NYHA criteria III to IV. Cardiac color Doppler examination: LVEF (left ventricular ejection) Score) <50%.
- Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood ++), and a history of gastrointestinal bleeding within 6 months.
- Have a history of mental illness or psychotropic substance abuse.
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 |
|---|---|---|
| Docetaxel75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles | Drug | Test Group 1, Test Group 2 |
| Nedaplatin80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles | Drug | Test Group 1, Test Group 2 |
| Endostar7.5mg/m2，once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles | Drug | Test Group 1 |
Primary outcome
3 year disease-free survival rate
Time frame: 3 years
the percentage of the patients whose disease cannot be detected after curative therapy in three years
1 secondary outcome
overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Nedaplatin and Endostar in people with Esophageal Cancer, run by First Affiliated Hospital of Guangxi Medical University.
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 10 inclusion and 8 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
3 year disease-free survival rate (time frame: 3 years). 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 Aug 2018.