Advanced Gastrointestinal TumorsNCT03977077
Treatment of Advanced Gastrointestinal Tumors With Albumin Taxol
A study testing Albumin binding taxol in people with Advanced Gastrointestinal Tumors, run by Henan Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of domestic injection paclitaxel (albumin binding type) in patients with advanced digestive tract tumors,and to further explore the possible predictors of efficacy.In order to provide more effective chemotherapeutic drugs, prolong survival time and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastrointestinal Tumors
- What is being tested?
- Albumin binding taxol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Oct 2020
- Phase
- Interventional
- 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 aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen;
- ECOG PS 0-2；
- Expected survival time ≥3 months;
- According to RECIST1.1, at least one measurable lesion exists；
- The level of organ function must meet the following requirements（1）Blood routine examination standards must be met：HB≥90 g/L；ANC≥1.5×109/L； PLT≥80×109/L；（2）Liver function should meet the following criteria TBIL≤1.5×ULN；AST≤2.5×ULN；（3）Renal function should meet the following criteria: CrCL≥60 ml/min；
Who cannot join
- Pregnant or lactating women；
- Had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer;
- Active brain metastasis or severe disease;
- Grade 1 peripheral neuropathy (judged according to NCICTC standard for adverse reactions);
- Patients with allergy to research drugs, albumin or previous allergies;
- Severe mental or neurological disorders affecting the presentation or observation of adverse reactions;
- The investigator considers that there is any condition that may impair the subject or cause the subject to fail to meet or perform the study requirements.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Retrospective Clinical Study on the Efficacy and Safety of Injection Taxol (Albumin Binding Type) in the Treatment of Patients With Advanced Gastrointestinal Tumors
The purpose of this study was to evaluate the safety and efficacy of domestic injection paclitaxel (albumin binding type) in patients with advanced digestive tract tumors,and to further explore the possible predictors of efficacy.In order to provide more effective chemotherapeutic drugs, prolong survival time and improve quality of life for patients with advanced digestive tract tumors.
- Conditions
- Advanced Gastrointestinal Tumors
- Being tested
- Albumin binding taxol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin binding taxolDrug
125mg/m2, d1, 8, intravenous infusion for 30min, 1 cycle every 3 weeks;Other combined chemotherapy drugs and drug doses shall be administered by clinicians according to the guidelines and the actual situation of clinical patients.
| Study group | Role | What they receive |
|---|---|---|
| Albumin binding taxol | Experimental | Not described Receives: Drug: Albumin binding taxol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Progression free survival (PFS) is the time between the onset of treatment and the observation of disease progression or death from any cause.
Measured: up to 2 year
Secondary outcomes (2)
Objective remission rate (ORR)
Defined as the proportion of patients with a documented complete response, and partial response (CR+PR)
Measured: up to 2 year
Overall survival
The Overall survival (OS) is defined as the date from random grouping to death from any cause.
Measured: up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastrointestinal TumorsStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977077
- Sponsor's protocol ID
- AYGAS-0531
- Status last verified
- May 2019
- First submitted
- 3 Jun 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Clinical Study on the Efficacy and Safety of Injection Taxol (Albumin Binding Type) in the Treatment of Patients With Advanced Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT03977077
- Acronym / sponsor ID
- AYGAS-0531
- Conditions
- Advanced Gastrointestinal Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 6 Jun 2019 (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 study was to evaluate the safety and efficacy of domestic injection paclitaxel (albumin binding type) in patients with advanced digestive tract tumors,and to further explore the possible predictors of efficacy.In order to provide more effective chemotherapeutic drugs, prolong survival time and improve quality of life for patients with advanced digestive tract tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albumin binding taxol | Experimental | Drug: Albumin binding taxol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥18 years with advanced esophageal cancer, gastric cancer, pancreatic cancer and gallbladder (duct) confirmed histologically by albumin paclitaxel chemotherapy regimen;
- ECOG PS 0-2；
- Expected survival time ≥3 months;
- According to RECIST1.1, at least one measurable lesion exists；
- The level of organ function must meet the following requirements（1）Blood routine examination standards must be met：HB≥90 g/L；ANC≥1.5×109/L； PLT≥80×109/L；（2）Liver function should meet the following criteria TBIL≤1.5×ULN；AST≤2.5×ULN；（3）Renal function should meet the following criteria: CrCL≥60 ml/min；
Key exclusion criteria (7 listed)
- Pregnant or lactating women；
- Had a history of other primary malignancies within 5 years, with the exception of cured basal cell skin cancer and cured cervical cancer;
- Active brain metastasis or severe disease;
- Grade 1 peripheral neuropathy (judged according to NCICTC standard for adverse reactions);
- Patients with allergy to research drugs, albumin or previous allergies;
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 |
|---|---|---|
| Albumin binding taxol125mg/m2, d1, 8, intravenous infusion for 30min, 1 cycle every 3 weeks;Other combined chemotherapy drugs and drug doses shall be administered by clinicians according to the guidelines and the actual situation of clinical patients. | Drug | Albumin binding taxol |
Primary outcome
Progression free survival (PFS)
Time frame: up to 2 year
Progression free survival (PFS) is the time between the onset of treatment and the observation of disease progression or death from any cause.
2 secondary outcomes
Objective remission rate (ORR)
Time frame: up to 2 year
Overall survival
Time frame: up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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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 study testing Albumin binding taxol in people with Advanced Gastrointestinal Tumors, run by Henan Cancer 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 6 Jun 2019. 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.
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 Xifang Hou (15136130286, houxinfang2013@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 (PFS) (time frame: up to 2 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 6 Jun 2019.