Advanced Pancreatic CancerNCT04239001
Efficacy and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor in Secondary Prevention of Albumin Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer
A study testing PEG-rhG-CSF in people with Advanced Pancreatic Cancer, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A prospective, open, one-arm clinical study to evaluate the efficacy and safety of jinyouli in the first-line treatment of advanced pancreatic cancer with albumin paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: albumin paclitaxel, 120mg / m2, intravenous infusion for 30 minutes, D1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- PEG-rhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Feb 2020to Jun 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age ≥ 18 years, ≤70 years;
- (2) Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
- (3) Neutropenia of ≥2 degree occurred with the albumin paclitaxel + S-1 regimen in the previous cycle.
- (4) KPS score≥70points;
- (5) The peripheral blood routine of the patients was normal: ANC ≥ 2.0x109 / L, platelet count ≥ 90 × 109 / L, HB ≥ 80g / L before enrollment, and there was no bleeding tendency;
- (6) Patients volunteered to participate in the trial and signed a written informed consent to be followed up.
Who cannot join
- (1) There are currently hard-to-control infections or systemic antibiotic treatment within 72 h of chemotherapy；
- (2) Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
- (3) Patients who had received bone marrow or hematopoietic stem cell transplantation within the previous 3 months；
- (4) Previous patients with other malignant tumors not cured, or brain metastases；
- (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value;
- (6) Renal function test: serum creatinine (Cr) exceeded the upper limit of normal value；
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- (7) Allergic to this product or other biological products derived from genetically engineered escherichia coli；
- (8) Suffering from a mental or nervous system disorder, lacking self-awareness or coordination；
- (9) Patients who are expected to have a short survival and have difficulty tolerating chemotherapy；
- (10) Pregnant and nursing female patients；
- (11) People who are using other drugs of the same category or are in clinical trials of other drugs；
- (12) The investigator judges patients who are not suitable for participation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital First medical center
Beijing
Guanghai Dai, 13801232381, daigh60@sohu.com
About this study
Official title: Prospective, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor in Secondary Prevention of Albumin Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer
A prospective, open, one-arm clinical study to evaluate the efficacy and safety of jinyouli in the first-line treatment of advanced pancreatic cancer with albumin paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: albumin paclitaxel, 120mg / m2, intravenous infusion for 30 minutes, D1. S-1, taken orally after meal, D1 - 14. (2) patients who met the input / discharge criteria were given jinyouli injections 24 hours after the end of intravenous infusion of albumin paclitaxel during the treatment period.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- PEG-rhG-CSF
- Keywords
- PEG-rhG-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, patients with pancreatic cancer who met the input / discharge criteria were given secondary prophylactic administration of the tested drug PEG-rhG-CSF.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF | Experimental | Jin Youli(PEG-rhG-CSF): jinyouli injection was given 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
Measured: It lasts 4 cycles(each cycle is 21 days)
Secondary outcomes (4)
The incidence of febrile neutropenia in each cycle of chemotherapy
Febrile neutropenia (FN) is defined as oral temperature >38.3 ° C (underarm temperature >38.1 ° C) or continuous measurement of oral temperature >38 ° C (underarm temperature >37.8 ° C) in 2 h, and ANC <0.5×10^9/L, or expected to be <0.5×10^9/L
Measured: It lasts 4 cycles(each cycle is 21 days)
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy
Measured: It lasts 4 cycles(each cycle is 21 days)
The proportion of patients hospitalized due to neutropenia
The proportion of patients hospitalized due to neutropenia
Measured: It lasts 4 cycles(each cycle is 21 days)
The proportion of patients receiving antibiotics during the entire chemotherapy period.
The proportion of patients receiving antibiotics during the entire chemotherapy period.
Measured: It lasts 4 cycles(each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study startFeb 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guanghai Dai, Principal investigator, Chinese PLA General Hospital First medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239001
- Sponsor's protocol ID
- CSPC -JYL-PC-01
- Status last verified
- Jan 2020
- First submitted
- 9 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open, One-arm Clinical Study Evaluating the Efficacy and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor in Secondary Prevention of Albumin Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04239001
- Acronym / sponsor ID
- CSPC -JYL-PC-01
- Conditions
- Advanced Pancreatic Cancer
- Keywords
- PEG-rhG-CSF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 23 Jan 2020 (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.
A prospective, open, one-arm clinical study to evaluate the efficacy and safety of jinyouli in the first-line treatment of advanced pancreatic cancer with albumin paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: albumin paclitaxel, 120mg / m2, intravenous infusion for 30 minutes, D1. S-1, taken orally after meal, D1 - 14. (2) patients who met the input / discharge criteria were given jinyouli injections 24 hours after the end of intravenous infusion of albumin paclitaxel during the treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF | Experimental | Drug: PEG-rhG-CSFJin Youli(PEG-rhG-CSF): jinyouli injection was given 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (1) Age ≥ 18 years, ≤70 years;
- (2) Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
- (3) Neutropenia of ≥2 degree occurred with the albumin paclitaxel + S-1 regimen in the previous cycle.
- (4) KPS score≥70points;
- (5) The peripheral blood routine of the patients was normal: ANC ≥ 2.0x109 / L, platelet count ≥ 90 × 109 / L, HB ≥ 80g / L before enrollment, and there was no bleeding tendency;
Key exclusion criteria (12 listed)
- (1) There are currently hard-to-control infections or systemic antibiotic treatment within 72 h of chemotherapy；
- (2) Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
- (3) Patients who had received bone marrow or hematopoietic stem cell transplantation within the previous 3 months；
- (4) Previous patients with other malignant tumors not cured, or brain metastases；
- (5) Liver function tests total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) are >2.5 times the upper limit of normal, if the above indicators are >5 times due to liver metastasis Upper limit of normal value;
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 |
|---|---|---|
| PEG-rhG-CSF24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, patients with pancreatic cancer who met the input / discharge criteria were given secondary prophylactic administration of the tested drug PEG-rhG-CSF. | Drug | PEG-rhG-CSF |
Primary outcome
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
Time frame: It lasts 4 cycles(each cycle is 21 days)
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
4 secondary outcomes
The incidence of febrile neutropenia in each cycle of chemotherapy
Time frame: It lasts 4 cycles(each cycle is 21 days)
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy
Time frame: It lasts 4 cycles(each cycle is 21 days)
The proportion of patients hospitalized due to neutropenia
Time frame: It lasts 4 cycles(each cycle is 21 days)
The proportion of patients receiving antibiotics during the entire chemotherapy period.
Time frame: It lasts 4 cycles(each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
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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.
Guanghai Dai principal investigator
Chinese PLA General Hospital First medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-rhG-CSF in people with Advanced Pancreatic Cancer, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. 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 6 inclusion and 12 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 23 Jan 2020. 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 Guanghai Dai (13801232381, daigh60@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy (time frame: It lasts 4 cycles(each cycle is 21 days)). 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 23 Jan 2020.