PEG-rhG-CSFNCT04518800
PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer
A study testing Jin Youli(PEG-rhG-CSF) in people with PEG-rhG-CSF and Pancreatic Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
A prospective, open, single-arm clinical study to evaluate the efficacy and safety of jinyouli（PEG-rhG-CSF） in the first-line treatment of advanced pancreatic cancer with nab-paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: nab-paclitaxel, 260mg/m2, intravenous infusion for 30 minutes, D1, Q3W. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PEG-rhG-CSF, Pancreatic Cancer
- What is being tested?
- Jin Youli(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
- 18 Aug 2020to 18 Feb 2022
- 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
- Age ≥ 18 years, ≤70 years;
- Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
- Neutropenia of ≥2 degree occurred with the nab-paclitaxel + S-1 regimen in the previous cycle.
- KPS score≥70;
- The peripheral blood routine of the patients was normal: ANC ≥ 2.0x10^9/L, platelet count ≥ 90x10^9/L, HB ≥ 80g/L before enrollment, and there was no bleeding tendency;
- Patients volunteered to participate in the trial, signed a written informed consent, willing to be followed up.
Who cannot join
- There are uncontrollable infections at the moment or systemic antibiotic treatment within 72 h of chemotherapy；
- Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
- Patients who had received bone marrow or hematopoietic stem cell transplantation within 3 months；
- Patients with other malignancies that have not been cured or with brain metastases；
- Total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 ULN, or >5 ULN if there is liver metastasis;
- Serum creatinine (Cr) exceeded the upper limit of normal value；
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- Allergic to this product or other biological products derived from genetically engineered escherichia coli；
- Suffering from a mental or nervous system disorder, without self-awareness or coordination；
- Patients expected to have a short survival or have difficulty tolerating chemotherapy；
- Pregnant or lactating female patients；
- Patients using other drugs of the same category or in clinical trials of other drugs；
- Not suitable for participation at investigators' discretion.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Guanghai Dai, PhD., 13801232381, daigh301@vip.sina.com
About this study
Official title: Prospective, Open, Single-arm Clinical Study Evaluating the Efficacy and Safety of PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer
A prospective, open, single-arm clinical study to evaluate the efficacy and safety of jinyouli（PEG-rhG-CSF） in the first-line treatment of advanced pancreatic cancer with nab-paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: nab-paclitaxel, 260mg/m2, intravenous infusion for 30 minutes, D1, Q3W. S-1, 80-120mg, PO BID, D1-14, Q3W. (2) patients who met the eligibility criteria were given jinyouli injections 24 hours after the end of intravenous infusion of nab-paclitaxel during the treatment period.
- Conditions
- PEG-rhG-CSF, Pancreatic Cancer
- Being tested
- Jin Youli(PEG-rhG-CSF)
- Keywords
- PEG-rhG-CSF, Secondary Prevention, Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jin Youli(PEG-rhG-CSF)Drug
Jin Youli(PEG-rhG-CSF) 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
| Study group | Role | What they receive |
|---|---|---|
| Jin Youli(PEG-rhG-CSF) | Experimental | PEG-rhG-CSF Secondary Prevention：patients with pancreatic cancer who met the eligibility criteria were given secondary prophylactic administration of the Jin Youli(PEG-rhG-CSF). Receives: Drug: Jin Youli(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: last 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℃ or continuous measurement of oral temperature >38.1℃ in 1h, with ANC <0.5×10^9/L or expected to be <0.5×10^9/L
Measured: last 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: last 4 cycles(each cycle is 21 days)
The proportion of patients hospitalized due to neutropenia
The proportion of patients hospitalized due to neutropenia
Measured: last 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: last 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 posted19 Aug 2020
- Study start18 Aug 2020 (estimated)
- Primary completion18 Aug 2021 (estimated)
- Study completion18 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PEG-rhG-CSFStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai, Guanghai, Chinese PLA General Hospital
- Investigators
- Guanghai Dai, PhD., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518800
- Sponsor's protocol ID
- CSPC-JYL-PC-01
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 19 Aug 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 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open, Single-arm Clinical Study Evaluating the Efficacy and Safety of PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in the First-line Treatment of Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04518800
- Acronym / sponsor ID
- CSPC-JYL-PC-01
- Conditions
- PEG-rhG-CSF, Pancreatic Cancer
- Keywords
- PEG-rhG-CSF, Secondary Prevention, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 18 Aug 2020 (estimated)
- Primary completion
- 18 Aug 2021 (estimated)
- Study completion
- 18 Feb 2022 (estimated)
- First posted
- 19 Aug 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, single-arm clinical study to evaluate the efficacy and safety of jinyouli（PEG-rhG-CSF） in the first-line treatment of advanced pancreatic cancer with nab-paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: nab-paclitaxel, 260mg/m2, intravenous infusion for 30 minutes, D1, Q3W. S-1, 80-120mg, PO BID, D1-14, Q3W. (2) patients who met the eligibility criteria were given jinyouli injections 24 hours after the end of intravenous infusion of nab-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 |
|---|---|---|
| Jin Youli(PEG-rhG-CSF) | Experimental | Drug: Jin Youli(PEG-rhG-CSF)PEG-rhG-CSF Secondary Prevention：patients with pancreatic cancer who met the eligibility criteria were given secondary prophylactic administration of the Jin Youli(PEG-rhG-CSF). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years, ≤70 years;
- Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
- Neutropenia of ≥2 degree occurred with the nab-paclitaxel + S-1 regimen in the previous cycle.
- KPS score≥70;
- The peripheral blood routine of the patients was normal: ANC ≥ 2.0x10^9/L, platelet count ≥ 90x10^9/L, HB ≥ 80g/L before enrollment, and there was no bleeding tendency;
Key exclusion criteria (12 listed)
- There are uncontrollable infections at the moment or systemic antibiotic treatment within 72 h of chemotherapy；
- Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
- Patients who had received bone marrow or hematopoietic stem cell transplantation within 3 months；
- Patients with other malignancies that have not been cured or with brain metastases；
- Total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5 ULN, or >5 ULN if there is liver metastasis;
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 |
|---|---|---|
| Jin Youli(PEG-rhG-CSF)Jin Youli(PEG-rhG-CSF) 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 | Drug | Jin Youli(PEG-rhG-CSF) |
Primary outcome
Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
Time frame: last 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: last 4 cycles(each cycle is 21 days)
Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy
Time frame: last 4 cycles(each cycle is 21 days)
The proportion of patients hospitalized due to neutropenia
Time frame: last 4 cycles(each cycle is 21 days)
The proportion of patients receiving antibiotics during the entire chemotherapy period.
Time frame: last 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 19 Aug 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, PhD. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jin Youli(PEG-rhG-CSF) in people with PEG-rhG-CSF and Pancreatic Cancer, run by Chinese PLA General 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 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 19 Aug 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, PhD. (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: last 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 19 Aug 2020.