Clinical trial NCT04518800: PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PEG-rhG-CSF
Pancreatic Cancer
Keywords: PEG-rhG-CSF
Secondary Prevention
Pancreatic Cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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；
* 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.

Primary outcomes:
measure: Incidence of degree 3-4 neutropenia in each cycle of chemotherapy
timeFrame: last 4 cycles(each cycle is 21 days)
Secondary outcomes:
measure: The incidence of febrile neutropenia in each cycle of chemotherapy
timeFrame: last 4 cycles(each cycle is 21 days)
measure: Incidence of chemotherapy dose adjustment due to neutropenia in each cycle of chemotherapy
timeFrame: last 4 cycles(each cycle is 21 days)
measure: The proportion of patients hospitalized due to neutropenia
timeFrame: last 4 cycles(each cycle is 21 days)
measure: The proportion of patients receiving antibiotics during the entire chemotherapy period.
timeFrame: last 4 cycles(each cycle is 21 days)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Guanghai Dai, PhD.
role: PRINCIPAL_INVESTIGATOR
References: