PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer

NCT ID: NCT04518800

Last Updated: 2020-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-18
• Study Completion Date: 2022-02-18

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.

Conditions

PEG-rhG-CSF; Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Jin Youli(PEG-rhG-CSF)

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dai, Guanghai

Professor and chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guanghai Dai, PhD.

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Guanghai Dai, PhD.

Role: CONTACT

daigh60@sohu.com

13801232381

Facility Contacts

Guanghai Dai, PhD.

Role: primary

daigh301@vip.sina.com

13801232381

Other Identifiers

CSPC-JYL-PC-01

Identifier Type: -

Identifier Source: org_study_id