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UNKNOWNPHASE2

Bemalenograstim Alfa for the Prevention in Patients With Colorectal Cancer/Pancreatic Cancer

A Multi-cohort, Open-label, Multicenter Exploratory Clinical Study of Bemalenograstim Alfa for the Prevention of Reduced ANC in Patients With Colorectal Cancer/Pancreatic Cancer Following a Bi-weekly Chemotherapy

NCT06134765•Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

A multi-cohort, open-label, multicenter exploratory clinical study of Bemalenograstim alfa for the prevention of reduced absolute neutrophil count(ANC) in patients with colorectal cancer/pancreatic cancer following a bi-weekly chemotherapy regimen.A total of 89 patients are planned to be enrolled.

Detailed Description

This multi-cohort, open-label, multicenter exploratory clinical study enrolled 89 patients with colorectal cancer and pancreatic cancer who were scheduled to receive at least 2 courses of a two-week chemotherapy regimen. The study was divided into two cohorts: Cohort 1 was colorectal cancer or pancreatic cancer patients receiving FOLFOXIRI or mFOLFIRINOX in combination with or without targeted drugs, and cohort 2 was colorectal cancer patients receiving FOLFIRI in combination with or without targeted drugs. Patients meeting the inclusion criteria received Bemalenograstim alfa injection (20mg/ time, subcutaneous injection) 24-48h after each course of chemotherapy, and Bemalenograstim alfa injection was used until the change of chemotherapy regimen or the fourth course of chemotherapy, whichever occurred first. After the subjects completed 2 courses of treatment, the follow-up treatment was carried out according to the diagnosis and treatment routine. Investigators need to ensure that the first course of chemotherapy is at the recommended dose; For the second to fourth course of treatment, delayed dosing or dose adjustment due to toxicity is allowed, and the chemotherapy dose is allowed to be adjusted by ±10%.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. The patients voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up;
•2. Age 18 and above, male or female;
•3. Patients with locally advanced or advanced colorectal or pancreatic cancer confirmed by histology or cytology are scheduled to receive at least 2 courses of FOLFIRI, FOLFOXIRI, or mFOLFIRINOX with or without targeted therapy as part of first-line therapy (excluding those who relapse within 6 months after the end of adjuvant therapy) ;
•4. Eastern Cancer Collaboration Group (ECOG) physical status (PS) score: 0-1;
•5. Adequate organ and bone marrow function meets the following criteria:
•1. Blood routine examination standards should be met (no blood transfusion or blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct): hemoglobin content (HB) ≥80g/L; Neutrophil count (ANC) ≥1.5×109/L; Platelet count (PLT) ≥100×109/L.
•2. Biochemical examination shall meet the following criteria: Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN); ALT and AST ≤ 2.5 ULN; If with liver metastasis, ALT and AST ≤ 5× ULN; Serum creatinine ≤ 1.5× ULN.
•3. Left ejection fraction \>50%.
•6. Infertile women, i.e. those who have been through menopause for at least one year or who have undergone sterilization (bilateral tubal ligation, double ovaries removal, or hysterectomy); Fertile patients agreed to use appropriate contraceptive methods: condoms, foam, gel, diaphragm, intrauterine device (IUD), birth control pills (given orally or by injection) for 1 month before the start of the trial and 30 days after the end of the study.
•7. The investigators determined that the patient could tolerate the treatment of Bemalenograstim Alfa.

Exclusion Criteria

•1. Acute congestive heart failure, cardiomyopathy, or myocardial infarction as diagnosed by clinical, electrocardiogram or other means;
•2. Rubber allergic people;
•3. Patients who had received radiotherapy for bone lesions (patients who had received radiotherapy for lesions other than bone lesions could be enrolled 4 weeks later) ;
•4. Have received a bone marrow or stem cell transplant;
•5. Pregnant or lactating women;
•6. Known to be seropositive for human immunodeficiency virus (HIV) or have AIDS;
•7. Active tuberculosis disease; Or a recent history of contact with a person with TB, unless the tuberculin test is negative, Or tuberculosis patients undergoing treatment; Or a chest radiograph to check suspected cases;
•8. Patients with alcohol or substance abuse, which affected their adherence to the study;以上
•9. Known allergy to granulocyte colony-stimulating factors or excipients of drugs;
•10. Received recombinant human granulocyte stimulating factor treatment within 6 weeks before inclusion;
+3 more criteria

Locations (1)

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, China

Key Dates

Start Date

November 30, 2023

Primary Completion Date

October 30, 2024

Completion Date

March 30, 2025

Last Updated

November 18, 2023

Enrollment

ESTIMATED participants

Conditions

Colorectal CancerPancreatic Cancer

Interventions

Bemalenograstim alfa

DRUG

Contacts

Caixia Dong

CONTACT

+86-15068882349 dcx_1982@163.com

Ying Yuan

CONTACT

+86-13858193601 yuanying1999@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Bemalenograstim Alfa for the Prevention in Patients With Colorectal Cancer/Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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