Status:
COMPLETED
Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy
Lead Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Non-Myeloid Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelos...
Eligibility Criteria
Inclusion
- Histopathology and/or cytology diagnosed as breast cancer (BC) or non-small cell lung cancer (NSCLC), and patients with breast cancer is suitable to receive TAC(Docetaxel,Doxorubicin combined with Cyclophosphamide) chemotherapy, while patients with NSCLC is suitable to receive DC(Docetaxel combined with Carboplatin) chemotherapy.
- Age ≥18 yrs.
- Weight ≥45 kg.
- Karnofsky Score ≥ 70.
- Life Expectancy ≥ 3 months.
- Peripheral blood test: WBC≥3.5×10\^9 cells/L, PLT≥100×10\^9 cells/L. ANC≥1.5×10\^9 cells/L.
- Understand and voluntarily sign the informed consent form.
Exclusion
- Receiving chemotherapy within two months prior to screening.
- Previously or plan to receive radiotherapy (\>25% total bone marrow volume).
- Evidence of tumor metastasis in bone marrow.
- Lack of awareness.
- Uncontrolled infection or using of antibiotics within 72hrs prior to screening.
- Previously received or plan to undergoing bone marrow or organ transplants.
- Patients with bleeding tendency, e.g. prolonged prothrombin time of more than 3 seconds.
- Dysfunction in heart,lung, liver, kidney, or other major organs or systems; ALT\>2.5 ULN (upper limit of normal), TBil \>2.5 ULN (ALT\>2.5 ULN, total bilirubin \>2.5 ULN for patients with liver metastasis), HBsAg positive, anti-HCV positive, evidence of liver decompensation, or Cr \>1.5 ULN.
- Pregnant or lactating females.
- Malignancy other than BC or NSCLC.
- Hypersensitivity to rhG-CSF or any component of the investigational Products.
- Subject enrolled in any other studies within 3 months prior to screening.
- Drug abuser or alcoholics.
- Any other conditions which in the opinion of the investigator precluded enrollment into the study.
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT04466137
Start Date
October 16 2020
End Date
September 1 2021
Last Update
February 9 2022
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China