Actively Recruiting
Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen
Led by Shandong University · Updated on 2024-05-07
83
Participants Needed
6
Research Sites
137 weeks
Total Duration
On this page
Sponsors
S
Shandong University
Lead Sponsor
C
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study was to observe the efficacy and safety of Efbemalenograstim Alfa in the prevention of absolute neutrophil count (ANC) reduction after chemotherapy in Ovarian and Cervical cancer patients at risk of platinum-containing chemotherapy with risk factors in febrile neutropenia (FN).
CONDITIONS
Official Title
Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Diagnosis of first-line epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) or first-line/recurrent metastatic cervical cancer
- Planned treatment with 3 to 6 cycles of paclitaxel plus carboplatin or cisplatin with or without bevacizumab
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- Expected survival longer than 3 months
- Neutrophil count (ANC) at least 2.0 x 10^9/L, hemoglobin at least 90 g/L, and platelets at least 80 x 10^9/L before enrollment
- Presence of at least one risk factor increasing febrile neutropenia risk, such as age over 65, prior chemotherapy or radiotherapy, persistent neutropenia, bone marrow tumor involvement, recent surgery or open wounds, liver or kidney dysfunction, history of febrile neutropenia, certain blood diseases, immunosuppression, or poor nutritional/physical status
- Left ventricular ejection fraction above 50%
- Women not capable of reproduction (postmenopausal for at least 1 year or sterilized) or using effective contraception from 1 month before the trial until 30 days after
- Willingness to provide informed consent and comply with study procedures
- Investigator's assessment that patient can tolerate Efbemalenograstim Alfa treatment
You will not qualify if you...
- Uncontrolled infection or use of systemic antibiotics within 72 hours before chemotherapy
- Pregnant or breastfeeding women
- History of bone marrow or stem cell transplantation
- Other cancers besides primary ovarian or cervical cancer
- Treatment with recombinant human granulocyte colony-stimulating factor within 6 weeks before enrollment
- Psychiatric illness or brain metastases
- Evidence of acute heart failure, cardiomyopathy, or recent heart attack
- Conditions causing enlarged spleen
- Acute infection, chronic active hepatitis B within 1 year (unless negative for hepatitis B antigen), or hepatitis C
- Allergy to the study drug or its components, or to rubber
- Positive test for HIV or AIDS
- Active tuberculosis or recent exposure without negative skin test or treatment
- Sickle cell anemia
- Use of other investigational drugs within 1 month before enrollment
- Alcohol or drug abuse affecting compliance
- Any condition or symptom that may make participation unsafe or affect assessment of adverse events, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Xiangya Hospital, Central South University,
Changsha, Hunan, China
Not Yet Recruiting
2
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, China
Not Yet Recruiting
3
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
4
Qingdao Central Hospital, The Second Affiliated Hospital of Medical College of Qingdao University,
Qingdao, Shandong, China
Not Yet Recruiting
5
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
Research Team
L
Limei Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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