Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor
Launched by WEIGUO LV · Dec 20, 2015
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring the effectiveness and safety of a combination of two chemotherapy drugs, paclitaxel and cisplatin, for treating women with high-risk gestational trophoblastic tumors (a type of tumor that can occur after pregnancy). The trial is currently looking for female participants, specifically Chinese women aged 60 and younger, who have been diagnosed with certain stages of this condition and meet other health criteria.
To be eligible, participants need to have a specific risk score and good overall health, meaning they can carry out daily activities with some assistance. Those who join the trial will receive the chemotherapy treatment and will be monitored for how well the drugs work and any side effects they may experience. It’s important for potential participants to understand that they need to provide written consent to join and that they cannot be part of other clinical trials at the same time. This study aims to improve treatment options for women facing this challenging diagnosis.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Patients who International Federation of Gynecology and Obstetrics (FIGO) Stage I, II, or III criteria for high-risk gestational trophoblastic neoplasia (GTN) and stage Ⅳ cases
- • World Health Organization(WHO) risk score ≥7, and less than 13
- • Age≤60 years; female, Chinese women
- • Initial treatment is chemotherapy
- • Performance status: Karnofsky score≥60
- • Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal,blood urea nitrogen, Cr≤ normal
- • Provide written informed consent.
- Exclusion Criteria:
- • Patients with unconfirmed diagnosis of GTN
- • Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
- • WHO risk score less than 7
- • With severe or uncontrolled internal disease, unable to receive chemotherapy
- • Concurrently participating in other clinical trials
- • Unable or unwilling to sign informed consents
- • Unable or unwilling to abide by protocol
About Weiguo Lv
Weiguo Lv is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on rigorous study design and adherence to regulatory standards, Weiguo Lv collaborates with leading researchers and institutions to facilitate the development of new treatments across various therapeutic areas. The organization prioritizes patient safety and ethical considerations while striving to accelerate the delivery of groundbreaking therapies to the market. Through its comprehensive approach to clinical trial management, Weiguo Lv aims to contribute significantly to the evolution of healthcare and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hangzhou, Zhejiang, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials