Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy (NCT04812002) | Clinical Trial Compass
UnknownPhase 2
Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy
China20 participantsStarted 2021-04-15
Plain-language summary
Gestational trophoblastic Neoplasia（GTN） is a kind of malignant tumor in women of childbearing age. It is easy to metastasized through the blood system in the early stage, so it is a relatively malignant tumor. The tumor is highly sensitive to chemotherapy, and low-risk patients have good prognosis, with survival rate and cure rate approaching 100%, but high-risk patients are prone to drug resistance, or relapse after remission. For relapsed, refractory, high-risk GTN, multiple remedies have been reported in the literature, but the remission rate is only 75-80%. For relapsed or refractory high-risk GTN, multiple remedies have been reported in the literature, but the remission rate is only 75-80%.
Currently, targeted therapy and immunotherapy are widely used in various refractory solid tumors. For GTN, there are also a number of related studies. In this study, PD-1 inhibitors combined with bevacizumab were used to treat refractory high-risk GTN with relapse or drug resistance after receiving previous second-line or above multidrug combination therapy, to study the efficacy and safety of the treatment regimen.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Signed Informed Consent
✓. Clinically diagnosed as recurrent or drug-resistant trophoblastic tumor
✓. After treatment with at least two or more multidrug chemotherapy regimens
✓. Take effective contraceptives during treatment
Exclusion criteria
✕. Previously, he had received anti-PD-1, anti-PD-L1, bevacizumab and other drugs;
✕. Within 2 weeks before the first administration, he had received anticancer Chinese patent medicine or immunomodulatory drugs;
✕
What they're measuring
1
PFS
Timeframe: From date of randomization until the date of first documented progression or death from any cause, whichever occurred first, or last follow-up for patients alive without progression, assessed up to approximately 24 months
Trial details
NCT IDNCT04812002
SponsorWomen's Hospital School Of Medicine Zhejiang University