A Phase 2 interventional study of PD-1 inhibitor， bevacizumab in Gestational Trophoblastic Neoplasia, sponsored by Women's Hospital School Of Medicine Zhejiang University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Phase 2, Interventional, and Treatment
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.
In this study, PD-1 inhibitors combined with bevacizumab were used to treat refractory high-risk trophoblastic tumor (GTN) with relapse or drug resistance after receiving previous two-line or above multidrug combination therapy, and the efficacy and safety of the two drugs were evaluated.
Patients who meet the requirements will sign the informed consent and be enrolled voluntarily. This project is a single-arm study without a control group. Twenty patients are expected to be enrolled, and there are 4 centers competing for enrollment.
All patients received at least two-line multidrug combination therapy, and some patients may have undergone or planned surgery and/or radiation therapy. Through the HCG value and measurable changes in the size of the lesions, we can understand the changes of the disease. The primary endpoints were PFS and ORR Whenever, for whatever reason, the subject does not complete the clinical trial observation, is considered to be an abscission case. When the subject falls off, the researcher must fill in the reason for the fall off in the CRF, and contact the subject as much as possible, complete the items that can be evaluated, and record the time of the last medication to prepare for the analysis of its efficacy and safety. The CRF should be kept for future reference
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
participants received 200mg of PD-1 inhibitors combined 15mg of bevacizumab per square body surface area intravenously every 3 weeks
Drug: PD-1 inhibitor， bevacizumab
Both drugs are given intravenously
Also known as: Camrelizumab for Injection
PFS
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first.
Time frame: 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
ORR
ORR is defined as the rate of CR or PR.Partial response (PR) is defined as a reduction of HCG by 50% or more from the starting value in continuous measurements; Complete response (CR) is defined as HCG normalization of continuous measurements at least two weeks intervals.
Time frame: From date of randomization until PD or death from any cause, assessed up to 24 months
Plan to share: No
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Women's Hospital School Of Medicine Zhejiang University