Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Signed Informed Consent 2. Clinically diagnosed as recurrent or drug-resistant trophoblastic tumor 3. After treatment with at least two or more multidrug chemotherapy regimens 4. Survival is expected to exceed 3 months 5. Age ≥18 years, age ≤75 years 6. Karnofsky score ≥60分，ECOG score ≤2分 7. No serious complications 8. Take effective contraceptives during treatment 9. Patients can be followed up as required 10. Blood test within 3 days: ANC≥1.5×109/L, PT ≥100×109/L, Hb≥90g/L, BIL ≤ 1.5 times of the high limit of normal value, ALT/ALST ≤ 1.5 times of the high limit of normal value, BUN and Cr≤ normal value 11. Coagulation function, thyroid function and myocardial enzyme in the normal range Exclusion Criteria: 1. Previously, he had received anti-PD-1, anti-PD-L1, bevacizumab and other drugs; 2. Within 2 weeks before the first administration, he had received anticancer Chinese patent medicine or immunomodulatory drugs; 3. Within 2 years before the first administrati