Status:
RECRUITING
Study of PD-1 Antibody and Bevacizumab in the Treatment of High-risk GTN After Combined Chemotherapy
Lead Sponsor:
Women's Hospital School Of Medicine Zhejiang University
Conditions:
Gestational Trophoblastic Neoplasia
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 malign...
Detailed Description
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 mu...
Eligibility Criteria
Inclusion
- Signed Informed Consent
- Clinically diagnosed as recurrent or drug-resistant trophoblastic tumor
- After treatment with at least two or more multidrug chemotherapy regimens
- Survival is expected to exceed 3 months
- Age ≥18 years, age ≤75 years
- Karnofsky score ≥60分，ECOG score ≤2分
- No serious complications
- Take effective contraceptives during treatment
- Patients can be followed up as required
- 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
- Coagulation function, thyroid function and myocardial enzyme in the normal range
Exclusion
- 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;
- Within 2 years before the first administration, he had received active autoimmune disease requiring systemic treatment;
- Were receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to first administration;
- Clinically uncontrollable pleural effusion/peritoneal effusion is present;
- Allergic to PD-1 monoantibody, bevacizumab and other active ingredients or excipients；
- Failure to fully recover from toxicity and/or complications；
- History of HIV infection, untreated active hepatitis B, and active HCV infection subjects；
- Live vaccine was administered within 30 days prior to the first dose；
- Patients with serious or uncontrollable medical conditions who are not suitable for chemotherapy；
- Participating in clinical trials of other drugs at the same time or 4 weeks before the first administration。
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04812002
Start Date
April 15 2021
End Date
April 15 2026
Last Update
June 3 2022
Active Locations (1)
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1
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310000