Treatment of high-risk gestational trophoblastic neoplasia with PD-1 antibody and bevacizumab

Phase II Single-arm Clinical Study of PD-1 Antibody and Bevacizumab in the Treatment of Relapsed or Refractory High-risk Gestational Trophoblasitc Neoplasia After Second-line or Above Combined Chemotherapy

This study is testing whether a combination of two medications can help people with tough-to-treat high-risk gestational trophoblastic neoplasia feel better after other treatments have failed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Women's Hospital School Of Medicine Zhejiang University (Academic / other)
• Drugs / interventions: bevacizumab, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04812002 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of combining PD-1 inhibitors with bevacizumab in patients with refractory high-risk gestational trophoblastic neoplasia (GTN) who have previously undergone at least two lines of chemotherapy. It is a single-arm trial involving 20 patients across four centers, focusing on those who have experienced relapse or drug resistance. The primary endpoints include progression-free survival (PFS) and overall response rate (ORR), assessed through HCG levels and changes in tumor size. Participants will be closely monitored for treatment outcomes and safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 75 with recurrent or drug-resistant GTN who have undergone at least two prior chemotherapy regimens.

Not a fit: Patients who have previously received anti-PD-1, anti-PD-L1, or bevacizumab are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with high-risk GTN who have limited options due to drug resistance.

How similar studies have performed: While there have been studies on targeted therapy and immunotherapy for GTN, the specific combination of PD-1 inhibitors and bevacizumab in this context is relatively novel.

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 administration, he had received active autoimmune disease requiring systemic treatment;
4. Were receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to first administration;
5. Clinically uncontrollable pleural effusion/peritoneal effusion is present;
6. Allergic to PD-1 monoantibody, bevacizumab and other active ingredients or excipients；
7. Failure to fully recover from toxicity and/or complications；
8. History of HIV infection, untreated active hepatitis B, and active HCV infection subjects；
9. Live vaccine was administered within 30 days prior to the first dose；
10. Patients with serious or uncontrollable medical conditions who are not suitable for chemotherapy；
11. Participating in clinical trials of other drugs at the same time or 4 weeks before the first administration。

Where this trial is running

Hangzhou, Zhejiang

• Women's Hospital School of Medicine Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Xing Xie, doctor — Women's Hospital School Of Medicine Zhejiang University
• Study coordinator: Xing Xie, phD

Conditions Gestational Trophoblastic Neoplasia; bevacizumab; pd-1; chemotherapy