Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia: a Cohort, Open-label, Phase 2 Trial
The purpose of this study is to evaluate the efficacy and safety of camrelizumab and apatinib as combination therapy in patients with ultra high-risk (Cohort A) and high-risk chemo-refractory or relapsed (Cohort B) gestational trophoblastic neoplasia (GTN). Eligible patients will receive camrelizumab plus apatinib plus chemotherapy. Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent.
• Woman aged 18-60 years;
• Previously untreated patients with ultra high-risk GTN(Cohort A) or high-risk chemo-refractory or relapsed GTN (Cohort B);
• No previous chemotherapy or radiotherapy for ultra high-risk GTN(Cohort A)and have previously received two or more lines of combination chemotherapies for high-risk chemo-refractory or relapsed GTN (Cohort B);
• Patients with ultra high-risk GTN (FIGO stages I-III: score ≥13 and stage IV) according to the International Federation of Gynecology and Obstetrics (FIGO) 2000 staging and risk factor scoring system(Cohort A)and patients with a prognostic score ≥7 (Cohort B);
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Patients with abnormal serum hCG level (≥5 IU/L);
• Expected survival ≥ 4 months;
• The function of vital organs meets the following requirements:
• hemoglobin ≥90 g/L, absolute neutrophil count ≥1·5×109/L, platelets ≥100×109/L; creatinine ≤1·5 × upper limit of normal (ULN), urea nitrogen ≤2·5×ULN; total bilirubin ≤ULN, alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN, albumin ≥25 g/L; thyroid stimulating hormone ≤ULN (if thyroid stimulating hormone is abnormal, normal T3 and T4 can also be acceptable).
• Female patients of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (e.g., intrauterine device, contraceptive or condom) during the study period and within 6 months of the last study drug administration.
⁃ The patient should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form.