OncoMatch/Clinical Trials/NCT05139095
Camrelizumab Plus Apatinib in Patients With High-risk Gestational Trophoblastic Neoplasia
Is NCT05139095 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Camrelizumab plus apatinib CohortA and Camrelizumab plus apatinib Cohort B for gestational trophoblastic neoplasia.
Treatment: Camrelizumab plus apatinib CohortA · Camrelizumab plus apatinib Cohort B — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Required: Stage I, II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: combination chemotherapy
previously received two or more lines of combination chemotherapies for high-risk chemo-refractory or relapsed GTN (Cohort B)
Cannot have received: chemotherapy
Exception: ultra high-risk GTN (Cohort A)
No previous chemotherapy or radiotherapy for ultra high-risk GTN（Cohort A）
Cannot have received: radiotherapy
Exception: ultra high-risk GTN (Cohort A)
No previous chemotherapy or radiotherapy for ultra high-risk GTN（Cohort A）
Cannot have received: immunotherapy
Previous treatment with immunotherapy drugs (including antibodies targeting PD-1, PD-L1, cytotoxic T-lymphocyte-associated protein 4, T-cell receptor, chimeric antigen receptor T-cell therapy, and other immunotherapy)
Cannot have received: anti-angiogenic small-molecule tyrosine kinase inhibitor (pazopanib, sorafenib, regorafenib)
anti-angiogenic small-molecule tyrosine kinase inhibitors (such as pazopanib, sorafenib, or regorafenib)
Cannot have received: anti-angiogenic monoclonal antibody (bevacizumab)
anti-angiogenic monoclonal antibodies (such as bevacizumab)
Lab requirements
Blood counts
hemoglobin ≥90 g/L, absolute neutrophil count ≥1·5×10^9/L, platelets ≥100×10^9/L
Kidney function
creatinine ≤1·5 × ULN, urea nitrogen ≤2·5×ULN
Liver function
total bilirubin ≤ULN, alanine aminotransferase and aspartate aminotransferase ≤2·5×ULN, albumin ≥25 g/L
Cardiac function
Grade II or higher myocardial ischemia, myocardial infarction or poorly controlled arrhythmia (females with QTc interval ≥470 ms); grade III to IV cardiac insufficiency according to NYHA criteria, or cardiac color Doppler ultrasound evidence of left ventricular ejection fraction <50%; myocardial infarction, NYHA grade II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or abnormal active conduction system occurring within 6 months before enrolment [excluded]
hemoglobin ≥90 g/L, absolute neutrophil count ≥1·5×10^9/L, platelets ≥100×10^9/L; creatinine ≤1·5 × 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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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