Camrelizumab Combined With Apatinib for Recurrent Resistant GTN (NCT04047017) | Clinical Trial Compass
CompletedPhase 2
Camrelizumab Combined With Apatinib for Recurrent Resistant GTN
China20 participantsStarted 2019-08-08
Plain-language summary
This study is to evaluate the efficacy and safety of camrelizumab plus apatinib in patients with high-risk chemo-refractory or relapsed GTN.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Patients with recurrent resistant GTN previously received twice or more combination chemotherapy before enrolment;
✓. In the 20000 FIGO staging and classification, a risk score of 7 and above 7 (Considered high risk) or resistant recurrent placental site trophoblastic tumor or resistant recurrent epithelial trophoblastic tumor;
✓. Aged 18-70 years;
✓. An Eastern Cooperative Oncology Group performance status of 0-2;
✓. abnormal serum HCG level;
✓. Expected survival ≥ 4 months;
✓. The function of vital organs meets the following requirements： Hemoglobin≥80g/L; Absolute neutrophil count≥1.5\*109/L；Platelets≥100
✓. Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration.
Exclusion criteria
✕. Previously exposed to other anti-angiogenic small-molecule TKI drugs, such as pazopanib, sorafenib, regorafenib, cilnitraz, etc. or anti-angiogenic mAbs such as bevacizumab ; or had used an anti-PD-1 antibody, an anti-CTLA-4 antibody, TCR-T, CAR-T and other immune therapy; or 4 weeks before the first administration participated in any other clinical trials of anticancer drugs; or before the first dose Live attenuated vaccines are accepted within 4 weeks or during the study period.
✕. Other malignant tumors have occurred in the past 3 years..
✕. Immunosuppressive drugs used within 14 days prior to the first use of SHR-1210, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (ie, no more than 10 mg/day of turmeric or equivalent drug physiological dose) Other corticosteroids).
✕. Late-stage patients with symptomatic, disseminated to visceral, short-term risk of life-threatening complications (including uncontrolled large amounts of exudate \[thoracic, pericardium, abdominal cavity\], pulmonary lymphangitis, and more than 30% liver involvement patients).
✕. Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function; subjects with vitiligo or complete remission asthma in childhood and without any intervention, all above can be included; asthma requiring medical intervention for bronchodilators should be excluded).
✕. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite with the optimal medical treatment.
✕. Grade II or higher myocardial ischemia, myocardial infarction or poor control arrhythmia (including male with QTc interval ≥ 450ms, or female with QTc interval≥ 470ms). According to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) \<50%; myocardial infarction occurred within 6 months before enrollment, New York Heart Association Level II or above failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, pericardial disease with clinically significant, or electrocardiogram suggesting acute ischemia or abnormal active conduction system.
✕. Abnormal coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy.