NCT04047017已完成2 期
Camrelizumab Combined With Apatinib for Recurrent Resistant Gestational Trophoblastic Neoplasia: a Phase 2, Single-arm, Prospective Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ORR(objective response rate)
研究概览
简要总结
This study is to evaluate the efficacy and safety of camrelizumab plus apatinib in patients with high-risk chemo-refractory or relapsed GTN.
详细描述
Apatinib is an oral small-molecule tyrosine kinase inhibitor that selectively binds to and inhibits VEGF receptor 2. Novel immunotherapy using the immune checkpoint inhibitors such as anti-PD-1 antibody has received much attention. Camrelizumab as one of the anti-PD-1 drug have impressive clinical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •*109/L; Creatinine≤1.5 times ULN; Urea nitrogen≤2.5 times ULN; Total Bilirubin≤ULN; ALT and AST ≤ 2.5 times ULN; Albumin≥25g/L; TSH≤ULN(if TSH is abnormal, normal T3 and T4 also can acceptable)
- •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.
- •The subject 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
排除标准
- •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.
- •Half of a teaspoons (2.5 ml) or more hemoptysis was found within the first 2 months or there were significant clinical bleeding symptoms or clearly propensity bleeding within 3 months before participant in the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ or above in baseline or vasculitis; artery or venous thrombosis events within 6 months prior to the study, such as cerebrovascular accidents (Including transient ischemic attacks, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism.
- •Severe infections within 4 weeks prior to accept medication (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever during screening/first administration >38.5 °C
- •Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders.
- •Major surgical procedures were performed within 4 weeks before the first administration. Or open wounds or fractures.
- •There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction. Or sinus or perforation of empty organs within 6 months.
- •Routine urine test indicated that urinary protein (++) or more, confirmed urinary protein (>1.0 g) within 24 hours.
- •Patients with a history of allergy may be potentially allergic or intolerant to Apatinib and biological agents SHR-
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA (> 500 IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of the analysis method) or co-infection with hepatitis B and hepatitis C.
- •There is any situation that may damage the subject or cause the subject to fail to meet or implement the research requirements.
研究组 & 干预措施
Test group
Experimental
Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle. Apatinib :250 mg po qd
干预措施: Apatinib (Drug)
Test group
Experimental
Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle. Apatinib :250 mg po qd
干预措施: Camrelizumab (Drug)
结局指标
主要结局
ORR(objective response rate)
时间窗: Up to one years
the proportion of patients with complete or partial response according to serum hCG level
次要结局
- DoR（duration of response）(Up to one years)
- OS (overall survival)(Up to one years)
- PFS(progression free survival)(Up to one years)
- Safety as measured by adverse events(Up to one years)
研究者
xiang yang
Chief
Peking Union Medical College Hospital
研究点 (1)
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