NCT03092895已完成2 期
A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or Chemotherapy (FOLFOX4 or GEMOX) in Subjects With Advanced Primary Liver Cancer（PLC）or Biliary Tract Carcinoma (BTC)
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
- 157
- 试验地点
- 7
- 主要终点
- The Safety and Tolerability
研究概览
简要总结
This an open-label，Non-Randominzed Phase 2 study to evaluate the Safety and Tolerability of SHR-1210 in combination with Apatinib or chemotherapy (FOLFOX4 or GEMOX regimen) in subjects with Advanced PLC.or BTC Participants with advanced PLC who failed or intolerable to prior systemic therapy will be treated with SHR-1210 plus Apatinib; Participants with advanced PLC or BTC who have never received prior systemic therapy will be treated with SHR-1210 plus FOLFOX4 or GEMOX regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced PLC or advanced BTC (including bile duct carcinoma and gallbladder carcinoma) ; not suitable to surgery or local regional treatment; with at least one measurable lesion per RECIST 1.
- •Arm A:Failed or intolerable to at least one prior systemic treatment for advanced PLC. Arm B:No previous systemic treatment for advanced PLC or BTC
- •ECOG Performance Status of 0 or
- •Child-Pugh Class A or B with 7 points .
- •Life Expectancy of at least 12 weeks.
- •Has controlled infection by Hepatitis B Virus (HBV DNA<500 IU/ml) or Hepatitis C Virus.
- •Adequate organ function.
- •Male or female participants of childbearing potential must be willing to use an adequate method of contraception starting with the first dose of study drug through 60 days for female subjects and 120 days for male subjects after the last dose of study drug.
- •Patient has given written informed consent.
排除标准
- •Known fibrolamellar HCC; Prior malignancy active with the previous 5 years except for locally curable cancers that have been apparently cured.
- •Known or occurrence of central nervous system (CNS) metastases.
- •Ascites with clinical symptoms.
- •Known or evidence of GI hemorrhage within the past 6 months.
- •Known or occurrence of hemorrhage/ thrombus.
- •Known or evidence of abdomen fistula, gastrointestinal perforation, or abdominal abscess within the past 2 months.
- •Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias.
- •Grade III~IV cardiac insufficiency, according to NYHA criteria or echocardiography check: LVEF<50%.
- •Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140mmHg, diastolic blood pressure > 90 mmHg).
- •Factors to affect oral administration (such as patients unable to swallow oral medications, chronic diarrhea and ileus etc. situations evidently affect drug oral medication and absorption).
- •History of hepatic encephalopathy.
- •Known history of human immunodeficiency virus (HIV) infection.
- •Active infection or an unexplained fever > 38.5°C during screening visits.
- •Has received a live vaccine within 30 days.
- •Prior or planning to organ transplantation including liver transplantation.
- •Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- •Proteinuria≥ 2+ or 24 hours total urine protein > 1.0 g.
- •Active known, or suspected autoimmune disease.
- •Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily. prednisone equivalent, are permitted in the absence of active autoimmune disease
- •Any loco-regional therapy to liver (included but not limited: resection, radiotherapy, TAE, TACE, TAI, RFA or PEI) within 4 weeks prior to study.
- •Prior therapy with anti-PD-1 or other anti-PD-1/anti-PD-L1 immunotherapy.
- •Known history of hypersensitivity to monoclonal antibodies or any components of the study drugs.
- •Treatment with anti-coagulation therapy(Warfarin or heparin) or anti-platelet therapy(aspirin at dose≥300mg/day, clopidogrel at dose≥75mg/day).
- •Pregnant or breast-feeding women.
- •According to the investigator, other conditions that may lead to stop the research.
研究组 & 干预措施
SHR-1210+Apatinib(Arm A）
Experimental
干预措施: SHR-1210 (Biological)
SHR-1210+Apatinib(Arm A）
Experimental
干预措施: Apatinib (Drug)
SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）
Experimental
干预措施: SHR-1210 (Biological)
SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）
Experimental
干预措施: FOLFOX4 (Drug)
SHR-1210+FOLFOX4 or GEMOX regimen(Arm B）
Experimental
干预措施: GEMOX (Drug)
结局指标
主要结局
The Safety and Tolerability
时间窗: Up to approximately 4 years
The incidence of adverse events (AEs) and Serious adverse events (SAEs) assessed by NCI-CTCAE v4.03
次要结局
- Objective Response Rate (ORR)(Up to approximately 4 years)
- Duration of Response (DoR)(Up to approximately 4 years)
- Disease Control Rate (DCR)(Up to approximately 4 years)
- Time to Progression (TTP)(Up to approximately 4 years)
- Overall Survival(Up to approximately 4 years)
- Time to Response (TTR)(Up to approximately 4 years)
- Progression-free Survival (PFS)(Up to approximately 4 years)
研究者
研究点 (7)
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