A Single-arm Phase II Study to Evaluate Camrelizumab in Combination With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This is a single arm, open-label, non-randomized and single-center phase II clinical study, to evaluate the safety, tolerance, and efficacy of Camrelizumab in combination with Apatinib in patients with advanced intrahepatic cholangiocarcinoma (ICC).
详细描述
It is estimated that 50 patients who met the study criteria will be enrolled in 3 years and treated with Camrelizumab plus Apatinib in SYSUCC. The investigators will follow up and collect subjects' data to evaluate the efficacy and safety of treatment, including objective response rate (ORR) and Progression-free Survival (PFS) and Overall Survival (OS), until disease progression or death. Histopathology and multi-omics data analysis will be used to explore potential biomarkers of treatment response.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed advanced ICC, or combined hepatocellular and cholangiocarcinoma (cHCC-CC, composition of cholangiocarcinoma >50%). nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation, or ablative therapies.
- •Have at least one measurable lesion (in accordance with RECIST v1.1); the measurable lesion has a long diameter ≥ 10 mm or lymphadenopathy has a short diameter ≥ 15 mm in spiral CT scan.
- •Child-Pugh Class: Grade A
- •ECOG-PS score 0 or 1
- •Life Expectancy of at least 3 months
- •Have the required screening laboratory values
排除标准
- •Extrahepatic cholangiocarcinoma (EHCC) and primary liver cancer. other active malignant tumors except for ICC within 3 years or simultaneously. Cured localized tumor, for example, basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate, carcinoma in situs of cervix, breast cancer in situ may be enrolled.
- •Any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can be controlled with hormone replacement therapy only can be enrolled]); subjects with skin diseases that does no need systemic treatment, for example, leukoderma, psoriasis, alopecia, those with controlled type I diabetes by insulin or those with asthma that has been completely resolved in childhood and with no need of any intervention can be enrolled; while subjects with asthma who need bronchodilator for medical intervention cannot be enrolled;
- •Use of strong CYP3A4/CYP2C19 inducers, including rifampicin (and its analogues) and St. John's Wort, or strong CYP3A4/CYP2C19 inhibitors within two weeks prior to signing informed consent form.
- •Previous treatment with other immune checkpoint inhibitors (include PD-1 antibody or other immunotherapy against PD-1/PD-L1), or previous use of Apatinib.
- •Known history of serious allergy to any monoclonal antibody or Apatinib.
- •Inability or unwilling to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption.
- •Previous or current presence of metastasis to central nervous system.
- •Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia or complications of severe pneumonia; oral or intravenous therapeutic antibiotics within two weeks prior to the start of study treatment (for example, subjects who are given with preventive antibiotics for prevention of urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible for participation in the study);
- •Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators, such as alcoholism, drug abuse, other serious diseases (including mental disorders) requiring concomitant therapy, with serious laboratory examination abnormality, with family or social factors, that may affect subject's safety.
研究组 & 干预措施
Camrelizumab combination with Apatinib
Camrelizumab 200mg, every 3 weeks, intravenous infused. Apatinib 250mg, once a day, orally. Until progression or unacceptable toxicity events develop.
干预措施: Camrelizumab (Drug)
Camrelizumab combination with Apatinib
Camrelizumab 200mg, every 3 weeks, intravenous infused. Apatinib 250mg, once a day, orally. Until progression or unacceptable toxicity events develop.
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Three years
A duration from the date of initial treatment to disease progression (defined by RECIST 1.1) or death of any cause.
次要结局
- Overall Survival (OS)(Three years)
- Objective Response Rate (ORR)(Three years)
- Disease Control Rate (DCR)(Two years)
- Duration of Response (DoR)(Two years)
- Time to Progression (TTP)(Two years)
- Adverse events (AE)(Two years)
研究者
Chen Min-Shan
Professor
Sun Yat-sen University