Cadonilimab Combined With Gemcitabine and Cisplatin as First Line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma: A Single Center, Single Arm, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) per RECIST 1.1
研究概览
简要总结
TOPAZ-1 phase III trail demonstrated that the addition of immune checkpoint inhibitor anti-PD-L1 antibody improved progression-free survival (PFS) and overall survival (OS) compared to Gem/Cis alone. Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with gemcitabine and cisplatin as first Line therapy in patients with advanced intrahepatic cholangiocarcinoma. Eligible participants will receive cadonilimab (up to 12 months) plus gemcitabine and cisplatin (for maximum of 6-8 cycles) until radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first. The primary endpoint is objective response rate.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically diagnosed intrahepatic cholangiocarcinoma (ICC)
- •At least 1 measurable lesion (according to RECIST1.1)
- •Have not previously received any systemic treatment
- •Age 18-75 years old, both male and female
- •ECOG performance status score (PS score) 0-2 point
- •Adequate medullary hematopoiesis function: Neutrophils≥1.5*10^9/L; platelets≥100*10^9/L
- •Adequate renal function: creatinine clearance > 60ml/min
- •Adequate hepatic function: Bilirubin ≤ 1.5 times the upper limit of normal
- •No cardiac insufficiency or chest pain (medically uncontrollable); no myocardial infarction in the 12 months prior to study initiation
- •Expectation survival time over 3 months
- •The patient must sign an informed consent form
排除标准
- •History of another primary malignancy
- •Brain metastases or spinal cord compression
- •Uncontrolled intercurrent illness
- •Have active or previously recorded autoimmune or inflammatory diseases (eg Rheumatoid arthritis, psoriasis, systemic lupus erythematosus, AIDS, etc)
- •Have received allogeneic organ transplantation
- •Control of concurrent complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, poorly controlled arrhythmia, active interstitial lung disease ( ILD), severe chronic gastrointestinal disorders associated with diarrhea symptoms, may limit compliance with the psychiatric/social conditions required by the trial, and substantially increase the risk of adverse events or affect the ability of patients to sign written consent forms
- •History of active primary immunodeficiency
- •Pregnant or lactating women
- •Severe or uncontrolled infections
- •Patients with history of severe neurological or psychiatric illness, including dementia or epilepsy;
- •Patients with drug abuse, medical, psychological or social conditions that may interfere with the study results or the assessment of the study results;
- •Patients are unsuitable for the enrollment according to investigator's judgement.
研究组 & 干预措施
Cadonilimab+Gem/Cis
干预措施: Cadonilimab+Gem/Cis (Drug)
结局指标
主要结局
Objective response rate (ORR) per RECIST 1.1
时间窗: Up to two years
Defined as patients achieving a complete response \[CR\] or partial response \[PR\]
次要结局
- Overall survival (OS)(Up to two years)
- 6mo PFS rate per RECIST 1.1(at 6 months)
- Progression free survival (PFS) per RECIST 1.1(Up to two years)
- Desease control rate (DCR) per RECIST 1.1(Up to two years)
- adverse events(Up to two years)
研究者
Shen Feng
Professor and Chief Surgeon
Eastern Hepatobiliary Surgery Hospital