NCT05877001招募中2 期
An Open Label, Single-center Study on the Safety of Hepatic Arterial Infusion Chemotherapy Combined With Tislelizumab and Regorafenib in Patients With Advanced Treated Colorectal Liver Metastases
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年5月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety profiles by NCI-CTCAE version 5 .0
研究概览
简要总结
Tislelizumab is an anti-PD-1 monoclonal antibody with high binding affinity for PD-1 and with minimized Fcγ receptor binding on macrophages. Regorafenib has been approved in mCRC by CFDA. Hepatic arterial infusion chemotherapy has a high local control rate for liver metastases. NCCN guidelines and several expert consensus recommend that regional hepatic arterial infusion chemotherapy can be considered as a "rescue treatment" for patients with colorectal cancer liver metastases who fail to receive first-line or second-line systemic chemotherapy, which can significantly prolong the overall survival of patients.
详细描述
The investigators aimed to evaluated the safety and efficacy of HAIC combined with Tislelizumab and Regorafenib in patients with advanced treated colorectal liver metastases. This study is a prospective, open label, single-center clinical study and the sample size is 20.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years old
- •Histologically or cytologically confirmed colorectal cancer with unresectable or surgical contraindicated liver metastases
- •Extrahepatic metastases are allowed and the primary tumor load is assessed to be intrahepatic by two or more attending physicians
- •Whether liver metastases can be resected or not is determined by two or more attending physicians according to the Chinese guidelines for the diagnosis and comprehensive treatment of colorectal liver metastases
- •Patients with unresectable colorectal liver metastases after failed standard second-line therapy
- •Including, but not limited to, Oxaliplatin, Fluorouracil, and Irinotecan
- •Treatment failure is defined as disease progression and intolerable toxicity
- •Patients who withdrew from standard therapy due to unacceptable toxicity, guaranteed to discontinue treatment before disease progression and excluded treatment with the same drug, are also allowed to be included in the study.
- •At least one measurable lesion according to RECIST 1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •Subject life expectancy ≥12 weeks
- •Laboratory tests of bone marrow, hepatic and renal function and coagulation function within 7 days before the first dose of medication meet the study requirements
- •No blood transfusion, blood products, or correction with granulocyte colony-stimulating factor or other hematopoietic stimulating factor within 7 days before laboratory testing.
- •Female patients of childbearing age must have a negative blood pregnancy test within 7 days before the first dose of medication and male or female patients of childbearing age volunteered to take effective contraceptive measures during the whole treatment and within 3 months after treatment
- •All patients must sign an informed consent form and follow the trial treatment protocol and follow up plan
排除标准
- •ANC <1.5×109/L, or platelet count <80×109/L, or HGB < 9g/dL;
- •Blood transfusion to meet enrollment criteria within 2 weeks before enrollment is not allowed
- •serum total bilirubin>2.0 times upper limit of normal
- •AST and/or ALT>5.0 times upper limit of normal
- •Serum creatinine>1.5 times upper limit of normal, or creatinine clearance rate<50ml/min(calculated according to the Cockcroft-Gault formula)
- •APTT or PT>1.5 times upper limit of normal
- •Clinically significant severe electrolyte abnormalities by the investigator
- •Urine protein test 2+ or more, or 24 hours urine protein quantitation ≥1.0g/24h
- •Hypertension that is not stably controlled by medications: systolic blood pressure(SBP) >140mmHg or diastolic blood pressure(DBP) > 90mmHg
- •Patients with active gastric and duodenal ulcer, ulcerative colitis or other gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding or perforation as judged by the investigators; Or patients with previous gastrointestinal perforation or gastrointestinal fistula, which is not cured after surgical treatment
- •History of arterial or deep-vein thrombosis within 6 months before enrollment or evidence or history of bleeding tendency within 2 months before enrollment, regardless of severity
- •History of troke or transient ischemic attack within 12 months before enrollment
- •History of heart disease within 6 months before enrollment, manifested as congestive heart failure, acute myocardial infarction, severe/unstable angina, coronary artery bypass grafting; impaired cardiac function in NYHA class 2 or above; left ventricular ejection fraction (LVEF) <50%
- •Uncontrolled malignant pleural, ascites, or pericardial effusion
- •defined as not being effectively controlled with diuretics or punctures
- •Clinically detectable second primary malignancy or history of other malignancies within 5 years. Adequately treated nonmelanoma skin cancers, cervical carcinoma in situ, and superficial bladder tumors [noninvasive tumors, carcinoma in situ, and T1 (tumor invasion of the lamina propria)] are excluded
- •Central nervous system (CNS) metastases or previous brain metastases
- •Clinically uncontrolled severe active infection
- •Pregnant or lactating women or women of childbearing age have a positive pregnancy test before the first dose of medication; Or female participants themselves and their partners who are unwilling to use strict contraception during the trial
- •Patients are considered by the investigator to have any clinical or laboratory abnormalities or compliance issues that precluded participation in the trial
- •Serious psychological or psychiatric abnormalities
研究组 & 干预措施
HAIC combined with Tislelizumab and Regorafenib
Experimental
HAIC combined with Tislelizumab and Regorafenib until progression or death.
干预措施: Tislelizumab (Drug)
HAIC combined with Tislelizumab and Regorafenib
Experimental
HAIC combined with Tislelizumab and Regorafenib until progression or death.
干预措施: Regorafenib (Drug)
HAIC combined with Tislelizumab and Regorafenib
Experimental
HAIC combined with Tislelizumab and Regorafenib until progression or death.
干预措施: HAIC (Other)
结局指标
主要结局
Safety profiles by NCI-CTCAE version 5 .0
时间窗: From the first patient enrolled to 15 months after the last patient enrolled.
The evaluation of adverse events , using NCI-CTCAE version 5.0.
次要结局
- Disease control rate(DCR)(Up to 2 years)
- Response rate of extrahepatic lesions(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Overall response rate(ORR)(up to 2 years)
- Duration of Response (DoR)(Up to 2 years)
- Response rate of intrahepatic lesions(Up to 2 years)
- Quality of Life (QoL)(Up to 2 years)
- Progression free survival (PFS)(Up to 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
A Multi-center, Non-randomized, Open-label Phase II Clinical Study on the Treatment of Newly Diagnosed Advanced Hodgkin's Lymphoma With PD-1 Antibody (Tislelizumab) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CTChemotherapy EffectHodgkin LymphomaNCT04843267Sun Yat-sen University30
Unknown
1 期
Tislelizumab Plus TP as Neoadjuvant Therapy for Local Advanced Cervical CarcinomaCervical Squamous Cell CarcinomaNCT05013268Ruijin Hospital15
Unknown
1 期
Safety and Efficacy Study of Tislelizumab in Combination With BCG in HR-NMIBC Patients (TACBIN-01)Urinary Bladder NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsAntineoplastic AgentsUrinary Bladder DiseasesTislelizumab Antineoplastic Agents, ImmunologicalNCT04922047RenJi Hospital6
进行中（未招募）
1 期
Tislelizumab Combined with Mitoxantrone Hydrochloride Liposome in Extranodal Natural Killer/T Cell LymphomaExtranodal Natural Killer T Cell LymphomaNCT05464433Sun Yat-sen University46
招募中
2 期
Neoadjuvant Tislelizumab in Combination With Dasatinib and Quercetin in Resectable HNSCC (COIS-01)Head and Neck Squamous Cell CarcinomasNCT05724329Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University24