NCT05412589招募中2 期
Intravenous mFOLFOX7 Plus Camrelizumab and Apatinib for CNLC Stage III Hepatocellular Carcinoma
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年6月10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
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a prospective, one-arm, phase II clinical study of intravenous mFOLFOX6 plus Camrelizumab combined with apatinib for CNLC stage III hepatocellular carcinoma
详细描述
The combination of anti-angiogenesis and immune checkpoint blockade showed promising outcomes for advanced HCC. Hepatic artery infusion chemotherapy （HAIC） combined with apatinib and camrelizumab could augment treatment efficacy in preliminary study. But HAIC had disadvantages such as technical limitations, expensive cost and poor patient comfort. In the present study, we aimed to investigate the efficacy and safety of Venous Infusion Chemotherapy（VIC） plus camrelizumab and apatinib for CNLC stage Ⅲ HCC.
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
- •Patients volunteered to participate in this study and signed informed consent;
- •Age 18-75, male or female;
- •ECOG PS score 0-2;
- •Child-pugh liver function grading: Grade A or B
- •The clinical diagnosis conforms to primary hepatocellular carcinoma (HCC) and the lesion conforms to stage III according to China liver cancer staging (CNLC)
- •Did not received any type of other first-line drugs such as Sorafenib
- •According to RECIST 1.1 standard, patients have at least one measurable lesion (CT/MRI scan long diameter ≥10mm or CT/MRI scan short diameter ≥15mm for lymph node lesions, and the lesion has not received radiotherapy, freezing or other local treatments);
- •Expected survival ≥ 12 weeks;
- •The function of vital organs meets the following requirements (excluding the use of any blood component and cell growth factor within 14 days) :
- •Blood routine:
- •White blood cells count ≥3.0×109/L Platelet count ≥70×109/L Hemoglobin ≥80g/L;
- •Liver and kidney function:
- •Serum creatinine (SCr) ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥50 ml/min (Cockcroft-Gault formula); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); AST or ALT levels ≤ 3 times the upper limit of normal value (ULN)
- •Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during and within six months of the end of medication;Patients with negative serum or urine pregnancy tests within 7 days prior to study inclusion and who must be non-lactating, and males should agree to use contraceptives during the study period and for 6 months after the end of the study period.
- •Subjects have good compliance and cooperate with the follow-up.
- •Subjects with HBV or HCV infection should receive anti-virus treatment without interfron.
排除标准
- •Have received immunotherapeutic drugs or interferon in the past.
- •Severe allergic reaction to other monoclonal antibodies.
- •Female subjects with pregnancy.
- •Patients with congenital or acquired immune deficiencies.
- •Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin
- •The patient has suffered from other malignant tumors at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)
- •The patient has active infection, fever of unknown origin within 7 days (CTCAE>2)
- •Patients with congenital or acquired immune deficiencies.
- •With clinical symptoms or diseases of the heart that are not well controlled.
- •According to the judgment of the investigator, the patients with factors that may affect the results of the study or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) need to be treated together, severe laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients
研究组 & 干预措施
intravenous mFOLFOX7 combined with Camrelizumab and apatinib
Experimental
Combination of systemic chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (mFOLFOX7) , targeted drugs (Apatinib 250mg), and anti-PD-1 immunotherapy (Camrelizumab 200mg)
干预措施: mFOLFOX7+Camrelizumab+Apatinib (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
The Objective Response Rate(ORR) is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1.
次要结局
- mORR(1 year)
- DOR(1 year)
- conversion rate(1 year)
- DCR(1 year)
- PFS(1 year)
- TRAE(1 year)
- OS(1 year)
研究者
研究点 (1)
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