NCT03881501Unknown不适用
A Single Arm, Observational Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment With Sintilimab Injection Plus Endostar in Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
It is a a single arm, observational clinical trial to evaluate the efficacy and safety of combination treatment with sintilimab injection plus endostar in untreated locally advanced or metastatic hepatocellular carcinoma.
详细描述
For the first line treatment with untreated locally advanced or metastatic hepatocellular carcinoma, sintilimab injection plus endostar might be one of the treatment choices.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Able and willing to comply with the study plans in this protocol and sign the informed consent;
- •Age of 18-75 years;
- •Cytological or histological diagnosis of untreated locally advanced or metastatic hepatocellular carcinoma;
- •Diseases are not suitable for radical surgery and/or local treatment, or disease progression occurs after surgery and/or local treatment;
- •At least one measurable lesion as defined by RECIST 1.1 criteria and untreated lesion;
- •Patients who have received previous local treatment (e.g., radiofrequency ablation, ethanol or acetic acid injection, cryoablation, high intensity focused ultrasound, transcatheter arterial chemoembolization, transcatheter arterial embolization, etc.) are eligible to participate in the study if the target lesion has not received local treatment before, or if the target lesion within the scope of local treatment has subsequently developed on the basis of RECIST v1.1;
- •ECOG performance status of 0-1;
- •Child-Pugh A;
- •Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥75×109 /L, hemoglobin(HB) ≥90 g/L;
- •alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤5 x upper limit of normal range (ULN);total bilirubin (TBIL)≤3 x upper limit of normal range (ULN);Creatinine(Cr)≤1.5 x upper limit of normal range(ULN);Serum albumin (> 28 g/L) (2.8 g/dL);Patients not receiving anticoagulation therapy: INR or aPTT < 2 *ULN;Urinary cellulose test paper results Proteinuria < 2 (7 days before the start of treatment);Patients with baseline cellulose test paper urine test results (> 2 proteinuria) should collect 24-hour urine, and then must confirm that the 24-hour urinary protein content is less than 1 g;
- •HIV test results were negative at screening;
- •Records of virological status of hepatitis, confirmed by serological tests of HBV and HCV;
- •Patients with active hepatitis B virus (HBV) infection:HBV DNA < 500 IU/mL was obtained within 28 days before the start of the study, and received at least 14 days of anti-HBV treatment (based on local standard treatment, such as entecavir) prior to the study, and was willing to continue treatment during the study period.
排除标准
- •Systemic HCC treatment has been received in the past;
- •History of primary immunodeficiency is known;
- •It is known to have active tuberculosis;
- •History of allogeneic organ transplantation and hematopoietic stem cell transplantation is known;
- •It is known that there is a history of human immunodeficiency virus (HIV) infection (that is, HIV antibody positive);
- •Severe allergic/allergic reactions to humanized antibodies or fusion proteins were observed;
- •It is known to have hypersensitivity to any component contained in Endor preparations;
- •Initial serious heart disease patients include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease and refractory hypertension;
- •History of PIA meningitis;
- •Major cardiovascular diseases (e.g. New York Heart Association Grade II or more serious heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris, occurred within three months before the start of treatment;
- •Major surgical treatments (except diagnosis) were received within 4 weeks before the start of the study, or major surgical treatments were expected during the study period;
- •Other malignant tumors were diagnosed within 5 years before the first administration. Exceptions included radical basal cell carcinoma, squamous cell carcinoma, adequately treated cervical cancer in situ, and localized prostate cancer;
- •Active infections requiring systemic treatment;
- •Fiberboard HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC are known;
- •Moderate or severe ascites;
- •History of hepatic encephalopathy;
- •Patients with a history of HCV infection but negative results of HCV RNA PCR may consider that they are not infected with HCV;
- •Systemic glucocorticoid therapy or any other form of immunosuppressive therapy is being administered within 7 days prior to the diagnosis of immunodeficiency or the study's first administration; physiological doses of glucocorticoid (<10mg/day prednisone or equivalent) are allowed.
结局指标
主要结局
PFS
时间窗: up to 3 years
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
ORR
时间窗: up to 3 years
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
次要结局
- OS(up to 3 years)
- Safety as measured by number and grade of adverse events(up to 3 years)
- DOR(up to 3 years)
研究者
Xianglin Yuan
Professor, Head of the cancer center
Huazhong University of Science and Technology
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
The Combination Therapy of TACE and Ablation With Durvalumab in Hepatocellular Carcinoma at Intermediate Stage (TAD)Hepatocellular CarcinomaNCT04517227Fudan University30
招募中
不适用
A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery StenosisPulmonary Artery StenosisNCT04973540Biotyx Medical (Shenzhen) Co., Ltd.82
尚未招募
2 期
Fluzopari Combined With Apatinib for the Neoadjuvant Treatment of Unresectable Ovarian CancerOvarian CancerNCT05597527Fujian Cancer Hospital35
暂停
早期 1 期
Universal CAR-T Cells (REVO-UWD-00B) for Refractory and Relapsed Multiple MyelomaMultiple MyleomaRefractory and Relapsed Multiple MyelomaNCT06663046Wondercel Biotech (ShenZhen)30
Enrolling By Invitation
2 期
the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With TrilaciclibNon-small Cell Lung CancerNCT06370416Henan Cancer Hospital41