ChiCTR2300076280 版本V1.1 版本创建时间2024/03/07 12:27:35 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300076280 

最近更新日期：

Date of Last Refreshed on：

 2023-09-28 15:42:41 

注册时间：

Date of Registration：

 2023-09-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

复发性小肝癌SBRT对比微波消融临床疗效的随机对照研究

Public title：

A randomized controlled study of the clinical efficacy of SBRT versus microwave ablation for recurrent small hepatocellular carcinoma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

复发性小肝癌SBRT对比微波消融临床疗效的随机对照研究

Scientific title：

A randomized controlled study of the clinical efficacy of SBRT versus microwave ablation for recurrent small hepatocellular carcinoma

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

马子慧 

研究负责人：

郭卫星 

Applicant：

Zihui Ma 

Study leader：

Weixing Guo 

申请注册联系人电话：

Applicant telephone：

 +86 180 5228 8820

研究负责人电话：

Study leader's
telephone：

+86 139 1858 9919

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 731986584@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 weixingg88@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

上海市嘉定区墨玉北路700号

研究负责人通讯地址：

上海市嘉定区墨玉北路700号

Applicant address：

No.700,Moyu Road North, Jiading District, Shanghai, China

Study leader's address：

No.700,Moyu Road North, Jiading District, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

海军军医大学第三附属医院

Applicant's institution：

Third Affiliated Hospital of Naval Medical University

研究负责人所在单位：

海军军医大学第三附属医院

Affiliation of the Leader：

Third Affiliated Hospital of Naval Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 EHBHKY2022-H063-P001

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

海军军医大学第三附属医院伦理学委员会

Name of the ethic committee：

Clinical Research Ethics Committee of the Third Affiliated Hospital of Naval Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-02-27 00:00:00

伦理委员会联系人：

邰小云

Contact Name of the ethic committee：

Xiaoyun Tai

伦理委员会联系地址：

上海市杨浦区长海路225号

Contact Address of the ethic committee：

No.225,Changhai Road, Yangpu district, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 152 2139 0719

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

海军军医大学第三附属医院

Primary sponsor：

Third Affiliated Hospital of Naval Medical University

研究实施负责（组长）单位地址：

上海市嘉定区墨玉北路700号

Primary sponsor's address：

No.700,Moyu Road North, Jiading District, Shanghai, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

海军军医大学第三附属医院

具体地址：

上海市嘉定区墨玉北路700号

Institution
hospital：

Third Affiliated Hospital of Naval Medical University

Address：

No.700,Moyu Road North, Jiading District, Shanghai, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

肝癌  

Target disease：

liver cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

目前微波消融和SBRT是治疗复发性小肝癌的常规治疗治疗方式，二者均以创伤小为特点，但未有大样本研究对比两种治疗方式的临床疗效。本研究通过随机对照试验，SBRT对比微波消融治疗复发性小肝癌的临床疗效，以此制定规范的有效的复发性小肝癌的治疗方案。  

Objectives of Study：

Currently, microwave ablation and SBRT are conventional treatment modalities for recurrent small hepatocellular carcinoma, both of which are characterized by low trauma, but there is no large-sample study comparing the clinical efficacy of the two treatment modalities. In this study, a randomized controlled trial was conducted to compare the clinical efficacy of SBRT with that of microwave ablation in the treatment of recurrent small hepatocellular carcinoma, so as to formulate a standardized and effective therapeutic regimen for recurrent small hepatocellular carcinoma.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄在18岁至75岁之间，性别不限； 2.基于原发性肝癌的部分肝切除史和美国肝病研究协会的HCC诊断标准为复发性小肝癌; 3.R0切除原发性肿瘤，无肉眼可见的血管侵犯和肝外远处转移; 4.在初次肝切除术后的前2个月内未发现残余疾病; 5. RHCC单个直径≤3cm, 结节数量≤3个； 6.RHCC位于距相邻胃肠道、肝门、腔静脉或肝主静脉、胆囊和膈肌底部至少1.0 cm的位置，技术上可通过SBRT或经皮消融进行治疗。 7.肿瘤患者体力状态评分遵循东部肿瘤协作组织ECOGPS评分为0至1（0分正常活动；1分 症状轻，生活自在，能从事轻体力活动）； 8.肝功能分级Child-Pugh grade A或B; 9. 凝血酶原时（PT）小于正常对照4秒； 10. 无肝性脑病或/和中量以上腹水, 11.肾功能及心肺功能基本正常。 12.胃镜食道静脉无重度曲张、无活动性消化道溃疡者。 13.血红蛋白≥90g/L，白细胞计数≥3.0×109/L、中性粒细胞计数≥1.5×109/L、血小板计数≥40×109/L; 14.无明确恶病质表现； 15.预计寿命大于三个月，无妊娠，无HIV或梅毒感染； 16.能理解本研究的情况并已签署知情同意书者。

Inclusion criteria

1. between the ages of 18 and 75 years, and of either sex 2. recurrent small hepatocellular carcinoma based on a history of partial hepatectomy for primary hepatocellular carcinoma and the American Association for the Study of Liver Diseases diagnostic criteria for HCC; and 3. R0 resection of the primary tumor without visible vascular invasion and extrahepatic distant metastases; and 4. no residual disease detected within the first 2 months after initial hepatectomy; and 5. RHCC with a single diameter of ≤3cm and the number of nodules ≤3; 6. The RHCC is located at least 1.0 cm from the adjacent gastrointestinal tract, hepatic hilum, vena cava or main hepatic vein, gallbladder, and the base of the diaphragm, and is technically amenable to treatment by SBRT or percutaneous ablation. 7. The physical status score of tumor patients follows the Eastern Cooperative Oncology Group ECOGPS score of 0 to 1 (0 for normal activity; 1 for mild symptoms, comfortable with life, and able to engage in light physical activity); 8. liver function grade Child-Pugh grade A or B; and 9. prothrombin time (PT) less than 4 seconds from normal control; 10. absence of hepatic encephalopathy or/and ascites of more than moderate volume. 11. Renal function and cardiopulmonary function are essentially normal. 12. Gastroscopy of esophageal veins without severe varices, no active peptic ulcers 13. Hemoglobin ≥90g/L, white blood cell count ≥3.0×109/L, neutrophil count ≥1.5×109/L, platelet count ≥40×109/L. 14. No clear manifestation of malignant disease; 15. expected life expectancy greater than three months, no pregnancy, and no HIV or syphilis infection; 16. those who can understand the circumstances of this study and have signed the informed consent form.

排除标准：

（1） 入选前5年内有其他恶性肿瘤病史； （2） 通过术前增强腹部CT和内镜诊断的门静脉高压，有食管静脉曲张出血、严重脾功能亢进综合征或难治性腹水病史； （3）入选前任何抗RHCC治疗史，包括经导管动脉化疗栓塞、射频消融、放疗和化疗； （4）自发性肿瘤破裂史； （5）术后病理提示转移性癌症或其他组织类型的原发性癌症； （6）入选前6个月内有脑血管意外史； （7）过去6年内有不稳定心绞痛、心肌梗死或心力衰竭病史纳入前数月； （8）入选前4周内其他疾病的外科治疗史； （9） 严重肺部疾病（如肺纤维化、严重肺气肿、肺心病）；或1秒用力呼气量（FEV1）<预测值的50%，或动脉O2≤60mmHg或动脉CO2＞50mmHg； （10）血清肌酐>1.25倍正常上限； （11）急性或活动性感染控制不佳（感染引起的发热>38℃）； （12）高血压或糖尿病控制不佳； （13）严重的精神疾病或障碍； （14）影像学研究显示的可疑全身或局部淋巴结病； （15）接受皮质类固醇的系统给药； （16）其他疾病的伴随手术治疗要求； （17）怀孕或哺乳期妇女； （18）其他严重的潜在疾病； （19）无法或拒绝遵守规则 （20）参与其他临床试验； （21）拒绝提供知情同意 关键的排除标准是过去5年内有其他恶性肿瘤病史、自发性肿瘤破裂史、既往抗RHCC治疗史、严重伴发疾病、急性或活动性传染病、怀孕或哺乳史。

Exclusion criteria：

(1) History of other malignant tumors within 5 years prior to enrollment; (2) Portal hypertension diagnosed by preoperative enhanced abdominal CT and endoscopy, history of esophageal variceal bleeding, severe hypersplenism syndrome, or refractory ascites; (3) History of any anti-RHCC therapy prior to enrollment, including transcatheter arterial chemoembolization, radiofrequency ablation, radiotherapy, and chemotherapy; (4) History of spontaneous tumor rupture; (5) Postoperative pathology suggestive of metastatic cancer or primary cancer in other tissue types; (6) History of cerebrovascular accident within 6 months prior to enrollment; (7) History of unstable angina, myocardial infarction, or heart failure within the past 6 years months prior to inclusion; (8) History of surgical treatment for other diseases within 4 weeks prior to enrollment; (9) Severe lung disease (e.g., pulmonary fibrosis, severe emphysema, pulmonary heart disease); or a forced expiratory volume in 1 second (FEV1) <50% of predicted, or an arterial O2 ≤60 mmHg or an arterial CO2 >50 mmHg; (10) Serum creatinine > 1.25 times the upper limit of normal; (11) Poorly controlled acute or active infection (infection-induced fever >38°C); (12) Poorly controlled hypertension or diabetes mellitus; (13) Severe mental illness or disorder; (14) Suspected systemic or localized lymphadenopathy on imaging studies; (15) Receipt of systemic administration of corticosteroids; (16) Requirement for concomitant surgical treatment of other diseases; (17) Pregnant or lactating women; (18) Other serious underlying medical conditions; (19) Inability or refusal to comply with the rules (20) Participation in other clinical trials (21) Refusal to provide informed consent Key exclusion criteria were history of other malignancies within the past 5 years, history of spontaneous tumor rupture, history of prior anti-RHCC therapy, serious concomitant disease, acute or active infectious disease, pregnancy, or lactation.

研究实施时间：

Study execute time：

从 From 2023-10-01 00:00:00至 To 2025-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-10-01 00:00:00 至 To 2025-09-01 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 50

Group：

Trial group

Sample size：

干预措施：

患者入组后进行微波消融治疗

干预措施代码：

Intervention：

patients underwent microwave ablation after enrollment

Intervention code：

组别：

对照组

样本量：

 50

Group：

Control group

Sample size：

干预措施：

患者入组后进行SBRT治疗

干预措施代码：

Intervention：

patients were treated with SBRT after enrollment

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海市 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 海军军医大学第三附属医院 

单位级别：

 三甲 

Institution
hospital：

The Third Affiliated Hospital of Naval Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

总体生存期

指标类型：

主要指标

Outcome：

Overall survival

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无病生存期

指标类型：

次要指标

Outcome：

Disease-free survival

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

患者按1:1的比例随机接受PMWA或SBRT。随机分组开始前，研究团队外数据中心的一名工作人员根据RHCC的大小（≤3cm）和数量（单个或多个）生成基于计算机的随机序列，然后将其放入顺序编号的不透明密封信封中。在获得符合条件的患者的书面知情同意后，向数据中心打一个电话，工作人员打开了一个依次放置的信封，并将患者的分组告知了调查人员。对患者和医生进行分组分配。进行统计分析的工作人员不被告知分组的干预措施。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Patients were randomized to receive either PMWA or SBRT in a 1:1 ratio.Prior to the start of the randomization grouping, a staff member at the data center outside of the study team generated computer-based random sequences based on the size (≤3 cm) and number of RHCCs (single or multiple), which were then placed in sequentially numbered, opaque, sealed envelopes. After obtaining written informed consent from eligible patients, a phone call was made to the data center, and a staff member opened a sequentially placed envelope and informed the investigator of the grouping of patients. Groupings of patients and physicians were assigned. Staff performing the statistical analysis were not informed of the subgroup interventions.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

none

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

通过ResMan平台公开原始数据，数据公开日期为试验完成分析统计，撰写文章完成后

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Disclosure of raw data via the ResMan platform, data disclosure date is the trial completion analysis statistics, after the article has been written

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

采用病例记录表方式完成原始数据采集和管理，至研究完成后数据公开时录入ResMan平台管理

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Raw data collection and management is completed using CRF form and entered into the ResMan platform for management when the data is made public after the study

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-09-28 15:42:21