ChiCTR2600122377 版本V1.0 版本创建时间2026/04/13 14:56:51 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：

 ChiCTR2600122377 

最近更新日期：

Date of Last Refreshed on：

 2026-04-13 14:56:28 

注册时间：

Date of Registration：

 2026-04-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

个体化周期性放疗联合PD-1单抗治疗晚期实体瘤观察性研究

Public title：

Observational Study on the Treatment of Advanced Solid Tumors with heterogeneous onion periodical extended radiotherapy（HOPE-RT）Combined with PD-1 Monoclonal Antibody

注册题目简写：

English Acronym：

研究课题的正式科学名称：

个体化周期性放疗联合PD-1单抗治疗晚期实体瘤观察性研究

Scientific title：

Observational Study on the Treatment of Advanced Solid Tumors with heterogeneous onion periodical extended radiotherapy（HOPE-RT）Combined with PD-1 Monoclonal Antibody

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：

闫婧 

研究负责人：

闫婧 

Applicant：

Yan Jing 

Study leader：

Yan Jing 

申请注册联系人电话：

Applicant telephone：

 +86 15805182426

研究负责人电话：

Study leader's
telephone：

+86 25 86617141

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：

 yj20030610@yeah.net

研究负责人电子邮件：

Study leader's E-mail：

 yj20030610@yeah.net

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：

江苏省南京市汉中路155号

研究负责人通讯地址：

江苏省南京市汉中路155号

Applicant address：

No. 155 Hanzhong Road, Nanjing, Jiangsu Province

Study leader's address：

No. 155 Hanzhong Road, Nanjing, Jiangsu Province

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：

江苏省中医院

Applicant's institution：

JiangSu Province Hospital of Chinese Medicine

研究负责人所在单位：

江苏省中医院

Affiliation of the Leader：

Jiangsu Province Hospital of Chinese Medicine

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：

 2026NL-070-02

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：

南京中医药大学附属医院（江苏省中医院）伦理委员会

Name of the ethic committee：

Ethics Committee of Nanjing University of Traditional Chinese Medicine Affiliated Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-18 00:00:00

伦理委员会联系人：

王卯

Contact Name of the ethic committee：

Wang Mao

伦理委员会联系地址：

江苏省南京市汉中路155号

Contact Address of the ethic committee：

No. 155 Hanzhong Road, Nanjing, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 25 86560515

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 llwyhbgs@qq.com

研究实施负责（组长）单位：

江苏省中医院

Primary sponsor：

Jiangsu Province Hospital of Chinese Medicine

研究实施负责（组长）单位地址：

江苏省南京市汉中路155号

Primary sponsor's address：

No. 155 Hanzhong Road, Nanjing, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

江苏省中医院

具体地址：

江苏省南京市汉中路155号

Institution
hospital：

Jiangsu Province Hospital of Chinese Medicine

Address：

No. 155 Hanzhong Road, Nanjing, Jiangsu Province

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

实体瘤（包括肺癌、肝癌、食管癌、胃癌、鼻咽癌、尿路上皮癌、其他MSI-H/dMMR实体瘤）  

Target disease：

Solid tumors (including lung cancer, liver cancer, esophageal cancer, stomach cancer, nasopharyngeal cancer, urothelial carcinoma, and other MSI-H/dMMR solid tumors)

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

主要目的： 评价个体化周期性放疗（heterogeneous onion periodical extended radiotherapy，HOPE-RT）联合PD-1单抗治疗晚期实体瘤的有效性和安全性。 次要目的： 评价个体化免疫性放疗联合PD-1单抗治疗晚期实体瘤的客观缓解率（ORR）、安全性、6个月无进展生存率（PFS）、总生存期（OS）。  

Objectives of Study：

Primary objective:To evaluate the efficacy and safety of individualized periodic radiotherapy (heterogeneous onion periodical extended radiotherapy, HOPE-RT) combined with PD-1 monoclonal antibody in the treatment of advanced solid tumors. Secondary objective:To evaluate the objective response rate (ORR), safety, 6-month progression-free survival rate (PFS), and overall survival (OS) of individualized immunotherapy combined with PD-1 monoclonal antibody in the treatment of advanced solid tumors.

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≥18岁（签署知情同意书当天）； 2.知情同意且签署书面知情同意书； 3.经病理组织学或细胞学确诊的实体瘤患者，包括肺癌、肝癌、食管癌、胃癌、鼻咽癌、尿路上皮癌、其他MSI-H/dMMR实体瘤，且：(1)局部治疗方法不能治愈；(2)至少经一线系统治疗后的复发/转移患者（靶向、免疫和/或化疗）；(3)签署知情同意书时局晚期系统治疗结束6个月以上；(4)无其他部位的原发癌； 4.预计生存期超过6个月； 5.至少存在1个及以上具有RECIST1.1标准的可测量病灶； 6.美国东部肿瘤协作组体力状态评分（Eastern Cooperative Oncology Group Performance Status,ECOGPS）0∽3分； 7.具有足够的器官功能：； 8.可提供肿瘤组织进行PD-L1检测（既往已检测过则不必再追加）； 9.允许接受过一种免疫检查点抑制剂或ADC药物治疗者； 10.首次给药前72h内妊娠试验阴性； 11.育龄期女性愿意在研究开始至最后一剂药物给药后180天中，采取2种避孕措施或手术绝育，或不进行性生活。育龄期女性指的是：没有进行手术绝育，或未停经1年以上； 12.男性受试者需在研究开始至最后一剂药物给药后180天中，采取足够的避孕措施。 13.知情同意，志愿受试。获得知情同意书过程应符合 GCP 规定。

Inclusion criteria

1.Male/female participants who are at least 18 years of age on the day of signing informed consent; 2.The participant must provide (or legally acceptable representative if applicable) written informed consent for the trial; 3.Histologically confirmed diagnosis of solid tumors, including of lung cancer,HCC,esophageal cancer, gastric cancer,nasopharyngeal cancer, urothelial carcinoma and other MSI-H/dMMR solid tumors,which is all of the following conditions applies:(1) Local treatment methods cannot cure the disease;(2) Patients with recurrence or metastasis after at least one line of systemic treatment (targeted, immunological and/or chemotherapy); (3) More than 6 months have passed since the end of advanced systemic treatment when signing the informed consent form;(4) No primary cancer in other parts; 4.The estimated survival period is more than 6 months; 5.There must be at least one or more measurable lesions that meet the RECIST 1.1 criteria; 6.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3; 7.Have adequate organ function as defined in the following table; 8.Have provided archival tumor tissues which can be provided for PD-L1 testing (if previously tested, no additional testing is required) 9.The anticipant can be allowed to have received treatment with an immune checkpoint inhibitor or an ADC drug; 10.A female participant is eligible to participate if she is not pregnant; 11. Women of childbearing age are willing to adopt two contraceptive measures, or undergo surgical sterilization, or refrain from sexual activity from the beginning of the study until 180 days after the last dose of medication is administered. Women of childbearing age are defined as those who have not undergone surgical sterilization or have not experienced menopause for more than one year; 12.A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days; 13. Informed consent, voluntary participation. The process of obtaining informed consent should comply with GCP regulations.

排除标准：

1.转移灶可通过局部治疗治愈的； 2.ECOG评分>3分； 3.入组前2周内进行过靶病灶放疗或其他局部治疗（如手术），或未从既往治疗的不良事件中恢复（如≤1级，或恢复至基线）。 但是以下情况可除外： 神经毒性≤2级，脱发≤2级，或实验室检查如入选标准第（7）条者。 4.入组前4周内参加过临床试验（处于随访期，未接受治疗者除外）； 5.快速进展的肿瘤（如肿瘤出血、无法控制的肿瘤疼痛等）； 6.入组前7天内被诊断免疫缺陷病或存在自身免疫性疾病风险，或在接受全身性的激素治疗，或在接受其他形式的免疫抑制治疗。使用造影剂、或因处理AE等需激素治疗除外。生理水平剂量糖皮质激素的使用可由研究者决定； 7.入组前5年诊断过其他恶性肿瘤，但下列情况除外：已治愈的皮肤基底细胞癌、皮肤鳞状细胞癌、原位宫颈癌、原位乳腺癌，或其他研究者认为可除外的已治愈肿瘤； 8.中枢神经系统转移者；无法控制的癫痫者； 9.接受异种基因组织移植或实质器官移植； 10.具需要激素治疗的非感染性肺炎病史或肺炎现病史； 11.需要系统性治疗的活动性感染； 12.经研究者评估，存在影响受试者安全或影响试验评价的病史等其他因素； 13.存在影响试验依从性或配合的精神疾病或药物滥用情况； 14.怀孕或哺乳期妇女，或在试验筛选期开始至末次给药180天内有生育打算； 15.既往接受过2种或2种以上免疫检查点抑制剂或ADC药物治疗者； 16.血清病毒学检查HIV阳性，或有HIV感染病史； 17.活动性的HBV或HCV； 18.试验开始前30天内接受过活疫苗。 19. 入组前 2 年内患有需要系统性治疗的活动性免疫性疾病（如使用病情缓解药，糖皮质激素，或免疫抑制剂），或存在自身免疫性疾病风险者（如抗核抗体阳性者）。但是替代疗法如甲状腺素，胰岛素，因肾上腺或垂体功能不全使用生理剂量的糖皮质激素等除外；

Exclusion criteria：

1.The metastatic lesions can be cured through local treatment; 2.Have an Eastern Cooperative Oncology Group (ECOG) performance status is greater than 3; 3.The patient has undergone radiotherapy to the target lesion or other local treatment (such as surgery) within 2 weeks prior to enrollment, ,or has not recovered from adverse events from previous treatments (such as <= grade 1, or returning to baseline). However, the following situations can be excluded: neurotoxicity <= grade 2, alopecia <= grade 2, or laboratory tests as specified in item (7) of the inclusion criteria; 4.Has participated in a clinical trial within the 4 weeks prior to enrollment(excluding those who were in the follow-up period and had not received any treatment); 5.Rapidly progressing tumors (such as tumor bleeding, uncontrollable tumor pain, etc.); 6.Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 7.Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) or other solid tumor or hematologic malignancy that have undergone potentially curative therapy; 8.Has known active CNS metastases and/or uncontrolled seizure; 9.Has Accepted transplants of foreign genetic tissues or actual organs; 10.Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; 11.Has an active infection requiring systemic therapy; 12.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator; 13.Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial; 14.Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment; 15.Has previously received treatment with two or more types of immune checkpoint inhibitors or ADC drugs; 16.Has a known history of Human Immunodeficiency Virus (HIV) testing is not required unless mandated by local health authority; 17.Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA) infection; 18. Has received live vaccines within 30 days prior to the experiment; 19. Patients with active immune diseases requiring systemic treatment (such as the use of remission drugs, glucocorticoids, or immunosuppressants) or at risk of autoimmune diseases (such as antinuclear antibody positive) within 2 years before enrollment. However, replacement therapy such as thyroxine, insulin, and the use of physiological doses of glucocorticoids due to adrenal or pituitary insufficiency are excluded;

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2029-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-04-13 00:00:00 至 To 2028-04-12 00:00:00

干预措施：

Interventions：

组别：

观察组

样本量：

 49

Group：

Observation group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 江苏省中医院 

单位级别：

 三级甲等 

Institution
hospital：

Jiangsu Province Hospital of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肿瘤客观缓解率

指标类型：

主要指标

Outcome：

Objective Response Rate

Type：

Primary indicator

测量时间点：

入组后9周

测量方法：

RECIST 1.1

Measure time point of outcome：

9 weeks after enrollment

Measure method：

RECIST 1.1

指标中文名：

6个月无进展生存率（PFS）

指标类型：

次要指标

Outcome：

6-month Progression-free survival rate

Type：

Secondary indicator

测量时间点：

入组后6个月

测量方法：

RECIST 1.1

Measure time point of outcome：

6 months after enrollment

Measure method：

RECIST 1.1

指标中文名：

总生存期

指标类型：

次要指标

Outcome：

Overall survival

Type：

Secondary indicator

测量时间点：

死亡

测量方法：

随访

Measure time point of outcome：

Death

Measure method：

follow-up

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

每次治疗后

测量方法：

EORTC QLQ-C30 (V3)和EORTC QLQ-H&N35

Measure time point of outcome：

After every treatment

Measure method：

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (Version 3.0) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Head and Neck 35

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织样本

组织：

Sample Name：

Tumor tissue

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

血

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：

尚未开始

Not yet recruiting

年龄范围：

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

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

否No

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）：

无

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

None

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：

CRF和EDC

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

CRF and EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-13 14:56:28