中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600123414
最近更新日期： Date of Last Refreshed on：	2026-04-26 22:04:54
注册时间： Date of Registration：	2026-04-26 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	氟唑帕利联合法米替尼用于PARPi维持治疗中生化复发卵巢癌患者的有效性、安全性临床研究
Public title：	Efficacy and safety of Fuzuloparib Combined with Famitinib for biochemical recurrence in ovarian cancer patients receiving PARPi maintenance therapy
注册题目简写：
English Acronym：
研究课题的正式科学名称：	氟唑帕利联合法米替尼用于PARPi维持治疗中生化复发卵巢癌患者的有效性、安全性临床研究
Scientific title：	Efficacy and Safety of Fuzuloparib Combined with Famitinib in Patients with Biochemical Recurrence of Ovarian Cancer Following PARPi Maintenance Therapy: A Clinical Study
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：	刘文欣	研究负责人：	刘文欣
Applicant：	Wenxin Liu	Study leader：	Wenxin Liiu
申请注册联系人电话： Applicant telephone：	+86 186 2222 1101	研究负责人电话： Study leader's telephone：	+86 186 2222 1101
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：	wenxin1973@163.com	研究负责人电子邮件： Study leader's E-mail：	wenxin1973@163.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：	天津市河西区体院北环湖西路(天津市肿瘤医院)	研究负责人通讯地址：	天津市河西区体院北环湖西路(天津市肿瘤医院)
Applicant address：	Huanhu West Road, Tiyuanbei, Hexi District, Tianjin (Tianjin Medical University Cancer Institute & Hospital)	Study leader's address：	Huanhu West Road, Tiyuanbei, Hexi District, Tianjin (Tianjin Medical University Cancer Institute & Hospital)
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：	天津市肿瘤医院
Applicant's institution：	Tianjin Medical University Cancer Institute & Hospital
研究负责人所在单位：	天津市肿瘤医院
Affiliation of the Leader：	Tianjin Medical University Cancer Institute & Hospital

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：	E20260170	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：	天津市肿瘤医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Tianjin Medical University Cancer Institute & Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2026-02-06 00:00:00
伦理委员会联系人：	刘美君
Contact Name of the ethic committee：	Meijun Liu
伦理委员会联系地址：	天津市河西区环湖西路肿瘤医院科创中心三楼伦理办公室
Contact Address of the ethic committee：	Ethics Office, 3rd Floor, Innovation Center, Tumor Hospital, Huanhu West Road, Hexi District, Tianjin
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 22 2334 0123	伦理委员会联系人邮箱： Contact email of the ethic committee：	ec_tjcih@126.com

研究实施负责（组长）单位：

天津市肿瘤医院

Primary sponsor：

Tianjin Medical University Cancer Institute & Hospital

研究实施负责（组长）单位地址：

天津市河西区体院北环湖西路(天津市肿瘤医院)

Primary sponsor's address：

Huanhu West Road, Tiyuanbei, Hexi District, Tianjin (Tianjin Medical University Cancer Institute & Hospital)

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	天津	市(区县)：
Country：	China	Province：	Tianjin	City：
单位(医院)：	天津市肿瘤医院	具体地址：	天津市河西区体院北环湖西路(天津市肿瘤医院)
Institution hospital：	Tianjin Medical University Cancer Institute & Hospital	Address：	Huanhu West Road, Tiyuanbei, Hexi District, Tianjin (Tianjin Medical University Cancer Institute & Hospital)

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

卵巢癌

Target disease：

Ovarian 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：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

评估氟唑帕利联合法米替尼用于治疗PARPi维持治疗过程中生化复发卵巢癌患者的有效性。

Objectives of Study：

To evaluate the efficacy of fuzuloparib combined with famitinib in patients with biochemical recurrence of ovarian cancer during PARPi maintenance therapy.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Voluntary participation and signed informed consent;
2. Age between 18 and 70 years;
3. Histopathologically confirmed malignant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
4. Achievement of no evidence of disease (NED) or complete response/partial response (CR/PR) after the last platinum-based chemotherapy;
5. Prior maintenance therapy with a PARP inhibitor as a single agent;
6. CA125 level >= 2 times the upper limit of normal (ULN) or >= 2 times the patient's nadir value (for patients whose CA125 was not elevated prior to treatment or had returned to normal after initial treatment, elevation is defined as >= 2× ULN; for patients with elevated CA125 at initial diagnosis that did not normalize after treatment, elevation is defined as >= 2× the nadir value), with no evidence of tumor recurrence on imaging;
7. Life expectancy >= 3 months;
8. Adequate major organ function, with results from tests performed within 7 days prior to the first dose meeting the following criteria:
   1) Hematology (without blood transfusion or use of hematopoietic growth factors within 7 days prior to screening): Hemoglobin (Hb) >= 90 g/L; absolute neutrophil count (ANC) >= 1.5×10⁹/L; lymphocyte count (LC) >= 0.5×10⁹/L; platelet count (PLT) >= 75×10⁹/L; white blood cell count (WBC) >= 3.0×10⁹/L and <= 15×10⁹/L;
   2) Serum biochemistry (without blood transfusion or albumin infusion within 7 days prior to screening): Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5× ULN; alkaline phosphatase (ALP) <= 2.5× ULN; total bilirubin (TBIL) <= 1.5× ULN; serum creatinine (Cr) <= 1.5× ULN, and creatinine clearance (CrCL) >= 60 mL/min (Cockcroft-Gault formula); prothrombin time (PT) and activated partial thromboplastin time (APTT) <= 1.5× ULN, and international normalized ratio (INR) <= 1.5× ULN (in patients not receiving anticoagulation);
   3) Urinalysis: Urine protein < 2+; if urine protein >= 2+, 24-hour urine protein quantification must show protein <= 1 g;
   4) Thyroid function: Thyroid-stimulating hormone (TSH) within normal range, or abnormal but with normal free T3 (FT3)/free T4 (FT4) levels and asymptomatic (stable doses of thyroid hormone replacement therapy permitted);
   5) 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 470 ms in females.
9. Wound healing: At least 4 weeks have passed since the last major surgery (e.g., laparotomy, thoracotomy), and the wound is fully healed.
10. The subject voluntarily agrees to participate in this study, signs the informed consent form, demonstrates good compliance, and is able to cooperate with follow-up.

排除标准：

1.患有其他恶性肿瘤的患者（除外已完全治疗且无疾病证据的原位癌患者、已完成根治性治疗的甲状腺癌患者，以及已完成根治性治疗且距末次肿瘤相关治疗筛选时间超过 5 年的其他恶性肿瘤患者）； 2.影像学评估显示明确的肿瘤复发或进展证据； 3.重要器官移植史； 4.严重精神疾病史或脑功能障碍史；药物滥用史或吸毒史； 5.任何活动性自身免疫性疾病或自身免疫性疾病史（包括但不限于自身免疫性肝炎、间质性肺炎、肝炎、肠炎、肾炎、垂体炎、血管炎、葡萄膜炎），或需要全身性激素治疗和/或免疫抑制治疗的患者（如需要使用支气管扩张剂的哮喘）；以下情况除外：白癜风、脱发、Graves综合征、过去 2 年内无需系统治疗的银屑病或湿疹、治疗后已控制的稳定免疫性甲状腺炎、仅需稳定胰岛素治疗的 I 型糖尿病、儿童期哮喘已完全缓解； 6.正在使用免疫抑制剂或全身性激素以达到免疫抑制目的（剂量 > 10mg/天的泼尼松或其他等效激素制剂），且在入组前 2 周内仍在使用。允许局部和全身使用剂量不超过 10mg/天的泼尼松或其他等效激素制剂； 7.活动性出血（肿瘤引起的出血需研究者评估）、出血倾向或有大出血风险的患者（如肿瘤累及大血管、重要支气管，止血治疗后仍明显无法控制的出血，未治愈的支气管扩张症），或肿瘤影像学评估显示侵犯主要血管（如颈动脉、肺动脉、大支气管旁血管等），或需要同时使用香豆素抗凝剂治疗的患者；筛选前 3 个月内有 >= 2.5 mL 的鲜红色咯血史。 8.过去 6 个月内发生过血栓或栓塞事件，如脑血管意外（包括短暂性脑缺血发作）； 9.严重的心血管疾病或病史包括但不限于以下：入组前 6 个月内出现 NYHA 3 级和 4 级充血性心力衰竭；筛选前 12 个月内出现不稳定型心绞痛或新诊断的心绞痛或心肌梗塞；需要治疗干预的心律失常（服用β-受体阻滞剂或地高辛的患者可入组）；QT间期延长综合征或校正QT间期（QTc）>470ms（女性）的家族史；如果患者的 QTc 间期延长，但研究者评估的原因是起搏器（并且没有其他心脏异常）仍包含在该组中；CTCAE >= 2 级心脏瓣膜病；控制不佳的高血压（收缩压>150 mmHg或舒张压>100 mmHg； 10.患有活动性溃疡、活动性消化道瘘管或腹腔脓肿（除非已引流且无感染证据）、肠穿孔、无法解除的肠梗阻，以及入组前 28 天内有胃肠道穿孔史的患者； 11.活动性炎症性肠病、无法控制的恶心呕吐、无法吞咽研究药物，以及任何可能干扰药物吸收和代谢的胃肠道疾病； 12.活动性感染，如人类免疫缺陷病毒（HIV）、梅毒，以及未经治疗的活动性肝炎（HBV DNA 拷贝数 > 1000 IU/ml，且 HCV RNA 阳性）； 13.首次给药前 4 周内发生严重感染； 14.其他严重或无法控制的疾病，包括但不限于：未控制的大发作癫痫、不稳定的脊髓压迫、上腔静脉综合征或其他影响患者知情同意的精神障碍；免疫缺陷（除外脾切除），或研究者认为可能使患者暴露于高毒性风险的其他疾病；有精神活性物质滥用史且无法戒除或有精神障碍者；存在未愈合的伤口、活动性消化性溃疡、未愈合的骨折。计划在研究期间进行大手术。 15.首次给药前 30 天内接种过活疫苗或减毒活疫苗； 16.已知对研究药物的活性成分、非活性成分或具有相似化学结构的药物过敏，或已知对小分子酪氨酸激酶抑制剂 (TKi) 类抗血管生成药物过敏； 17. 既往接受过任何小分子酪氨酸激酶抑制剂 (TKi) 类抗血管生成药物。 18.妊娠或哺乳期女性，或预计在研究治疗期间怀孕者； 19.任何可能干扰研究结果、影响患者参与研究的既往或当前疾病、治疗或实验室异常，或研究者认为不适合参与研究的任何情况，包括理解力差和依从性低。

Exclusion criteria：

1. Patients with other malignant tumors (except those with carcinoma in situ that has been completely treated with no evidence of disease, thyroid cancer that has undergone curative treatment, and other malignancies for which curative treatment has been completed and the time from the last tumor-related treatment to screening exceeds 5 years); 2. Clear evidence of tumor recurrence or progression on imaging evaluation; 3. History of major organ transplantation; 4. History of severe psychiatric illness or brain dysfunction; history of substance abuse or drug addiction; 5. Any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonia, hepatitis, enteritis, nephritis, hypophysitis, vasculitis, uveitis), or patients requiring systemic corticosteroid therapy and/or immunosuppressive therapy (e.g., asthma requiring bronchodilators); the following are excluded: vitiligo, alopecia, Graves’ syndrome, psoriasis or eczema that has not required systemic treatment in the past 2 years, stable immune thyroiditis that is controlled after treatment, type I diabetes mellitus requiring only stable insulin therapy, and childhood asthma that has completely resolved; 6. Current use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (dose > 10 mg/day of prednisone or equivalent), with continued use within 2 weeks prior to enrollment. Topical use and systemic use of <= 10 mg/day of prednisone or equivalent are permitted; 7. Active bleeding (tumor-related bleeding to be assessed by the investigator), bleeding tendency, or patients at high risk of major bleeding (e.g., tumor involving major vessels or major bronchi, significantly uncontrolled bleeding after hemostatic treatment, uncured bronchiectasis), or tumor invading major blood vessels on imaging (e.g., carotid artery, pulmonary artery, peribronchial vessels), or patients requiring concomitant use of coumarin anticoagulants; history of fresh red hemoptysis >= 2.5 mL within 3 months prior to screening; 8. History of thrombosis or embolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack); 9. Severe cardiovascular disease or history including but not limited to: NYHA Class 3 and 4 congestive heart failure within 6 months prior to enrollment; unstable angina pectoris or newly diagnosed angina pectoris or myocardial infarction within 12 months prior to screening; arrhythmias requiring therapeutic intervention (patients receiving beta-blockers or digoxin may be enrolled); family history of long QT syndrome or corrected QT interval (QTc) > 470 ms (female); if the patient has a prolonged QTc interval but the cause is assessed by the investigator to be a pacemaker (and there are no other cardiac abnormalities), the patient may still be included; CTCAE >= Grade 2 valvular heart disease; uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg); 10. Patients with active ulcers, active gastrointestinal fistula or intra-abdominal abscess (unless drained with no evidence of infection), intestinal perforation, unresolved intestinal obstruction, or history of gastrointestinal perforation within 28 days prior to enrollment; 11. Active inflammatory bowel disease, uncontrolled nausea and vomiting, inability to swallow study medication, or any gastrointestinal disease that may interfere with drug absorption and metabolism; 12. Active infections such as human immunodeficiency virus (HIV), syphilis, or untreated active hepatitis (HBV DNA copy number > 1000 IU/ml, and HCV RNA positive); 13. Severe infection within 4 weeks prior to the first dose; 14. Other severe or uncontrolled diseases, including but not limited to: uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, or other mental disorders affecting the patient's informed consent; immunodeficiency (except splenectomy), or other conditions that the investigator believes may expose the patient to a high risk of toxicity; history of psychoactive substance abuse that cannot be abstained from or mental disorders; presence of unhealed wounds, active peptic ulcers, unhealed fractures. Planned major surgery during the study period; 15. Vaccination with live or live-attenuated vaccines within 30 days prior to the first dose; 16. Known allergy to the active or inactive ingredients of the study drug or to drugs with similar chemical structures, or known allergy to anti-angiogenic drugs of the small molecule tyrosine kinase inhibitor (TKi) class; 17. Prior treatment with any anti-angiogenic drug of the small molecule tyrosine kinase inhibitor (TKi) class; 18. Pregnant or breastfeeding women, or women who are expected to become pregnant during the study treatment period; 19. Any prior or current disease, treatment, or laboratory abnormality that may interfere with the study results or affect the patient's participation in the study, or any condition that the investigator considers unsuitable for participation in the study, including poor comprehension and low compliance.

研究实施时间：

Study execute time：

从 From 2026-03-31 00:00:00至 To 2029-03-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-30 00:00:00 至 To 2028-04-30 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	45
Group：	Experimental group	Sample size：	45
干预措施：	氟唑帕利：150mg，每日两次，口服，28天为一个治疗周期；法米替尼：15 mg，每日1次，口服，28天为一个治疗周期；治疗直至出现疾病进展、毒性不能耐受或方案规定的其他原因等。	干预措施代码：
Intervention：	Fuzuloparib: 150 mg, twice daily, orally, 28 days as a treatment cycle; Famitinib: 15 mg, once daily, orally, 28 days as a treatment cycle; Treatment continues until disease progression, unacceptable toxicity, or other reasons specified in the protocol.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	天津	市(区县)：
Country：	China	Province：	Tianjian	City：
单位(医院)：	天津市肿瘤医院	单位级别：	三甲
Institution hospital：	Tianjin Medical University Cancer Institute & Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	石家庄	市(区县)：
Country：	Ching	Province：	S	City：
单位(医院)：	河北医科大学第四医院（河北省肿瘤医院）	单位级别：	三甲
Institution hospital：	The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	CA-125应答率	指标类型：	主要指标
Outcome：	(CA-125 response)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存期	指标类型：	主要指标
Outcome：	Progression Free Survival,PFS	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	至后续首次治疗的时间	指标类型：	次要指标
Outcome：	Time to first subsequent anti-cancer treatment,TFST	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall survival,OS	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性终点(不良事件等)	指标类型：	次要指标
Outcome：	Safety endpoints (adverse events, etc.)	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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	70	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:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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：	病例记录表(Case Record Form, CRF)
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	(Case Record Form, CRF)
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：	2026-04-26 22:04:48