NCT07291947招募中1 期
Phase I/II Clinical Study of Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy (PULSAR) Combined With Immunotherapy and Chemotherapy in Patients With Cholangiocarcinoma
Wang Xin1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety of immunotherapy and chemotherapy combined with PULSAR radiation therapy
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of PULSAR in combination with dual immune checkpoint inhibitors (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) and GC chemotherapy in patients with locally advanced or metastatic cholangiocarcinoma. The secondary objective of this study is to investigate the immunological impact of PULSAR combined with dual immune therapy (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) on the tumor microenvironment and systemic immune responses in cholangiocarcinoma patients.
详细描述
After confirmation of eligibility, enrolled patients will undergo radiation CT simulation and planning per standard of care. IV contrast will be administered with CT simulation at the treating physician's discretion though is not required.
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
- •Signed informed consent. The subject has fully understood and accepted the purpose, content, expected efficacy, mechanism of action, and risks of the study, and has signed the informed consent form.
- •Age 18-75 years, regardless of gender.
- •Histopathologically or cytologically confirmed locally advanced or metastatic cholangiocarcinoma.
- •At least one measurable lesion based on RECIST 1.1 criteria.
- •ECOG performance status score of 0-
- •Expected survival time ≥3 months.
- •Willing to comply with study procedures and able to undergo treatment (including radiotherapy, immunotherapy, chemotherapy) and follow-up.
- •No contraindications to the use of PD-1, PD-L1 inhibitors, gemcitabine, or cisplatin.
- •No contraindications to radiotherapy.
- •Organ function levels meet the following requirements: - Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; - Platelet (PLT) count ≥ 80 × 10⁹/L; - Hemoglobin (Hb) level ≥ 90 g/L; - Total bilirubin (TBil) level ≤ 1.5 times the upper limit of normal (ULN); - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN; if liver metastases are present, ≤ 5 times ULN; - Serum creatinine ≤ 1.5 times ULN, or calculated creatinine clearance rate ≥ 50 ml/min; - International normalized ratio (INR) ≤ 1.5 times ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, unless the subject is receiving anticoagulant therapy. - Hepatitis B surface antigen (HBsAg) positive with peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≤ 1 × 10³ copies/L; if HBsAg positive and peripheral blood HBV-DNA titer ≥ 1 × 10³ copies/L, subjects may be included if the investigator determines that the chronic hepatitis B is stable and poses no additional risk.
- •Women of childbearing potential must agree to use appropriate contraceptive measures during the study period. Additionally, a serum or urine pregnancy test performed within 24 hours prior to the initiation of chemotherapy must be negative.
- •Women must be non-lactating.
排除标准
- •Previously treated with anti-PD-1 or anti-PD-L1 antibodies.
- •Received any investigational drug treatment within 4 weeks prior to the first administration of the study drug.
- •Simultaneous participation in other clinical studies, unless it is an observational (non-interventional) clinical study or the follow-up phase of an interventional clinical study.
- •Previously received radiotherapy to the upper abdomen.
- •Uncontrolled severe diseases that the investigator considers may affect the subject's ability to receive study protocol treatment, such as severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infections, active peptic ulcers, etc.
- •Active known or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator treatment). Patients with hypothyroidism requiring hormone replacement therapy and those with skin conditions not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia) may be included.
- •Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within the past year will be excluded, even if treated. Patients with a history of active pulmonary tuberculosis infection more than one year ago will also be excluded unless evidence is provided that they have undergone standard anti-tuberculosis treatment.
- •Patients requiring long-term systemic corticosteroid therapy (equivalent to >10 mg prednisone/day) or any other form of immunosuppressive therapy. Patients using inhaled or topical corticosteroids may be included.
- •Uncontrolled cardiac disease, such as: New York Heart Association (NYHA) Class II or higher heart failure; unstable angina; myocardial infarction within the past year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. Additionally, dementia, altered mental status, or any psychiatric disorders that could impair the ability to understand, provide informed consent, or complete questionnaires.
- •History of allergy or hypersensitivity to any component of the treatment.
- •History of malignant tumors within the past 5 years, except for completely treated basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after radical surgery.
- •Previously received systemic therapy for cholangiocarcinoma.
- •Positive for hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies.
- •Active infection requiring systemic treatment.
- •Other conditions deemed unsuitable for inclusion by the investigator.
研究组 & 干预措施
PULSAR Combined with Immunotherapy and Chemotherapy
Experimental
PULSAR Combined with Immunotherapy and Chemotherapy
干预措施: Iparomlimab and Tuvonralimab Injection (QL1706) (Drug)
PULSAR Combined with Immunotherapy and Chemotherapy
Experimental
PULSAR Combined with Immunotherapy and Chemotherapy
干预措施: PULSAR (Radiation)
结局指标
主要结局
Safety of immunotherapy and chemotherapy combined with PULSAR radiation therapy
时间窗: Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment
Evaluation of reported adverse events (AEs) and serious adverse events (SAEs), according to CTCAE v5.0. Evaluation of changes from Baseline during the Treatment and Follow-up periods
次要结局
- immunological impact of immunotherapy and chemotherapy combined with PULSAR radiation therapy(Baseline, every three weeks in the treatment period, 30 days and 3 months after treatment)
研究者
Wang Xin
Clinical Professor
West China Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Pulsed Radiofrequency Versus Hyaluronidase Hydrodissection for Treatment of Carpal Tunnel SyndromeNCT07269613Sohag University56
招募中
不适用
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode SystemThyroid NoduleNCT07287176Pulse Biosciences, Inc.100
招募中
不适用
Efficacy Analysis of Personalized-Target Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Tinnitus: A Single-Center, Single-Blind Randomized Clinical TrialChronic TinnitusNCT07267455Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University116
招募中
不适用
A Study of Multiparametric Ultrasound Imaging MethodsThyroid NodulePancreatic CancerNCT07270237Memorial Sloan Kettering Cancer Center85
尚未招募
不适用
Efficacy and Safety of Irregular Pulsed Radiofrequency (Sluijter-Teixera Poisson) Versus Regular Pulsed Radiofrequency to the Gasserian Ganglion for Treatment of Primary Trigeminal NeuralgiaTrigeminal NeuralgiaNCT07275229Sohag University62