NCT07635290进行中（未招募）2 期
A Phase II Clinical Trial of Anlotinib Combined With Cadonilimab and PULSAR in Previously Treated Advanced Unresectable or Metastatic Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the safety and preliminary efficacy of anlotinib combined with cadonilimab and PULSAR in previously treated advanced unresectable or netastatic biliary tract cancer.
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
- •Age: 18-75 years, regardless of gender.
- •Histopathologically confirmed diagnosis of biliary tract cancer (BTC).
- •Patients with unresectable or metastatic BTC who have progressed after at least one line of standard systemic therapy
- •At least one measurable lesion (RECIST v1.1) not previously irradiated.
- •ECOG Performance Status (PS): 0-
- •Expected survival ≥ 3 months.
- •Willing and able to comply with study procedures, treatment, and follow-up.
- •No contraindications to radiotherapy.
- •Adequate organ function: WBC ≥ 2.5×10⁹/L, ANC ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; Hemoglobin (HGB) ≥ 90 g/L (no transfusion or EPO dependence within 7 days); Total bilirubin (Tbil) ≤ 1.5×ULN; ALT/AST ≤ 5×ULN;Albumin ≥ 30 g/L; INR ≤ 1.5×ULN; Serum creatinine (Cr) ≤ 1.5×ULN;Urine protein ≤ 1+
- •Prior immunotherapy must have been discontinued for at least 4 weeks (to avoid cross-reactivity).
- •Voluntary participation with signed informed consent form.
排除标准
- •History of severe allergic reactions to chimeric, human, or humanized antibodies, or fusion proteins.
- •Pregnant or lactating women; men or women of childbearing potential who are unwilling or unable to use effective contraception.
- •History of other malignancies within the past 5 years, except for: malignancies treated with curative intent with no known active disease for ≥ 5 years prior to first dose and with low potential risk of recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease.
- •Clinically symptomatic moderate to large volume pleural or peritoneal effusion.
- •Active bleeding or coagulopathy (PT > 16 s, APTT > 43 s, INR > 1.5 × ULN), bleeding tendency, or ongoing thrombolytic, anticoagulant, or antiplatelet therapy.
- •History of gastrointestinal bleeding within the past 6 months, or clear evidence of gastrointestinal bleeding tendency, such as: known active localized ulcerative lesions, fecal occult blood ≥ 2+ (patients with persistent fecal occult blood 1+ should undergo gastroscopy).
- •Severe gastric or esophageal varices requiring interventional treatment.
- •Untreated active hepatitis B. (Note: Subjects with hepatitis B who are receiving antiviral therapy and have HBV viral load < 2000 IU/mL may be permitted to participate in the study.)
- •Active hepatitis C, defined as positive anti-HCV antibody or positive HCV-RNA with abnormal liver function.
- •History of psychoactive substance abuse that cannot be discontinued, or history of psychiatric disorders.
- •History of solid organ or bone marrow transplantation, or active autoimmune disease requiring systemic treatment within 2 years prior to first dose.
- •Known immunodeficiency disease or HIV infection.
- •Objective evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function.
- •Major surgery (e.g., hepatic or other site) within 4 weeks prior to first dose, or minor surgery (e.g., simple excision, tooth extraction) within 1 week prior to first dose.
- •Receipt of vaccination within 30 days prior to first dose.
- •Occurrence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to first dose.
- •Any clinically significant laboratory or physical abnormality that, in the investigator's opinion, may affect safety evaluation, such as: active infection requiring systemic treatment, uncontrolled diabetes, hypertension that cannot be controlled to within normal range (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg) after treatment with ≤ 2 antihypertensive drugs, myocardial infarction within the past 6 months, thyroid dysfunction ( > NCI CTCAE v5.0 Grade 1), etc.
- •Any other condition that the investigator considers inappropriate for enrollment.
研究者
研究点 (1)
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