NCT07640048招募中不适用
A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors.
90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine/cisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur/gimeracil/oteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed ICC within 12 weeks after curative resection
- •Any T stage; N0/N+; M
- •At least one high-risk factor:
- •Preoperative tumor penetration of the liver capsule or extrahepatic direct invasion; Preoperative imaging showing multifocal lesions or a single lesion >5 cm; Vascular invasion (preoperative or postoperative pathology); Regional lymph node metastasis.
- •No prior systemic therapy for ICC.
- •ECOG performance status 0-
- •Expected survival ≥3 months.
- •Adequate organ function.
- •Agreement to use effective contraception (or surgical sterilization) during the study and for 120 days after the last dose.
- •Signed informed consent and anticipated good compliance with the study protocol.
排除标准
- •Immunosuppressive therapy within 28 days prior to enrollment (excluding topical/inhaled corticosteroids or physiologic steroid doses ≤10 mg/day prednisone equivalent).
- •Systemic anticancer herbs/immunomodulators (e.g., thymosin, interferons) within 4 weeks, except for pleural effusion control.
- •Uncontrolled cardiovascular disease:
- •Unstable angina/myocardial infarction Arrhythmias with QTc ≥450 ms (men) or ≥470 ms (women) NYHA Class III-IV heart failure or LVEF <50%
- •Active infections (IV antibiotics/antivirals required) or fever >38.5°C within 4 weeks; or major surgery within 3 weeks.
- •Active autoimmune/immunodeficiency diseases (e.g., hepatitis, pneumonitis, rheumatoid arthritis), except:
- •Hypothyroidism on stable hormone replacement Type 1 diabetes with controlled glucose Uncontrolled asthma requiring systemic bronchodilators (resolved childhood asthma allowed).
- •- Active infections: HIV/AIDS
- •HBV (DNA ≥500 IU/mL) or HCV (RNA-positive) unless:
- •HBV DNA <500 IU/mL + antiviral therapy ≥14 days
- •Prior/proposed organ transplantation (excluding corneal grafts).
- •Concurrent interventional trials or investigational drugs within 4 weeks without recovery to Grade ≤1 toxicity.
- •Hypersensitivity to study drug components.
- •Allogeneic transplant history/plans.
- •Uncontrolled psychiatric/substance abuse disorders.
- •Refractory hypertension (≥140/90 mmHg despite treatment).
- •Clinically significant bleeding/thromboembolism:
- •GI bleeding within 3 months Thrombotic events within 6 months (stroke, DVT/PE)
- •Coagulopathy (INR >1.5, PT >ULN+4s, aPTT >1.5×ULN) or anticoagulant use.
- •Proteinuria ≥++ on dipstick or 24-h urine protein ≥1 g.
- •Other high-risk conditions per investigator judgment.
研究者
Shunda Du
Chief Physician, Professor
Peking Union Medical College Hospital
研究点 (1)
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