Идёт набор NCT07640048

Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study

— Наблюдательное Intrahepatic Cholangiocarcinoma (Icc)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Adebrelimab, Gemcitabine, Cisplatin, S-1.
Кому может быть актуально: Состояния в реестре: Intrahepatic Cholangiocarcinoma (Icc). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors

Обзор

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.

Вмешательства

Препарат Adebrelimab
Adebrelimab administered intravenously at \[1200mg\] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.
Препарат Gemcitabine
Gemcitabine administered intravenously at \[1000 mg/m\^2\] on days 1 and 8 of each \[21\]-day cycle, for up to 8 cycles, in combination with cisplatin and adebrelimab，
Препарат Cisplatin
Cisplatin administered intravenously at \[25 mg/m\^2\] on days 1 and 8 of each \[21\]-day cycle, for up to 8 cycles, in combination with gemcitabine and adebrelimab.
Препарат S-1
S-1 (tegafur/gimeracil/oteracil) administered orally twice daily on days 1-14 of each 21-day cycle, dosed according to body surface area, for up to 8 cycles, in combination with adebrelimab.
Препарат Apatinib
Apatinib administered orally at \[250mg\] once daily continuously, for up to 17 cycles, in combination with adebrelimab.

Первичные конечные точки

Recurrence-Free Survival (RFS) [Срок оценки: Through study completion, an average of 4 years]

Вторичные конечные точки (1)

Overall Survival (OS) [Срок оценки: Through study completion, an average of 4 years]

Критерии участия

Критерии включения

Histologically confirmed ICC within 12 weeks after curative resection
Any T stage; N0/N+; M0.
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 0-2.
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.

Критерии исключения

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)