medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/ms2025-194medsovet-9245Research ArticleИММУНОТЕРАПИЯIMMUNOTHERAPYРоль иммунотерапии в лечении опухолей билиарного тракта: обзор современных данных и собственный опытRole of the immunotherapy in the treatment of biliary tract cancers: Review of current clinical trials and retrospective analysishttps://orcid.org/0000-0002-1834-0981ЛединЕ. В.LedinE. V.

Ледин Евгений Витальевич, к.м.н., руководитель центра химиотерапии, заведующий отделением химиотерапии,

 125284, Москва, 2-й Боткинский проезд, д. 5, корп. 4

Evgeniy V. Ledin, Cand. Sci. (Med.), Head of the Chemotherapy Center, Head of the Chemotherapy Department, Medical Oncologist

5, Bldg. 4, 2nd Botkin Proezd, Moscow, 125284

ledin@inbox.ruhttps://orcid.org/0000-0003-1032-3818СтоляровВ. И.StolyarovV. I.

Столяров Владимир Игоревич, врач-химиотерапевт, онколог

125284, Москва, 2-й Боткинский проезд, д. 5, корп. 4; 

Vladimir  I. Stolyarov,  Medical  Oncologist,

5, Bldg. 4, 2nd   Botkin  Proezd, Moscow, 125284

vladimirvladimir_stolyarov1@mail.ruhttps://orcid.org/0000-0003-3200-6426ЧуйковаЕ. О.ChuykovaE. O.

Чуйкова Елизавета Олеговна, студент

119048,Москва, ул. Трубецкая, д. 8, стр. 2

Elizaveta О. Chuykova, Student

8, Bldg. 2, Trubetskaya St., Moscow, 119991

e.chujkova@inbox.ruКлиническая больница МЕДСИРоссияMEDSI Clinical Hospital №2Russian FederationПервый Московский государственный медицинский университет имени И.М. Сеченова (Сеченовский Университет)РоссияSechenov First Moscow State Medical University (Sechenov University)Russian Federation2025300720250102030Copyright © Ледин Е.В., Столяров В.И., Чуйкова Е.О., 20252025Ледин Е.В., Столяров В.И., Чуйкова Е.О.Ledin E.V., Stolyarov V.I., Chuykova E.O.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/9245Введение

Введение. Опухоли билиарного тракта (ОБТ) представляют собой агрессивные злокачественные новообразования с ограниченными терапевтическими возможностями и низкой общей выживаемостью. В последние годы внедрение иммунотерапии изменило парадигму лечения ОБТ, особенно в сочетании с химиотерапией. В настоящей работе приводится подробный анализ современных данных, а также оценивается эффективность химиоиммунотерапии у пациентов с нерезектабельной и/или метастатической холангиокарциномой в условиях реальной клинической практики.

Цель

Цель. Оценить клинические исходы применения комбинированной химиоиммунотерапии (GemCis + дурвалумаб/пембролизумаб) у пациентов с ОБТ в российской практике, включая показатели общей выживаемости (ОВ), выживаемости без прогрессирования (ВБП), частоты объективного ответа (ЧОО) и токсичности.

Материалы и методы

Материалы и методы. В ретроспективный анализ включены 23 пациента с подтвержденной холангиокарциномой, получившие лечение в трех центрах АО «ГК «МЕДСИ» с 2020 по 2024 г. Основной режим терапии включал гемцитабин, цисплатин и ингибитор PD-1/PD-L1 с последующей поддерживающей иммунотерапией. Оценка эффективности проводилась по критериям RECIST v1.1, статистический анализ выполнялся методом Каплана – Мейера.

Результаты

Результаты. Медиана ВБП составила 8,0 мес. (95% ДИ: 6,6–9,3), медиана ОВ – 14,0 мес. (95% ДИ: 8,4–19,5). ЧОО составила 25% (5 частичных ответов, полные ответы отсутствовали), частота контроля заболевания – 68,5%. Осложнения 3–4-й степени зарегистрированы у 39% пациентов, включая гематологическую токсичность и редкие иммуноопосредованные реакции.

Выводы

Выводы. Результаты настоящего анализа подтверждают эффективность химиоиммунотерапии в реальной клинической практике и коррелируют с данными крупных международных исследований. Включение ингибиторов PD-1/PD-L1 в схему первой линии терапии ОБТ демонстрирует клинически значимое улучшение показателей выживаемости и контроля заболевания, особенно у пациентов с благоприятным ответом на терапию.

Introduction

Introduction. Biliary tract cancers (BTC) are aggressive malignancies with limited therapeutic options and poor overall survival. In recent years, the introduction of immunotherapy has shifted the treatment paradigm for BTC, particularly in combination with chemotherapy. This study presents a detailed analysis of current clinical data and evaluates the efficacy of chemoimmunotherapy in patients with unresectable and/or metastatic cholangiocarcinoma in routine clinical practice.

Aim

Aim. To assess the clinical outcomes of combined chemoimmunotherapy (GemCis + durvalumab/pembrolizumab) in patients with BTC in Russian clinical settings, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and toxicity profiles.

Materials and methods

Materials and methods. This retrospective analysis included 23 patients with histologically confirmed cholangiocarcinoma treated between 2020 and 2024 at three centers of JSC “MEDSI Group”. The standard treatment regimen consisted of gemcitabine, cisplatin, and a PD-1/PD-L1 inhibitor followed by maintenance immunotherapy. Treatment efficacy was evaluated according to RECIST v1.1 criteria, and survival analysis was performed using the Kaplan–Meier method.

Results

Results. The median PFS was 8.0 months (95% CI: 6.6–9.3), and the median OS was 14.0 months (95% CI: 8.4–19.5). The ORR was 25%, with five partial responses and no complete responses; the disease control rate was 68.5%. Grade 3–4 adverse events occurred in 39% of patients, including hematologic toxicity and rare immune-related adverse events.

Conclusion

Conclusion. The findings of this analysis support the real-world efficacy of chemoimmunotherapy and are consistent with data from large international trials. Incorporation of PD-1/PD-L1 inhibitors into first-line treatment regimens for BTC provides a clinically meaningful improvement in survival outcomes and disease control, particularly among patients demonstrating favorable responses to therapy.

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The authors declare that there are no conflicts of interest present.