HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC

Официальное название

HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC: A Single-Arm, Multicenter Phase II Clinical Trial

Обзор

Intrahepatic cholangiocarcinoma (ICC) has a poor prognosis. The aim of this study is to investigate the efficacy and safety of GP-HAIC combined with immunosuppressants in the treatment of initially unresectable ICC patients, as well as its role in conversion therapy. A prospective study was conducted on the data of locally advanced unresectable ICC patients receiving GC-HAIC combined with immunosuppressive therapy, evaluating the treatment efficacy and safety.

Подробное описание

Hepatic arterial infusion chemotherapy (HAIC)-GC（Gemcitabine+Cisplatin） combined with Durvalumab OR Pembrolizumab

Вмешательства

• Препарат PD-L1 inhibitor
  PD-L1 inhibitor Drug: Durvalumab OR pembrolizumab Durvalumab: During combination therapy: 1500 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 1500 mg Q4W Pembrolizumab: During combination therapy: 200 mg, Q3W, during combination therapy, on days 3-5 of each 3-week cycle (determined by the investigator); during maintenance therapy: 200 mg Q4W
• Процедура HAIC
  Hepatic arterial infusion chemotherapy (HAIC) combined with PD-L1 inhibitor 1.Therapy:hepatic arterial infusion chemotherapy (HAIC) hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was adopted, with the specific regimen as follows: Cisplatin 20mg/m2, maintained for 3 hours. Gemcitabine 0.6g/m2, maintained for 1 hour , repeated once every 3 weeks, and 4-6 cycles of treatment (the specific number of cycles was determined by the investigator according to the patient's condition).

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: 2 year]

Вторичные конечные точки (2)

• Overall Survival (OS) [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
• Progression-free Survival (PFS) [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]

Критерии участия

Критерии включения

• Age: Age ≥ 18 years old.
• Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging.
• Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria).
• Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1.
• Expected lifespan: Expected lifespan ≥ 3 months.
• Liver function: Child Pugh classification A or B.
• Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol.
• Not receiving relevant treatment: Not receiving systematic treatment for ICC.

Критерии исключения

• Previous treatment: Previously received systemic treatment for ICC.
• Poor physical condition: ECOG physical condition score ≥ 2.
• Poor liver function: Child Pugh grading>8.
• Short life expectancy: Life expectancy is less than 3 months.
• Merge with other malignant tumors: have other malignant tumors or a history of other malignant tumors.
• Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys.
• Drug allergy or intolerance: Allergic to the investigational drug or its excipients.
• Other: Other situations that the researcher deems unsuitable to participate in this study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Eastern Hepatobiliary Surgery Hospital — Шанхай

Идентификаторы

NCT: NCT07364305 · Lalo · 20241130

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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