Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Durvalumab and Lenvatinib in Patients With Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma: a Phase 2 Study(HAIC-quad Trial)

Обзор

At present, the first-line treatment for patients with advanced unresectable intrahepatic cholangiocarcinoma is mainly systemic treatment, but the improvement in efficacy is limited and is not enough to meet the current clinical treatment needs. Hepatic artery infusion chemotherapy (HAIC) has the advantages of increasing local drug concentration and reducing toxic side effects compared to systemic intravenous chemotherapy. In order to enable patients with advanced intrahepatic cholangiocarcinoma to obtain better treatment effects, this study plans to explore HAIC combined with durvalumab and lenvatinib as the first-line treatment for patients with locally advanced or metastatic ICC, in order to provide a better treatment choice for their comprehensive treatment.

Вмешательства

• Препарат Durvalumab
  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
• Препарат hepatic arterial infusion chemotherapy (HAIC)
  hepatic arterial infusion chemotherapy (HAIC) : GemCis regimen was adopted, with the specific regimen as follows: cisplatin 60 mg/m2 on the first day, arterial infusion for half an hour, gemcitabine 1000 mg/m2 on the first day, arterial infusion for half an 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).
• Препарат Lenvatinib
  Lenvatinib 8mg (weight \<60 kg) or 12mg (weight ≥60 kg) oral QD, during combination therapy, starting on day 3 of each 3-week cycle (determined by the investigator)

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 26 months]

Вторичные конечные точки (3)

• Overall Survival (OS) [Срок оценки: Up to approximately 36 months]
• Progression-free Survival (PFS) [Срок оценки: Up to approximately 26 months]
• Number of Participants Who Experience One or More Adverse Events (AE) [Срок оценки: Up to approximately 36 months]

Критерии участия

Критерии включения

• Histologically confirmed intrahepatic cholangiocarcinoma, with a preliminary diagnosis of unresectable or metastatic disease and no previous systemic treatment.

Anatomical factors: ① Patients with invasion of the portal vein, hepatic vein or main bile duct, who cannot undergo resection and reconstruction; ② Patients with decompensated cirrhosis or severe portal hypertension, and the residual liver FLR does not meet the safe liver resection decision-making system Biological factors: ① Multiple tumors in the left and right livers; ② Metastasis to distant lymph nodes such as the para-aorta or distant organ metastasis

• Disease recurrence > 6 months after radical surgery; if adjuvant therapy is given after surgery, patients > 6 months after completion of adjuvant therapy (chemotherapy and/or radiotherapy) are eligible for inclusion.
• WHO/ECOG PS of 0 or 1
• There was at least 1 target lesion (TL) that met the RECIST 1.1 criteria

Критерии исключения

• Patients who have received systemic treatment in the past.
• Patients with severe liver dysfunction (Child-Pugh C grade), or significant jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome.
• Patients with severe and uncorrectable coagulation dysfunction.
• Patients with active hepatitis or severe infection who cannot be treated simultaneously.
• Patients with cachexia or multiple organ failure.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• West China Hospital, Sichuan University — Чэнду

Идентификаторы

NCT: NCT06859684 · HAIC-quad-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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