Phase II Clinical Study of GemOX Hepatic Arterial Infusion Combined with Lenvatinib and Toripalimab for Advanced and Unresectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

Обзор

For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects. This study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.

Вмешательства

• Препарат chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.
  Toripalimab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight\<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd) Chemotherapy by hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (3)

• Surgical resection rate [Срок оценки: through study completion, an average of 1 year]
• Pathological complete response rate (pCR rate) [Срок оценки: through study completion, an average of 1 year]
• Overall survival (OS) [Срок оценки: through study completion, an average of 5 years]

Критерии участия

Критерии включения

• Age 18 or above
• Histopathological or cytological diagnosis of intrahepatic cholangiocarcinoma or gallbladder cancer
• A tumor that cannot be removed by three independent surgeons.
• Expected lifespan ≥ 12 weeks
• ECOG PS score 0-1 points
• The patient voluntarily participates and signs an informed consent form;
• Expected compliance is good, able to follow up on efficacy and adverse reactions according to the protocol requirements.

Критерии исключения

• Use any systemic research anti-cancer drugs
• Active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which may include hormone replacement therapy)
• Asthma requires the use of bronchodilators for medical intervention
• Congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection
• Clinical symptoms or uncontrolled heart disease
• Severe infection within 4 weeks before the first use of medication
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
• Vaccination with attenuated live vaccine within 4 weeks before treatment
• Other systemic malignant tumors in the past 5 years

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

• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Публикации

• Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085. PMID 40812353

Идентификаторы

NCT: NCT06852287 · E20241047 · GOLD-HAIC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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