Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer

Официальное название

A Single-Arm, Multicenter, Exploratory Clinical Study of Adebrelimab in Combination With Gemcitabine, Cisplatin, and Simvastatin for the Treatment of Patients With Locally Advanced or Metastatic Biliary Tract Malignancies

Обзор

This study will investigate the safety and effectiveness of a new combination treatment for patients with advanced bile duct cancer. The treatment combines standard chemotherapy drugs (gemcitabine and cisplatin) with two additional medications: adebrelimab and simvastatin. All participants in this study will receive the same four-drug combination. Researchers will closely monitor patients to see how well the tumors shrink, how long the treatment keeps the cancer from growing, and what side effects occur. The study is exploratory, meaning it aims to gather initial data on whether this four-drug combination is a promising approach for treating advanced biliary tract cancer.

Вмешательства

• Препарат Adebrelimab
  Adebrelimab is an anti-PD-L1 monoclonal antibody. During the initial combination phase (up to 8 cycles), it is administered intravenously at 1200 mg on Day 1 of each 21-day cycle. During the subsequent maintenance phase, it is administered at 1200 mg intravenously every 4 weeks.
• Препарат Gemcitabine + Cisplatin
  Standard gemcitabine and cisplatin chemotherapy regimen. This combination is administered intravenously only during the initial treatment phase for a maximum of 8 cycles (21-day cycles).
• Препарат Simvastatin 20mg
  Simvastatin is an HMG-CoA reductase inhibitor (statin). It is administered orally at a dose of 20 mg once daily continuously throughout both the initial combination phase and the subsequent maintenance phase until treatment completion criteria are met.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: From enrollment until the first documented disease progression or completion of study treatment, whichever occurs first, assessed up to approximately 2 years.]

Вторичные конечные точки (5)

• Progression-Free Survival (PFS) [Срок оценки: From enrollment until the first documented progression or death from any cause, assessed up to approximately 2 years]
• Overall Survival (OS) [Срок оценки: From enrollment until death from any cause, assessed up to approximately 3 years.]
• Disease Control Rate (DCR) [Срок оценки: From enrollment until the first documented disease progression or completion of study treatment, assessed up to approximately 2 years.]
• Duration of Response (DOR) [Срок оценки: From the first documented response until disease progression or death, assessed up to approximately 2 years.]
• Incidence of Treatment-Related Adverse Events (TRAEs) [Срок оценки: From the first dose of study treatment until 30 days after the last dose, assessed up to approximately 2 years.]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Histologically confirmed unresectable, locally advanced, or metastatic biliary tract adenocarcinoma (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer).
• No prior systemic therapy for advanced disease if initially diagnosed as unresectable or metastatic. Disease recurrence occurring more than 6 months after radical surgery or adjuvant therapy is allowed.
• ECOG Performance Status of 0 or 1.
• At least one radiologically measurable lesion as defined by RECIST 1.1 criteria (tumor lesion with longest diameter ≥10 mm on CT scan, or lymph node with short axis ≥15 mm).
• No severe dysfunction of major organs (heart, lungs, brain, etc.).

Критерии исключения

• Diagnosis of ampullary carcinoma.
• Presence of active or previously documented autoimmune or inflammatory disorders.
• Known hypersensitivity to any component of the study drugs (adebrelimab, gemcitabine, cisplatin, simvastatin).
• Severe liver dysfunction: laboratory tests within 14 days prior to enrollment showing total bilirubin > 1.5 times the upper limit of normal (ULN), AND/OR alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times ULN.
• Participation in another investigational drug or device clinical trial within 4 weeks prior to enrollment.
• Inability to comply with the study protocol for treatment or scheduled follow-up assessments.
• Any other condition deemed by the investigator as unsuitable for participation in the study.

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

• Tongji Hospital — Ухань

Идентификаторы

NCT: NCT07392541 · CHALLENGE-07

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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