Идёт набор NCT07030140

Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma

Фаза II С лечением Cholangiocarcinoma Hilar Cholangiocarcinoma Bile Duct Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Stereotactic Body Radiotherapy (SBRT), Tislelizumab, Gemcitabine, Cisplatin or Oxaliplatin.
Кому может быть актуально: Состояния в реестре: Cholangiocarcinoma, Hilar Cholangiocarcinoma, Bile Duct Cancer. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase II, Single-arm, Prospective Clinical Study of Neoadjuvant Therapy With Tislelizumab Combined With Radiotherapy and Gemcitabine-Platinum Chemotherapy for Borderline Resectable or Unresectable Hilar Cholangiocarcinoma

Обзор

This is a phase II, single-arm, prospective clinical trial designed to evaluate the efficacy and safety of neoadjuvant therapy combining stereotactic body radiotherapy (SBRT), GP chemotherapy (gemcitabine and cisplatin/oxaliplatin), and tislelizumab in patients with borderline resectable or unresectable hilar cholangiocarcinoma. Eligible patients will receive SBRT followed by three cycles of tislelizumab plus GP chemotherapy. Patients with resectable disease after evaluation may undergo surgery and receive postoperative treatment as recommended by the multidisciplinary team. Those who remain unresectable will receive three additional cycles of systemic therapy. The primary endpoint is overall survival (OS); secondary endpoints include R0 resection rate, pathological complete response (pCR), surgical difficulty, progression-free survival (PFS), local control rate, and treatment-related safety.

Подробное описание

Hilar cholangiocarcinoma is a rare but highly aggressive malignancy, often diagnosed at advanced stages due to its asymptomatic progression and challenging anatomical location. R0 resection remains the cornerstone of curative therapy, but many patients are initially considered borderline resectable or unresectable due to vascular involvement or lymph node metastasis.

Recent studies suggest that neoadjuvant therapy may improve resectability and survival outcomes by reducing tumor burden and modulating the tumor microenvironment. Stereotactic body radiotherapy (SBRT) offers precise local control, while GP chemotherapy (gemcitabine and cisplatin/oxaliplatin) has demonstrated efficacy in biliary tract cancers. Immunotherapy with PD-1 inhibitors, such as tislelizumab, has shown promise in enhancing antitumor immunity, especially when combined with radiotherapy and chemotherapy.

This phase II, single-arm, prospective study aims to evaluate the efficacy and safety of neoadjuvant SBRT followed by tislelizumab and GP chemotherapy in patients with borderline resectable or unresectable hilar cholangiocarcinoma. Patients will first receive SBRT to the gross tumor volume (GTV) at a dose of either 5Gy × 5-8 fractions or 4Gy × 15 fractions. After radiotherapy, participants will receive three cycles of tislelizumab (200mg Q3W) in combination with gemcitabine (1000mg/m² on Days 1 and 8) and cisplatin (25mg/m² on Days 1 and 8) or oxaliplatin (100mg/m² on Day 1), repeated every 21 days.

Patients will be re-evaluated after three cycles. If resectable, patients may undergo surgery, followed by additional postoperative therapy based on MDT recommendations. If unresectable, an additional three cycles of systemic therapy will be administered. The primary endpoint is overall survival (OS). Secondary endpoints include R0 resection rate, pathological complete response (pCR), surgical difficulty, local control rate, progression-free survival (PFS), and treatment-related adverse events.

Вмешательства

Лучевая терапия Stereotactic Body Radiotherapy (SBRT)
SBRT to the primary tumor and metastatic lymph node at a dose of either 5 Gy × 5-8 fractions or 4 Gy × 15 fractions, delivered prior to systemic therapy.
Препарат Tislelizumab
Tislelizumab 200 mg administered intravenously every 3 weeks (on Day 1 of each 21-day cycle), for three to six cycles depending on surgical eligibility.
Препарат Gemcitabine
Gemcitabine 1000 mg/m² administered intravenously on Days 1 and 8 of each 21-day cycle, for three to six cycles.
Препарат Cisplatin or Oxaliplatin
Cisplatin 25 mg/m² on Days 1 and 8 or oxaliplatin 100 mg/m² on Day 1 of each 21-day cycle, selected based on patient condition, for three to six cycles.

Первичные конечные точки

Overall Survival (OS) [Срок оценки: Up to 36 months]

Вторичные конечные точки (5)

R0 Resection Rate [Срок оценки: At the time of surgery (approx. 3-6 months from enrollment)]
Pathological Complete Response (pCR) [Срок оценки: At the time of surgery]
Progression-Free Survival (PFS) [Срок оценки: Up to 24 months]
Local Control Rate [Срок оценки: 6, 12, 18, and 24 months]
Treatment-related Adverse Events [Срок оценки: From treatment initiation up to 90 days after last dose]

Критерии участия

Критерии включения

Age 18-75 years, histologically or cytologically confirmed hilar cholangiocarcinoma
Borderline resectable or unresectable disease based on imaging and MDT evaluation
ECOG performance status 0-1
Adequate hematologic, hepatic, and renal function
No prior anti-tumor therapy for current diagnosis
Expected survival ≥ 3 months
Signed informed consent