Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06903273

Aún no recluta

TisGCS for BTC: Neoadjuvant Tislelizumab, Gemcitabine, Cisplatin and S-1 for Resectable High-risk Cholangiocarcinoma

Intervencionista

Fase 2

National Cheng Kung University Hospital

Patrocinador: National Cheng-Kung University Hospital

Última actualización: 30 de marzo de 2025
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

To investigate the efficacy and tolerability of neoadjuvant tislelizumab, gemcitabine, cisplatin and S-1 (TisGCS) in patients with resectable high-risk iCCA.

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Categoría de tratamiento

Inhibidores de puestos de control

Erforderliche Mutationen

Ninguna

Ensayo iniciado

1 de julio de 2025

Última actualización por el patrocinador

30 de marzo de 2025

Finalización estimada

1 de julio de 2028

Contacto del estudio

Nombre:Clinical Trial Center, National Cheng Kung University Hospital

Correo electrónico:ctcnckuh@mail.hosp.ncku.edu.tw

Teléfono:886-6-2353535

Elegibilidad

Criterios de inclusión

- Subjects must meet the criteria of either (A) or (B), plus 1. to 6. (A) High-risk group (HR) Subjects have histologically-confirmed and potentially resectable intrahepatic cholangiocarcinoma, according to the definition of American Joint Cancer Committee staging system, 8th edition (AJCC 8th).

Plus at least one of the following high-risk features,

1. Solitary tumor with a maximal diameter ≥5 cm in the absence of vascular invasion.

2. ≥T1b disease which is resectable.

3. Multifocal tumors or single tumor with satellite nodules at the same anatomic liver lobe which is/are resectable.

4. Tumor(s) with macroscopic intrahepatic vascular invasion but is/are potentially resectable.

5. Image or histological evidence of hilar or portal lymph node involvement (N1).

6. Initial serum cancer antigen-199 (CA199) ≥200 U/mL.

(B) Very early recurrence group (VER) Subjects with previously resected cholangiocarcinoma under a curative intent and have an early recurrent disease (≤6 months post curative surgery) confined to the liver, with/without antecedent adjuvant local or systemic therapies, and can be re-resected under a curative intent.

1. Subjects present with at least one measurable lesion which can be accurately assessed by conventional techniques at least 1.0 cm by computed tomography (CT) or magnetic resonance imaging (MRI).

2. Subjects are above 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤1, have a life expectancy >3 months, have surgically resectable disease and are physically competent and willing to receive a curative operation following the study protocol

3. Subjects have adequate organ functions, including bone marrow reserve with a leukocyte count ≥3,000 /µL and platelet count ≥50,000 /µL, hepatic reserve with a serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin ≤3 times of upper normal testing limits (biliary drainage is permitted), renal reserve with a creatinine clearance ≥60 mL/min and cardiac reserve with a New York Heart Association (NYHA) functional classification I at baseline.

4. Subjects have or agree to establish a vascular access that permits intravenous administration of medications and are capable of ingesting capsules per oral.

5. Subjects with reproductive potentials are willing to accept contraceptive measures during the trial.

6. Subjects are functionally and cognitively capable to be informed of the trial contents and objectives (including obtaining blood and tumor tissue for the trial investigation), and agree to sign the written consent for enrollment.

Criterios de exclusión

1. Subjects have metastatic (M1) disease, recurrent cholangiocarcinoma which cannot be resected, recurrent cholangiocarcinoma which can be re-resected but occurs >6 months post previous surgery, or any other primary malignancies in which the subjects have been in disease-free status less than 2 years, excluding carcinoma in situ or resectable skin cancer.

2. Subjects have received a systemic therapy with either chemotherapeutics or immune checkpoint inhibitors, a major abdominal surgery or radiotherapy within 4 weeks before the trial enrollment.

3. Subjects are known to be severely allergic to any of the studied therapeutics.

4. Subjects have underlying chronic illnesses, including cardiopulmonary diseases, ischemic heart disease, inflammatory bowel disease, poorly-controlled diabetes mellitus, liver cirrhosis and/or debilitating autoimmune diseases or conditions.

5 Subjects are receiving or have received a systemic administration of an equivalent dose of daily 10 mg prednisone or above for ≥14 days in whatever indications within 4 weeks before the trial enrollment, or immunosuppressives for ≥7 days within 4 weeks before the trial enrollment.

6. Subjects have active bacterial, viral, fungal or mycobacterial infections that require systemic therapy, including active infection with human immunodeficiency virus (HIV), hepatitis B or C virus (HBV or HCV).

7. Subjects are planning to conceive or already in pregnancy or breastfeeding. 8. Subjects are currently participating in any other clinical trials or studies which potentially interfere the protocol commencement.

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir35

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: neoadjuvant tislelizumab/gemcitabine/cisplatin/S-1

Intervenciones:

Tislelizumab

Medidas de resultado

Medidas de resultado primarias

R0 resection rateFrom enrollment to surgical resection at 2 weeks

Margin-free resection (R0) rate: (Number of patients with surgical results achieving an uninvolved margin under microscopic and macroscopic inspection) / (Number of patients receiving a surgery) x 100%

Medidas de resultado secundarias

Objective response rateFrom enrollment to the end of neoadjuvant therapy at 2 weeks

Patients who achieve a complete or partial response as defined by revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Overall survivalFrom the date of enrollment until the date of death from any cause

The time interval from enrollment to death by any causes

Event-free survivalFrom the date of enrollment until the date of any predefined event which happens first

The time interval from enrollment to an event, defined as disease progression, recurrence, withdrawal from trial treatment, initiation of subsequent anticancer treatment or death by any cause, in whichever happens first.

Disease control rateFrom enrollment to the end of neoadjuvant therapy at 2 weeks

Patients who achieve a complete response, partial response or stable disease, as defined by revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Protocol completion rateFrom enrollment to the end of neoadjuvant therapy at 2 weeks

Patients who complete the protocol neoadjuvant treatment / Enrolled patients X100%

Adverse events related to protocol treatmentFrom enrollment to the end of neoadjuvant therapy at 2 weeks

Patients who present with ≥grade III adverse events resulting from protocol treatment per National Cancer Institute- Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE 5.0).

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Sitios del ensayo

National Cheng Kung University Hospital

Tainan, TW

Nombre:Chih Chieh Yen, MD., PhD.

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