Consolidative Radiotherapy (CSRT) in Patients With Oligometastatic/Locally Advanced Unresectable Bilary Tract Cancer (BTC)

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

July 31, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2028

Conditions
Biliary Tract Cancer
Interventions
RADIATION

Consolidative radiotherapy

Consolidative radiotherapy: total dose and number of fractions will depend on the site of disease. Treatment will be given daily, or every other day, over 1 -3 weeks. Physicians should try to give the highest BED whenever possible while respecting normal tissue tolerance. All lesions are recommended to receive a biologically effective dose (BED) of 60 Gy or higher (BED10≥70), assuming α/β ratio of 10 and using the linear-quadratic model: BED = nd x \[1 + d/(α/β)\] where n is number of fractions and d is dose per fraction. Sometimes BED ≥80 Gy is preferred, with lower doses ≥50 Gy allowed at the discretion of the treating physician for concerns about normal tissue toxicity.

DRUG

Standard-of-care systemic therapy: Gemcitabine + cisplatin/oxaliplatin + Durvalumab/Pembrolizumab/Sintilimab/Toripalimab

Standard-of-care systemic therapy as decided by the treating medical oncologist: Gemcitabine + cisplatin/oxaliplatin + Durvalumab/Pembrolizumab/Sintilimab/Toripalimab

Trial Locations (1)

200032

Zhongshan Hospital, Shanghai

All Listed Sponsors
lead

Shanghai Zhongshan Hospital

OTHER

NCT06502080 - Consolidative Radiotherapy (CSRT) in Patients With Oligometastatic/Locally Advanced Unresectable Bilary Tract Cancer (BTC) | Biotech Hunter | Biotech Hunter