NCT06502080

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

Standard-of-care Systemic Therapy With or Without Consolidative Radiotherapy in Patients With Oligometastatic/Locally Advanced Unresectable Biliary Tract Cancer: an Open-label, Randomised, Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to investigate whether the inclusion of radiotherapy, in addition to standard-of-care systemic therapy, could improve the treatment effectiveness of patients with oligometastatic/locally advanced unresectable biliary tract cancer. The primary question that the trial aims to address is: does the addition of consolidative radiotherapy to standard-of-care systemic therapy for treating oligometastatic/locally advanced unresectable biliary tract cancer, result in a prolonged progression-free survival (PFS)? Researchers will assess whether radiotherapy can enhance PFS by comparing the survival time of patients with oligometastatic/locally advanced unresectable biliary tract cancer who receive standard-of-care systemic therapy alone versus those who receive standard-of-care systemic therapy along with consolidative radiotherapy. Participants in this trial will: Either receive or not receive consolidative radiotherapy following six cycles of standard-of-care systemic therapy.

Detailed description

Standard-of-care systemic therapy with or without consolidative radiotherapy in patients with oligometastatic/locally advanced unresectable biliary tract cancer: an open-label, randomised, controlled study. Eligible patients will be randomized in a 1:1 ratio to receive either current standard systemic therapy alone (control arm) or standard systemic therapy plus consolidative radiotherapy to all sites of known disease (experimental arm). Patients in both arms have the option of receiving upfront or subsequent standard palliative radiotherapy to any symptomatic sites requiring prompt intervention. Because of the different treatment modalities in the study, it is not possible to blind the patient or physician to the treatment arm. Follow-ups for tumor assessment will conclude 2 years after randomization.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2024-07-15
• Last updated: 2024-07-17

Locations

1 site across 1 country: China