NCT06946849

Second-line Regimen Combined With Radiotherapy Versus Without Radiotherapy in Patients With Locally Advanced/Oligometastatic ICC After Failure of First-line Treatment：an Open-label, Randomized, Controlled Phase II Clinical Study

Second-line Regimen Combined With Radiotherapy Versus Without Radiotherapy in Patients With Locally Advanced/Oligometastatic Intrahepatic Cholangiocarcinoma After Failure of First-line Treatment：an Open-label, Randomized, Controlled Phase II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Second-line regimen with or without consolidative radiotherapy in patients with oligometastatic/locally advanced unresectable intrahepatic cholangiocarcinoma: an open-label, randomised, controlled study.

Detailed description

Second-line regimen with or without consolidative radiotherapy in patients with oligometastatic/locally advanced unresectable intrahepatic cholangiocarcinoma: an open-label, randomised, controlled study. Eligible patients will be randomized in a 1:1 ratio to receive either second-line regimen alone (control arm) or second-line regimen plus consolidative radiotherapy to all sites of known disease (investigational 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-up for tumor assessment will conclude 52 weeks after randomization.

Conditions

• Intrahepatic Cholangiocarcinoma (Icc)

Interventions

Type	Name	Description
RADIATION	radiotherapy	Radiotherapy
DRUG	FOLFIRI or FOLFOX or Regorafenib	FOLFIRI or FOLFOX or Regorafenib

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: China