HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma

Conditions

• Advanced Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  Given by IV
• Gemcitabine — DRUG
  Given by IV
• Cisplatin — DRUG
  Given by IV

Study Details

This study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.

Key Dates

Start date

Jun 10, 2025

Status verified

Mar 2026

Primary completion

Nov 19, 2028

Completion

Nov 19, 2030

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm - Liver-RT + Durvalumab
  Participants will receive treatment in sequence with standard of care systemic therapy
• Experimental: Standard of Care Arm - Durvalumab + Gemcitabine + Cisplatin
  Participants will receive treatment in sequence with standard of care systemic therapy

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

• Eugene Koay, MD,PHD
  (713) 563-2381
  [email protected]

Locations (1)

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