HYPERION CCA: a Phase 2 Trial of Systemic Therapy With or Without Liver-directed Radiation Therapy for Patients With Advanced Intrahepatic Cholangiocarcinoma
Treatments studied
Part of Cancer clinical trials.
Phase 2 trial evaluating systemic therapy ± liver-directed RT for advanced intrahepatic cholangiocarcinoma, with broad eligibility for patients who have received at least 4 cycles of gem/cis/durvalumab.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Age > 18
- BMI > 30
- Pathological diagnosis of iCCA with at least one intrahepatic tumor ≥ 3 cm
- Locally advanced unresectable or extrahepatic metastasis (non-regional nodes, lung, bone)
- At least 4 cycles of gemcitabine/cisplatin + durvalumab
- Adequate organ function (Hb ≥ 9, ANC ≥ 1.0, platelets ≥ 75, bilirubin ≤ 1.5x ULN, AST/ALT ≤ 2.5x ULN or ≤ 5x with liver mets, CrCl > 40 mL/min)
- Life expectancy ≥ 12 weeks
- RECIST 1.1 target lesion not previously irradiated
- Willing and able to comply with protocol
- Excludes: unresolved toxicity ≥ Grade 2, active autoimmune, uncontrolled intercurrent illness, prior malignancy within 3 years, brain metastases, QTcf > 470 ms, active hepatitis/HIV, pregnancy/breastfeeding
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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