LOBAR + PVT.
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LOBAR + PVT

Cancer Therapies & Ablation / TheraSphere / Proven Results / LOBAR + PVT
 

Lobar + PVT: DOSISPHERE-01 Trial Summary


Level 1 evidence of 26.7 month overall survival for HCC patients treated with TheraSphere using personalized dosimetry compared to 10.7 months with standard single compartment dosimetry.

Study Objective Multi-center, prospective, randomized, investigator-sponsored phase II trial designed to compare the clinical outcomes of SIRT with TheraSphere in patients with advanced HCC using two pre-treatment dosimetry determination methods: (1) Standard, single-compartment dosimetry (SDA); defined as a uniform distribution of absorbed dose within the perfused volume – both tumor and normal liver or (2) Personalized dosimetry (PDA); defined as multi-compartment Y-90 distribution of absorbed dose within the perfused volume that accounts for preferential blood flow into the tumor compared with normal parenchyma.

Primary Endpoint Response rate of the index lesion at Month 3 according to EASL criteria using a mITT population* by investigator assessment.

Main Secondary Endpoints Overall Survival | PFS | Dose-response relationship | Safety

*mITT: randomized and treated patients

 

Study Design


Multi-centre, randomized (1:1), prospective, phase II study

Multi-centre, randomized (1:1), prospective, phase II study.

Median Overall Survival (ITT population)

(Investigator Assessment)
Median Overall Survival (ITT population)

Median Overall Survival based on TD

(Investigator Assessment)
Median Overall Survival based on TD

 

DOSISPHERE-01 Trial Summary


12 month results

PATIENT
DEMOGRAPHICS

(mITT population)
PATIENT DEMOGRAPHICS (mITT population)
*No significant difference in baseline characteristics between groups

TREATMENT CHARACTERISTICS AND DOSIMETRY

(mITT population)
TREATMENT CHARACTERISTICS AND DOSIMETRY (mITT population)
*AD=absorbed dose

 

Primary Endpoint


Index Lesion Response Rate at 3 Months Using EASL in the mITT Population

Primary Endpoint.

* reasons for censoring: received another anti-cancer treatment before M3 evaluation (n=2), no evaluation at M3 evaluation (n=1) (10.7%)

** reasons for censoring: Early deaths (before M3) (n=2), no evaluation at M3 (n=1), start another anti-cancer treatment before M3 evaluation (n=1) (14.3%)

 

Liver Adverse Events


(Grade ≥3) Related to Y-90*

  PAD (n=35) SDA (N=21)
Patients with ≥ 1 AE 3 (8.6%) 3 (14.3%)
Death 1 (2.9%) 1 (4.8%)
Liver AEs 4 (11.4%) 5 (23.8%)
  Ascites 1 (2.9%) 1 (4.8%)
  Encephalopathy 0 0
  GI hemorrhage 0 2 (4.8%)
  Bilirubin increase/jaundice 1 (2.9%) 2 (9.5%)
  Hepatic failure 2 (5.7%) 0
* patients allocated to either PDA or SDA based on treatment received (dose received) versus allocation by randomization
 

 

PI-750208-AB

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