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NCT06434480

SBRT in HCC With Oligoprogression on First-line Immunotherapy

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)
Track this trial

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 35 words
    • Enrollment reduced: 30 → 27 participants
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Eligibility criteria revisedv5
  3. Eligibility criteria expanded, about 20 words
    • Study title expanded, about 1 word
    v4
  4. Site contact updatedv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2, 2024 to Jun 21, 2024
    • Site details revised
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression-free survival (PFS) with the addition of SBRT to oligo-progressive sites
Timeframe: 2 years

Secondary (5)

Overall survival (OS)
Objective response rates (ORR) of the irradiated lesion(s)
Overall objective response rates (ORR)
Additional treatment related adverse events (TRAE)
Pattern of progression

Arms and interventions

RadiotherapyExperimental

Suitable patients are consented and enrolled with the following treatment being given. * Continue of immunotherapy till next progression, intolerability, or death as per standard practice. * Radiotherapy will start 4 to 6 weeks after consent * For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks is generally recommended. * For extrahepatic progression: delivery of ablative dose (i.e. BED10≥100Gy) will be attempted. * Lower doses to be delivered (for both intrahepatic and extrahepatic lesions) based on nearby OAR dose constraints are allowed. The final dose and fractionation are at the discretion of the treating oncologist. * Bevacizumab will need to be withhold 4 weeks prior and after radiotherapy. PD-1 or PD-L1 therapy are allowed to be continued as per the latest ESTRO-ESMO consensus guideline. * Dose constraints to organ at risk (OAR) will take reference from RTOG-1112 and UK 2022 consensus on normal tissue dose-volume constraints and ASTRO 2022 guideline.

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Sites

1 site in 1 country

  • Department of Clinical Oncology, Prince of Wales HospitalHong Kong, Hong Kong