SBRT in HCC With Oligoprogression on First-line Immunotherapy

NCT06434480 | Recruiting

• 1 other identifier: HCC078
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

HCC is a huge healthcare burden in Hong Kong and is one of the top 5 cancers in terms of incidence and mortality in Hong Kong. Patients with advanced HCC are treated with immunotherapy-based as first-line treatment as a standard of care. At the moment, there is limited evidence to guide subsequent treatments after patients progressed on immunotherapy. Oligoprogression is a term used to describe patients who had limited progression (usually less than 3 sites) on systemic therapy, with the rest of the lesions controlled. Previous studies in non-HCCs have shown that addition of locoregional treatment (e.g. radiotherapy) may prolong the use of systemic therapy, resulting in improved survival, but this has been relatively unexplored for HCC. In this prospective, single-arm study, we aim to evaluate the treatment outcome, efficacy and safety of the addition of radiotherapy to oligoprogressive sites for patients who had limited progression on First-line Immunotherapy.

Conditions

HCC

Keywords

SBRT in HCC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) with the addition of SBRT to oligo-progressive sites

  2 years

Secondary Outcomes (5)

• Overall survival (OS)

  2 years

• Objective response rates (ORR) of the irradiated lesion(s)

  2 years

• Overall objective response rates (ORR)

  2 years

• Additional treatment related adverse events (TRAE)

  2 years

• Pattern of progression

  2 years

Study Arms (1)

Radiotherapy

EXPERIMENTAL

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)

Interventions

Stereotactic Body Radiation Therapy (SBRT) RADIATION

* For intrahepatic progression: 27.5-50Gy in 5 fractions over 2 weeks is generally recommended. * For extrahepatic progression: delivery of ablative dose will be attempted.

Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years old
• ECOG performance 0 to 1
• Confirmed diagnosis of HCC
• Oligoprogression on first-line immunotherapy, as defined as ≤ 5 lesions (intra- and extrahepatic lesions all together; vascular tumor thrombus is counted as one lesion)
• First-line immunotherapy that are allowed in this study include atezolizumab plus bevacizumab, durvalumab plus tremelimumab, durvalumab, nivolumab and ipilimumab, which are approved by the FDA and have been used in Hong Kong.
• Progressed lesion(s) amenable to SBRT:
• For intrahepatic progression:
• Number of intrahepatic progression ≤ 5
• Total intrahepatic tumours ≤ 10
• Maximum sum of HCC ≤ 20cm
• Any one HCC ≤ 20cm
• Normal liver volume minus intrahepatic GTV \> 700cc
• Mean liver dose ≤ 15Gy
• No measurable common or main branch biliary duct involvement
• No direct tumor invasion into the stomach, duodenum, small bowel or large bowel

You may not qualify if:

• History of another malignancy except appropriately-treated BCC of skin or CIN of cervix during the last 5 years
• Previous radiotherapy to the abdomen
• Previous yttrium-90 chemoembolization
• Pregnant or lactating females at any time during the study
• Active autoimmune disease requiring systemic therapy in the past 2 years
• Diagnosis of immunodeficiency (including HIV)
• Ongoing corticosteroid therapy \>10mg prednisone daily

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Landon L CHAN, MBChB, MSc

CONTACT

3505 1042; landon.chan@cuhk.edu.hk

Natalie KWONG, RN

CONTACT

3505 1040; nataliekwong019@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 30, 2024
• Study Start: June 21, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)