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P-124 Nivolumab plus ipilimumab as neoadjuvant therapy for potentially resectable hepatocellular carcinoma
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Preoperative use of ICIs in patients with hepatocellular carcinoma has been explored in several small, early-phase studies, in which heterogeneous therapeutic combinations were tested, mainly with safety and feasibility being the primary endpoints assessed.
“Preoperative use of ICIs in patients with hepatocellular carcinoma has been explored in several small, early-phase studies, in which heterogeneous therapeutic combinations were tested, mainly with safety and feasibility being the primary endpoints assessed.7–12”
From Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis (2024) · cites this paper as [12]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredEach clinical trial mandated the assessment of a pathological response as part of their primary or secondary efficacy endpoints, and this assessment was prospectively collected and reported as part of the exploratory aims for all cohorts.
“Each clinical trial mandated the assessment of a pathological response as part of their primary7 or secondary efficacy endpoints,9,11 and this assessment was prospectively collected and reported as part of the exploratory aims for all cohorts.12,18”
From Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis (2024) · cites this paper as [12]
The Results in the P-124 abstract report major pathological response in 5 of 15 patients who underwent surgery. The copy does not say that pathological response was prospectively collected as an exploratory aim or reported for all cohorts; it also does not establish the endpoint requirements of other trials. (LLM, conf=0.82)
Experimental — accuracy not yet measuredThe use of ICIs as neoadjuvant treatment before liver resection for patients with hepatocellular carcinoma has been explored in several single-centre phase 1 and 2 clinical trials.
“The use of ICIs as a neoadjuvant treatment before liver resection for patients with hepatocellular carcinoma has been explored in several single-centre phase 1 and 2 clinical trials.”
From Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis (2024) · cites this paper as [12]
The Abstract (page not provided) describes a clinical study of nivolumab plus ipilimumab as neoadjuvant treatment for potentially resectable hepatocellular carcinoma; fifteen participants underwent surgery. It does not state the study’s phase or whether it was single-centre, and this one study does not establish that several such trials were conducted. (LLM, conf=0.82)
Experimental — accuracy not yet measuredThese pioneering studies have shown the safety and feasibility of a perioperative ICI treatment approach.
“Collectively, these pioneering studies have shown the safety and feasibility of a perioperative ICI treatment approach.7–12,25”
From Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis (2024) · cites this paper as [12]
The Abstract concludes that neoadjuvant nivolumab plus ipilimumab is feasible for patients with potentially resectable hepatocellular carcinoma, and reports that 15 patients underwent surgery. It reports safety outcomes, including grade 3–4 adverse events in 12 of 29 patients, but does not conclude that this perioperative approach was safe. (LLM, conf=0.82)
Experimental — accuracy not yet measuredThis study from the NeoHCC consortium was designed to overcome the issue of underpowered individual studies by pooling prospectively collected patient-level data from phase 1 and 2 clinical trials run in a consortium of tertiary referral centres.
“This study from the NeoHCC consortium was designed to overcome this issue by pooling prospectively collected patient-level data from phase 1 and 2 clinical trials run in a consortium of tertiary referral centres.7,9,11,12”
From Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis (2024) · cites this paper as [12]
Split into 2 atoms — 0 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
None of these studies were individually powered to robustly investigate predictive factors of efficacy from neoadjuvant ICI therapy, particularly long-term survival outcomes including relapse-free survival.
“However, none of these studies were individually powered to robustly investigate predictive factors of efficacy from neoadjuvant ICI therapy, particularly with regards to long-term survival outcomes, including relapse-free survival.”
From Pathological response following neoadjuvant immune checkpoint inhibitors in patients with hepatocellular carcinoma: a cross-trial, patient-level analysis (2024) · cites this paper as [12]
The Abstract (page unavailable) reports 29 enrolled patients and says long-term follow-up is needed to clarify whether treatment reduces recurrence after surgery. That supports the concern about immature long-term outcomes, but it does not state that the study was underpowered to investigate predictive factors or report relapse-free survival; it reports an exploratory gene-expression association with progression-free survival instead. (LLM, conf=0.78)
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D'Alessio, A., Stefanini, B., Blanter, J., Adegbite, B., Crowley, F., Yip, V., Slater, S., Fulgenzi, C. A. M., Celsa, C., Manfredi, G. F., et al. (2024) · The Lancet Oncology · doi:10.1016/s1470-2045(24)00457-1 · Cited by 90
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Metadata
- Authors
- Su, Y., Lin, Y., Hsiao, C., Ou, D., Chen, S., Wu, Y., Lee, W., Lin, J., Hsu, C., Ho, M., Lu, L., Wu, T., Lai, S., Chao, Y., Chou, T., Yen, C., Chen, L., Shan, Y., Cheng, A., & Hsu, C.
- Affiliations
- National Health Research Institutes (TW)
- National Cheng Kung University Hospital (TW)
- National Taiwan University (TW)
- Taipei Veterans General Hospital (TW)
- National Taiwan University Hospital (TW)
- Chang Gung Memorial Hospital (TW)
- Mackay Memorial Hospital (TW)
- Tri-Service General Hospital (TW)
- Kaohsiung Medical University Chung-Ho Memorial Hospital (TW)
- ORCID
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2021-07
- Volume
- 32
- Pages
- S141
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W3196115239
- Cited by
- 11
- References
- 0
- Citations by year
- 2025: 2 · 2024: 3 · 2023: 4 · 2022: 1 · 2021: 1
- Type
- conference abstract
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- Funders
- Meso Scale Diagnostics (BMS/ ONO)
- Eli Lilly and Company
- Topics
- Health Sciences › Medicine › Hepatology › Hepatocellular Carcinoma Treatment and Prognosis
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Epidemiology › Hepatitis B Virus Studies
- Keywords
- nivolumab, ipilimumab, neoadjuvant therapy, hepatocellular carcinoma, immune checkpoint inhibitors, combination immunotherapy, curative surgery
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