A multicentric national phase II trial assessing TIslelizumab in monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2 liver function score: The UCGI 41 HESTIA TRIAL DESIGN AND PRELIMINARY SAFETY Data.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
환자: advanced HCC present with Child-Pugh B liver functions
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
This is a single-arm phase 2 study.
[BACKGROUND] Hepatocellular carcinoma (HCC) frequently develops in underlying cirrhosis.
APA
Bourien H, Adhoute X, et al. (2025). A multicentric national phase II trial assessing TIslelizumab in monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2 liver function score: The UCGI 41 HESTIA TRIAL DESIGN AND PRELIMINARY SAFETY Data.. Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 57(10), 2011-2015. https://doi.org/10.1016/j.dld.2025.07.019
MLA
Bourien H, et al.. "A multicentric national phase II trial assessing TIslelizumab in monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2 liver function score: The UCGI 41 HESTIA TRIAL DESIGN AND PRELIMINARY SAFETY Data.." Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, vol. 57, no. 10, 2025, pp. 2011-2015.
PMID
40752979 ↗
Abstract 한글 요약
[BACKGROUND] Hepatocellular carcinoma (HCC) frequently develops in underlying cirrhosis. Liver dysfunction impacts survival and may influence treatment results. About a quarter of patients with advanced HCC present with Child-Pugh B liver functions. All recent phase 3 trials validating standard of care limited inclusion to patients with Child-Pugh A liver function. Results of immunotherapy is less described in patients with altered liver function. We previously showed that the ALBI grade might be able to better select patients with Child-Pugh B liver functions who could benefit from sorafenib. Single-agent anti-PD-(L)1 antibodies might have a more favorable safety profile than standard of care combinations.
[METHODS] We thus launched a study, the HESTIA trial, testing tislelizumab, an anti-PD-1 antibody that was demonstrated as non-inferior to sorafenib as first-line treatment, in the population of patients with advanced HCC, Child-Pugh B and ALBI grade 1 or 2 liver function.
[RESULTS] In this article, we present the design of the study and first safety results. This is a single-arm phase 2 study. Fifty patients will be included. The primary endpoint is objective response rate. The first safety analysis showed no signal of increased toxicity of the drugs. However, this population is at high risk for liver-related adverse events.
[CONCLUSION] The study is currently pursuing accrual.
[METHODS] We thus launched a study, the HESTIA trial, testing tislelizumab, an anti-PD-1 antibody that was demonstrated as non-inferior to sorafenib as first-line treatment, in the population of patients with advanced HCC, Child-Pugh B and ALBI grade 1 or 2 liver function.
[RESULTS] In this article, we present the design of the study and first safety results. This is a single-arm phase 2 study. Fifty patients will be included. The primary endpoint is objective response rate. The first safety analysis showed no signal of increased toxicity of the drugs. However, this population is at high risk for liver-related adverse events.
[CONCLUSION] The study is currently pursuing accrual.
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
- Humans
- Carcinoma
- Hepatocellular
- Liver Neoplasms
- Antibodies
- Monoclonal
- Humanized
- Liver Function Tests
- Male
- Sorafenib
- Female
- Middle Aged
- Aged
- Clinical Trials
- Phase II as Topic
- Treatment Outcome
- Multicenter Studies as Topic
- Albi score
- Anti-PD-1
- hepatocellular
- Child B
- Immune checkpoint inhibitors
- Immunotherapy
- Liver function
🏷️ 같은 키워드 · 무료전문 — 이 논문 MeSH/keyword 기반
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