Dataset Information

Combining stereotactic body radiotherapy with camrelizumab for unresectable hepatocellular carcinoma: a single-arm trial.

ABSTRACT:

Purpose

Stereotactic body radiotherapy (SBRT) may have significant immunomodulatory effects that enhance tumor response to immune checkpoint inhibitors. This phase 2 clinical trial was conducted to evaluate the safety and efficacy of combining palliative SBRT with camrelizumab (an anti-PD1 monoclonal antibody) in patients with unresectable hepatocellular carcinoma (uHCC).

Methods

Patients with uHCC, Child-Pugh A/B liver function, and at least one measurable lesion were enrolled between April 2020 and August 2022. Patients were administered 200 mg camrelizumab intravenously from the first day of palliative SBRT and then every 3 weeks. Palliative SBRT was delivered daily over five fractions per week, with a dose range of 30-50 Gy. The primary endpoints were objective response rate (ORR) and safety. This trial was registered at ClinicalTrials.gov (NCT04193696).

Results

Twenty-one patients were enrolled; the median radiation dose was 40 Gy, and the median number of cycles of camrelizumab was five. The ORR was 52.4%. After a median follow-up of 19.7 months, the median progression-free and overall survival were 5.8 and 14.2 months, respectively. The overall survival probability was 85.7% at 6 months, 76.2% at 9 months, and 59.9% at 12 months. All grade 3 treatment-related adverse events (TRAEs) occurred in five patients (23.8%) and were manageable. No grade 4/5 TRAEs were observed.

Conclusion

Palliative SBRT plus camrelizumab showed promising antitumor activity against uHCC. Toxicities were manageable with no unexpected safety issues. This study provides evidence of a new therapeutic method for the treatment of uHCC.

SUBMITTER: Li JX

PROVIDER: S-EPMC9525355 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Combining stereotactic body radiotherapy with camrelizumab for unresectable hepatocellular carcinoma: a single-arm trial.

Li Jian-Xu JX Su Ting-Shi TS Gong Wen-Feng WF Zhong Jian-Hong JH Yan Liu-Ying LY Zhang Jie J Li Li-Qing LQ He Mei-Ling ML Zhang Rui-Jun RJ Du You-Qin YQ Wang Xiao-Ting XT Liang Shi-Xiong SX Xiang Bang-De BD

Hepatology international 20220824 5

<h4>Purpose</h4>Stereotactic body radiotherapy (SBRT) may have significant immunomodulatory effects that enhance tumor response to immune checkpoint inhibitors. This phase 2 clinical trial was conducted to evaluate the safety and efficacy of combining palliative SBRT with camrelizumab (an anti-PD1 monoclonal antibody) in patients with unresectable hepatocellular carcinoma (uHCC).<h4>Methods</h4>Patients with uHCC, Child-Pugh A/B liver function, and at least one measurable lesion were enrolled be ...[more]

PMID: 36001228

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Project description:BackgroundThe synergistic effect of locoregional therapy in combination with systemic therapy as a conversion therapy for unresectable hepatocellular carcinoma (uHCC) is unclear. The purpose of this study was to evaluate the efficacy and safety of transcatheter arterial chemoembolisation (TACE) combined with lenvatinib and camrelizumab (TACE + LEN + CAM) as conversion therapy for uHCC.MethodsThis single-arm, multicentre, prospective study was conducted at nine hospitals in China. Patients (aged 18-75 years) diagnosed with uHCC, an Eastern Cooperative Oncology Group performance score (ECOG-PS) of 0-1 and Child-Pugh class A received camrelizumab (200 mg, every 3 weeks) and lenvatinib (bodyweight ≥60 kg: 12 mg/day; <60 kg: 8 mg/day) after TACE treatment. Surgery was performed after tumour was assessed as meeting the criteria for resection. Patients who did not meet the criteria for surgery continued to receive triple therapy until disease progression or intolerable toxicity. Primary endpoints were objective response rate (ORR) according to the modified Response Evaluation Criteria in Solid Tumours (mRECIST) and safety. Secondary endpoints included the surgical conversion rate, radical (R0) resection rate, and disease control rate (DCR). This study was registered with Chinese Clinical Trial Registry (ChiCTR2100050410).FindingsBetween Oct 25, 2021, and July 20, 2022, 55 patients were enrolled. As of the data cutoff on June 1, 2023, the median follow-up was 13.3 months (IQR 10.6-15.9 months). The best tumour response to triple therapy was complete response (CR) in 9 (16.4%) patients, partial response (PR) in 33 (60.0%) patients, stable disease (SD) in 5 (9.1%) patients, or progressive disease (PD) in 7 (12.7%) patients. The ORR was 76.4% (42/55, 95% CI, 65.2-87.6%), and the DCR was 85.5% (47/55, 95% CI, 76.2-94.8%) per mRECIST. Twenty-four (43.6%) of the 55 patients suffered from grade 3-4 treatment-related adverse events (TRAEs). No grade 5 TRAEs occurred. A total of 30 (30/55, 54.5%) patients were converted to resectable HCC and 29 (29/55, 52.7%) patients underwent resection. The R0 resection rate was 96.6% (28/29). The major pathologic response (MPR) and pathologic complete response (pCR) rates in the surgery population were 65.5% (19/29) and 20.7% (6/29), respectively. Only one patient developed a Clavien-Dindo IIIa complication (abdominal infection). No Clavien-Dindo IIIb-V complications occurred. The median OS and median PFS were not reached.InterpretationThe triple therapy (TACE + LEN + CAM) is promising active for uHCC with a manageable safety. Moreover, triple therapy has good conversion efficiency and the surgery after conversion therapy is feasible and safe. To elucidate whether patients with uHCC accepting surgical treatment after the triple therapy can achieve better survival benefits than those who receive triple therapy only, well-designed randomised controlled trials are needed.FundingThis study was funded by the Natural Science Foundation of Fujian Province, China (2022J01691) and the Youth Foundation of Fujian Province Health Science and Technology Project, China (2022QNA035).

Project description:BackgroundHepatocellular carcinoma (HCC) poses a significant challenge for patients ineligible for surgical resection or liver transplantation. Local therapies like Stereotactic Body Radiotherapy (SBRT) are crucial for those with liver-limited disease. Insulin-like growth factor-1 (IGF-1) is a potential biomarker for liver function. This study evaluates IGF-1's prognostic value in predicting survival outcomes in HCC patients undergoing SBRT.MethodsWe analyzed 42 HCC patients treated with SBRT between May 2021 and January 2024, with IGF-1 levels measured within four weeks before SBRT. Patient demographics, tumor metrics, and clinical outcomes were examined. The prognostic significance of IGF-1 was assessed using Cox proportional hazards and ROC curve analysis to determine optimal IGF-1 cutoffs for survival prediction. A nomogram predicting 1-year and 2-year survival was constructed using a multivariate Cox model.ResultsIGF-1 levels were significantly lower in patients with cirrhosis or sarcopenia. Median overall survival (OS) was 24 months, with a significant survival difference favoring patients with IGF-1 levels above 62.4 ng/ml (Hazard Ratio [HR]: 5.9, P = 0.0025). A multivariable Cox model including Child-Turcotte-Pugh (CTP) score, IGF-1, and tumor volume effectively predicted survival. IGF-1 and tumor volume significantly impacted OS (HR: 6.9 and 1.004, p = 0.014 and 0.0022, respectively). Integrating IGF-1 with CTP score improved predictive accuracy (c-index 0.66 to 0.75, p = 0.052).The nomogram, integrating IGF-1 with the CTP and tumour volume, exhibited robust predictive accuracy with an area under the curve (AUC) of 0.84 for 2-year survival.ConclusionIGF-1 is a reliable biomarker for liver function and survival prediction in HCC patients undergoing SBRT. Higher IGF-1 levels indicate better prognosis. The developed nomogram, incorporating IGF-1, enhances clinical decision-making for SBRT management. Further validation in larger cohorts is needed.

Project description:Stereotactic body radiotherapy (SBRT) is a novel noninvasive treatment for hepatocellular carcinoma. SBRT can achieve effective local control, but it requires a relatively high input of resources; this systematic review was performed to assess the cost effectiveness of SBRT in the treatment of hepatocellular carcinoma to provide a basis for government pricing and medical insurance decision-making. The PubMed, EMBASE, Cochrane Library, CNKI, Wanfang and SinoMed databases were searched to collect economic evaluations of SBRT for the treatment of hepatocellular carcinoma from the date of database inception through December 31, 2018. Two reviewers independently screened the studies, extracted the data and performed a descriptive analysis of the basic characteristics, methods of economic evaluation and main results, as well as the quality and heterogeneity of the reports. A total of 5 studies were included. Among them, the level of heterogeneity was relatively acceptable, with a median score of 90%. Four studies were cost-utility analyses (CUAs), and 1 was a cost-effectiveness analysis (CEA). The incremental cost effectiveness ratio (ICER) for sorafenib compared to SBRT was US $114,795 per quality-adjusted life year gained (cost/QALY) in patients with advanced hepatocellular carcinoma. The ICER for proton beam therapy compared to SBRT was US $6465 in patients with inoperable advanced hepatocellular carcinoma. The ICER for SBRT compared to RFA was US $164,660 for patients with unresectable colorectal cancer (CRC) with liver metastases and US $56,301 for patients with early-stage hepatocellular carcinoma. For patients with inoperable localized hepatocellular carcinoma, compared with RFA-SBRT therapy, the ICERs for SBRT-SBRT and SBRT-RFA were US $558,679 and US $2197,000, respectively; RFA-RFA was dominated. In conclusion, there is limited evidence suggesting that SBRT could be cost-effective for highly specific subpopulations of HCC patients, and further economic evaluations based on randomized controlled trials (RCTs) or cohort studies are needed.

Dataset Information

Combining stereotactic body radiotherapy with camrelizumab for unresectable hepatocellular carcinoma: a single-arm trial.

Purpose

Methods

Results

Conclusion

Publications

Combining stereotactic body radiotherapy with camrelizumab for unresectable hepatocellular carcinoma: a single-arm trial.

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