Background
Intrahepatic cholangiocarcinoma (CCA) is amongst the most common primary liver tumors worldwide. CCA carries a bad prognosis prompting research to establish new treatment modalities other than surgery and the current chemotherapeutic regimens adopted. Hence, this trial explores a new therapeutic approach, to combine stereotactic body radiation therapy (SBRT) and immunotherapy (Nivolumab), and asses its clinical benefit and safety profile after induction chemotherapy in CCA.
Methodology
This is a Phase II open-label, single-arm, multicenter study that investigates Nivolumab (PD-1 inhibitor) treatment at Day 1 followed by SBRT (30 Gy in 3 to 5 fractions) at Day 8, then monthly Nivolumab in 40 patients with non-resectable locally advanced, metastatic or recurrent intrahepatic or extrahepatic CCA. Eligible patients were those above 18 years of age with a pathologically and radiologically confirmed diagnosis of non-resectable locally advanced or metastatic or recurrent intrahepatic or extrahepatic CCA, following 4 cycles of cisplatin-based chemotherapy with an estimated life expectancy of more than 3 months, among other criteria. The primary endpoint is the progression free survival (PFS) rate at 8 months and disease control rate (DCR). The secondary endpoints are overall survival (OS), tumor response rate (TRR), duration of response, evaluation of biomarkers: CD3 + , CD4 + and CD8 + T cell infiltration, as well as any change in the PD-L1 expression through percutaneous core biopsy when compared with the baseline biopsy following 1 cycle of Nivolumab and SBRT.
Discussion
SRBT alone showed promising results in the literature by both inducing the immune system locally and having abscopal effects on distant metastases. Moreover, given the prevalence of PD-L1 in solid tumors, targeting it or its receptor has become the mainstay of novel immunotherapeutic drugs use. A combination of both has never been explored in the scope of CCA and that is the aim of this study.
Trial registration
ClinicalTrials.gov NCT04648319,
April 20, 2018.
BACKGROUND: Spinal cord injury (SCI) is a permanent disability which negatively affects individuals' health and particularly their quality of life. OBJECTIVE: To assess the quality of life (QoL) among Lebanese men with spinal cord injury and to compare it to a healthy control group. METHODS: A case control study was conducted. Fifty-one Lebanese patients with spinal cord injury and 51 age-sexmatched healthy persons were included in the study. RESULTS: Compared to healthy controls, the mean scores of eight domains of SF-36 were significantly lower in SCI group: physical functioning (PF) (26.5 vs 87; p value <0.0001), role limitations due to physical (RP) (57.8 vs 93.6; p value <0.0001), bodily pain (BP) (60.5 vs 90.7; p value, 0.0001), general health (GH) (49.5 vs 76.6; p value <0.0001), vitality (VT) (51.2 vs 71.3; p value <0.0001), social functioning (SF) (68.9 vs 91.2; p value <0.0001), role limitations due to emotional problems (RE) (71.2 vs 91.5; p value 0.003) and mental health (MH) (62.9 vs 79; p value <0.0001). Concerning PCS and MCS scores, SCI patients reported significantly lower scores than control group (p value <0.0001). CONCLUSION: Participants with SCI reported reduced QoL in comparison with normal individuals.
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