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    Home > Active Ingredient News > Antitumor Therapy > Liver Cnacer: Efficacy and safety of mTOR inhibitor Temsirolimus combined with sorafenib in the treatment of advanced hepatocellular carcinoma: Phase II clinical study

    Liver Cnacer: Efficacy and safety of mTOR inhibitor Temsirolimus combined with sorafenib in the treatment of advanced hepatocellular carcinoma: Phase II clinical study

    • Last Update: 2021-09-11
    • Source: Internet
    • Author: User
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    The mTOR signaling pathway is up-regulated in nearly half of hepatocellular carcinomas (HCC) and is associated with poor prognosis
    .


    In the preclinical model of HCC, the combination of mTOR pathway inhibition and sorafenib proved the effectiveness of the treatment


    The mTOR signaling pathway is up-regulated in nearly half of hepatocellular carcinomas (HCC) and is associated with poor prognosis


    The study is a single-arm, open phase II study, and patients receive temsirolimus 10 mg/week combined with sorafenib 200 mg Bid
    .


    The primary endpoint of the study was the time from treatment to progression (TTP), and the secondary endpoints were OS, ORR, safety, and AFP response


    The study is a single-arm, open phase II study, and patients receive temsirolimus 10 mg/week combined with sorafenib 200 mg Bid


    TTP can be assessed in 28 patients (97%)


    TTP and OS

    TTP and OS

    No patients achieved complete remission (CR) or partial response (PR)
    .


    21 patients (75%) reached stable disease (SD), and 4 patients (14%) had disease progression (PD)


    No patients achieved complete remission (CR) or partial response (PR)


    ORR

    Of the 28 patients (21%) who can be evaluated for safety, 6 patients had serious adverse events (SAE), and at least 2 patients (7%) had treatment-related SAEs (1 SAE was grade 3 diarrhea) And grade 3 dehydration requires hospitalization; 1 case of SAE is grade 3 cellulitis and grade 2 limb pain requires hospitalization)
    .


    The most common treatment-related AEs of CTCAE grade 3 or higher are hypophosphatemia, thrombocytopenia, and skin rash


    Of the 28 patients (21%) who can be evaluated for safety, 6 patients had serious adverse events (SAE), and at least 2 patients (7%) had treatment-related SAEs (1 SAE was grade 3 diarrhea) And grade 3 dehydration requires hospitalization; 1 case of SAE is grade 3 cellulitis and grade 2 limb pain requires hospitalization)


    AFP response is defined as a decrease of at least 50% in AFP from the baseline level


    The researchers also conducted next-generation sequencing (NGS) for exploratory research.


    NGS Exploration

    In summary, the mTOR inhibitor Temsirolimus combined with sorafenib is safe and tolerable in the treatment of advanced hepatocellular carcinoma, but it did not reach the study endpoint
    .


    NGS analysis of mTOR pathway mutations was not significantly related to tumor treatment response
    .

    In summary, the mTOR inhibitor Temsirolimus combined with sorafenib is safe and tolerable in the treatment of advanced hepatocellular carcinoma, but it did not reach the study endpoint
    .
    NGS analysis of mTOR pathway mutations was not significantly related to tumor treatment response
    .
    The mTOR inhibitor Temsirolimus combined with sorafenib is safe and tolerable in the treatment of advanced hepatocellular carcinoma, but it did not reach the study endpoint
    .
    NGS analysis of mTOR pathway mutations was not significantly related to tumor treatment response
    .
    The mTOR inhibitor Temsirolimus combined with sorafenib is safe and tolerable in the treatment of advanced hepatocellular carcinoma, but it did not reach the study endpoint
    .
    NGS analysis of mTOR pathway mutations was not significantly related to tumor treatment response
    .

    Original source:

    Original source:

    Robin K.
    Kelley, Nancy M.
    Joseph, Halla S.
    Nimeiri, et al.
    Phase II Trial of the Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma with Tumor Mutation Profiling.
    Liver Cancer.
    DOI: 10.
    1159/000518297.
    Published online: September 6, 2021.

    Robin K.
    Kelley, Nancy M.
    Joseph, Halla S.
    Nimeiri, et al.
    Phase II Trial of the Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma with Tumor Mutation Profiling.
    Liver Cancer.
    DOI: 10.
    1159/000518297.
    Published online: September 6, 2021.
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