Trial reportInvestigational new drugs2015
A phase II trial of bevacizumab plus temsirolimus in patients with advanced hepatocellular carcinoma.
Trial report in Investigational new drugs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 31 citations in OpenAlex.
- Phase I study of bevacizumab and temsirolimus combination therapy in advanced malignancies: safety, efficacy, and ovarian cancer expansion.The oncologist · 2026Article
- mTOR Signaling: Roles in Hepatitis B Virus Infection and Hepatocellular Carcinoma.International journal of biological sciences · 2024Review
- Potential Molecular Targeted Therapy for Unresectable Hepatocellular Carcinoma.Current oncology (Toronto, Ont.) · 2023Review
- Targeting LRRC41 as a potential therapeutic approach for hepatocellular carcinoma.Frontiers in molecular biosciences · 2023Article
- Clinically approved combination immunotherapy: Current status, limitations, and future perspective.Current research in immunology · 2022Review
- Targeting the PI3K/Akt/mTOR Pathway in Hepatocellular Carcinoma.Biomedicines · 2021Review
- Role of the Mammalian Target of Rapamycin Pathway in Liver Cancer: From Molecular Genetics to Targeted Therapies.Hepatology (Baltimore, Md.) · 2021Review
- Advances of Targeted Therapy for Hepatocellular Carcinoma.Frontiers in oncology · 2021Review
- Article
- Hepatocellular Carcinoma: Review of Targeted and Immune Therapies.Journal of gastrointestinal cancer · 2018Review
- Matrine inhibits the invasive and migratory properties of human hepatocellular carcinoma by regulating epithelial‑mesenchymal transition.Molecular medicine reports · 2018Article
- Current biologics for treatment of biliary tract cancers.Journal of gastrointestinal oncology · 2017Review
- Recent advances in hepatocellular carcinoma therapy.Pharmacology & therapeutics · 2017Review
- Molecular targeting of VEGF/VEGFR signaling by the anti-VEGF monoclonal antibody BD0801 inhibits the growth and induces apoptosis of human hepatocellular carcinoma cells in vitro and in vivo.Cancer biology & therapy · 2017Article
- Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L.Journal of hepatocellular carcinoma · 2017Article
- Combination treatment including targeted therapy for advanced hepatocellular carcinoma.Oncotarget · 2016Review
- Advanced Hepatocellular Cancer: the Current State of Future Research.Current treatment options in oncology · 2016Review
- Hepatocellular carcinoma: Will novel targeted drugs really impact the next future?World journal of gastroenterology · 2016Review
- A phase I trial of ANG1/2-Tie2 inhibitor trebaninib (AMG386) and temsirolimus in advanced solid tumors (PJC008/NCI♯9041).Investigational new drugs · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 10 institutions in 2 countries.
Funding
Abstract
backgroundThere is strong rationale to combine temsirolimus (TEM) with Bevacizumab (BEV) for patients with advanced HCC.
methodsA modified two-stage Simon phase II trial was performed with plans to advance to stage 2 if more than 2 patients had confirmed PR or >18 patients were progression free at 6 months out of 25 in stage 1. Toxicity, PFS and overall survival were secondary endpoints. Eligible pts had advanced HCC, Child Pugh A liver status and no prior systemic therapy involving the VEGF or m-TOR targeted agents. Patients were treated with temsirolimus 25 mg IV on Days 1, 8, 15, and 22 of a 28 day cycle and bevacizumab 10 mg/kg IV on Days 1 and 15 of the cycle.
resultsTwenty-eight eligible patients were enrolled, 26 evaluable receiving a median of 6.5 cycles (range 1-18). Drug related toxicities were common including cytopenias, fatigue, mucositis, diarrhea and mild bleeds. Dose reductions or discontinuation of TEM were common. Accrual closed for presumed futility after interim analysis of the first 25 evaluable patients showed only one PR and 16/25 were progression-free at 6 months. However, the final data update in March 2013 demonstrated 4 confirmed PRs, a 5th unconfirmed PR and 16 /26 progression-free at 6 months. Median PFS and OS were 7 and 14 months respectively.
conclusionThis first-line HCC trial evaluating the BEV/TEM doublet reports an ORR of 19 % and OS of 14 months which is favorable but requires further study at a more optimized dose and schedule.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.