Liver Metastasis Clinical Trial
— LiMeTOfficial title:
Advanced Immune Gene and Cell Therapies for Liver Metastases
NCT number | NCT04622423 |
Other study ID # | LiMeT |
Secondary ID | 22737 |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 6, 2019 |
Est. completion date | June 30, 2026 |
Liver metastases (MTS) are the main cause of death for patients affected by colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC), thus representing the major unmet clinical need for these malignancies. Based on preliminary and published data, the investigators hypothesize that innovative immune, gene and cell therapy approaches might overcome the tolerogenic liver microenvironment and represent powerful therapeutic tools for liver MTS of PDAC and CRC. The investigators have therefore planned an observational clinical study to enroll distinct cohorts of patients (i.e., metastatic CRC, metastatic and non-metastatic PDAC) and finely characterize, through integrated state-of-the-art -omics, the immune and non-immune microenvironment of their primary tumor and/or liver metastases as well as correlate changes in the activation status and phenotype of peripheral blood leukocytes. Healthy volunteers will be enrolled as negative controls. The investigators aim at identifying: i) actionable tumor associated antigens (TAAs) and local immune suppressive and regulatory pathways; ii) biological parameters for early diagnosis of relapse; iii) the effect of therapies on the shaping of anti-tumor immune responses. Data collected will be instrumental for the generation of novel advanced therapy medicinal products (ATMPs). Indeed, this protocol is part of a multi-partner translational program, supported by the AIRC 5 per Mille 2019 grant, focused on the development, validation and implementation for clinical testing of ATMPs to ameliorate the cure of CRC and PDAC and possibly help the study of other solid tumors. Moreover, the systematic and long-term follow-up of enrolled patients will possibly point at early predictors of differential prognosis and patients' categories eligible for tailored therapies, including those with the novel ATMPs.
Status | Recruiting |
Enrollment | 475 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion and exclusion criteria - CRC patients Inclusion criteria: 1. Patients with histologically or cytologically confirmed diagnosis of CRC metastatic to the liver (stage IV disease, AJCC) 2. Patients with indication to surgical resection and/or chemotherapy treatment 3. Age =18 4. ECOG PS 0-1 at enrollment 5. Written informed consent 6. Patients will be treated in IRCCS San Raffaele Exclusion criteria: 1. Pregnancy or lactation 2. Inability to provide a written informed consent 3. Extraepatic disease with the exception of selected cases in which the coexistence of extrahepatic disease does not constitute an exclusion criterion for hepatic resective surgery (for example in patients with extraepatic lesions in remission or in any case stabilized by chemotherapy) 4. Severe comorbidities (e.g. cardiac diseases, history of psychiatric disabilities, HIV, autoimmune disorders) 5. Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy 6. Other conditions (medical or psychiatric) that in the judgment of Investigators would make the patient an inappropriate candidate for the study Inclusion and exclusion criteria - PDAC patients Inclusion criteria: 1. Patients with clinical/radiological diagnosis/suspicious of pancreatic adenocarcinoma metastatic to the liver, with subsequent cytological/histological confirmation (stage IV disease, AJCC) 2. Age =18 3. Karnofsky performance status =50 4. Metastatic pancreatic adenocarcinoma patients with histological specimens from whole liver metastasis biopsy or core liver biopsy collected at IRCCS San Raffaele and stored in the institutional biobank Centro Risorse Biologiche (CRB-OSR) 5. Written Informed consent 6. Patients with clinical/radiological diagnosis of not metastatic primary PDAC that will undergo pancreatic resection at IRCCS San Raffaele Exclusion criteria: 1. Severe comorbidities (e.g., cardiac diseases, history of psychiatric disabilities) representing an absolute contraindication for whole or core liver metastasis biopsy 2. Pregnancy or lactation 3. Inability to provide a written informed consent 4. Metastatic pancreatic adenocarcinoma patients enrolled in other research trials entailing the analysis of the liver metastasis histological sample |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS San Raffaele | Milan |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele | Università Vita-Salute San Raffaele |
Italy,
Balachandran VP, Luksza M, Zhao JN, Makarov V, Moral JA, Remark R, Herbst B, Askan G, Bhanot U, Senbabaoglu Y, Wells DK, Cary CIO, Grbovic-Huezo O, Attiyeh M, Medina B, Zhang J, Loo J, Saglimbeni J, Abu-Akeel M, Zappasodi R, Riaz N, Smoragiewicz M, Kelley ZL, Basturk O; Australian Pancreatic Cancer Genome Initiative; Garvan Institute of Medical Research; Prince of Wales Hospital; Royal North Shore Hospital; University of Glasgow; St Vincent's Hospital; QIMR Berghofer Medical Research Institute; University of Melbourne, Centre for Cancer Research; University of Queensland, Institute for Molecular Bioscience; Bankstown Hospital; Liverpool Hospital; Royal Prince Alfred Hospital, Chris O'Brien Lifehouse; Westmead Hospital; Fremantle Hospital; St John of God Healthcare; Royal Adelaide Hospital; Flinders Medical Centre; Envoi Pathology; Princess Alexandria Hospital; Austin Hospital; Johns Hopkins Medical Institutes; ARC-Net Centre for Applied Research on Cancer; Gonen M, Levine AJ, Allen PJ, Fearon DT, Merad M, Gnjatic S, Iacobuzio-Donahue CA, Wolchok JD, DeMatteo RP, Chan TA, Greenbaum BD, Merghoub T, Leach SD. Identification of unique neoantigen qualities in long-term survivors of pancreatic cancer. Nature. 2017 Nov 23;551(7681):512-516. doi: 10.1038/nature24462. Epub 2017 Nov 8. — View Citation
Cortesi F, Delfanti G, Grilli A, Calcinotto A, Gorini F, Pucci F, Luciano R, Grioni M, Recchia A, Benigni F, Briganti A, Salonia A, De Palma M, Bicciato S, Doglioni C, Bellone M, Casorati G, Dellabona P. Bimodal CD40/Fas-Dependent Crosstalk between iNKT Cells and Tumor-Associated Macrophages Impairs Prostate Cancer Progression. Cell Rep. 2018 Mar 13;22(11):3006-3020. doi: 10.1016/j.celrep.2018.02.058. — View Citation
De Monte L, Reni M, Tassi E, Clavenna D, Papa I, Recalde H, Braga M, Di Carlo V, Doglioni C, Protti MP. Intratumor T helper type 2 cell infiltrate correlates with cancer-associated fibroblast thymic stromal lymphopoietin production and reduced survival in pancreatic cancer. J Exp Med. 2011 Mar 14;208(3):469-78. doi: 10.1084/jem.20101876. Epub 2011 Feb 21. — View Citation
Escobar G, Barbarossa L, Barbiera G, Norelli M, Genua M, Ranghetti A, Plati T, Camisa B, Brombin C, Cittaro D, Annoni A, Bondanza A, Ostuni R, Gentner B, Naldini L. Interferon gene therapy reprograms the leukemia microenvironment inducing protective immunity to multiple tumor antigens. Nat Commun. 2018 Jul 24;9(1):2896. doi: 10.1038/s41467-018-05315-0. — View Citation
Fruh M, Peters S. Genomic Features of Response to Combination Immunotherapy in Lung Cancer. Cancer Cell. 2018 May 14;33(5):791-793. doi: 10.1016/j.ccell.2018.04.005. — View Citation
Galluzzi L, Buque A, Kepp O, Zitvogel L, Kroemer G. Immunological Effects of Conventional Chemotherapy and Targeted Anticancer Agents. Cancer Cell. 2015 Dec 14;28(6):690-714. doi: 10.1016/j.ccell.2015.10.012. — View Citation
Galon J, Costes A, Sanchez-Cabo F, Kirilovsky A, Mlecnik B, Lagorce-Pages C, Tosolini M, Camus M, Berger A, Wind P, Zinzindohoue F, Bruneval P, Cugnenc PH, Trajanoski Z, Fridman WH, Pages F. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science. 2006 Sep 29;313(5795):1960-4. doi: 10.1126/science.1129139. — View Citation
Kitamura T, Qian BZ, Pollard JW. Immune cell promotion of metastasis. Nat Rev Immunol. 2015 Feb;15(2):73-86. doi: 10.1038/nri3789. — View Citation
Lambert AW, Pattabiraman DR, Weinberg RA. Emerging Biological Principles of Metastasis. Cell. 2017 Feb 9;168(4):670-691. doi: 10.1016/j.cell.2016.11.037. — View Citation
Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. doi: 10.1126/science.aan6733. Epub 2017 Jun 8. — View Citation
Lepore M, Mori L, De Libero G. The Conventional Nature of Non-MHC-Restricted T Cells. Front Immunol. 2018 Jun 14;9:1365. doi: 10.3389/fimmu.2018.01365. eCollection 2018. — View Citation
Lim WA, June CH. The Principles of Engineering Immune Cells to Treat Cancer. Cell. 2017 Feb 9;168(4):724-740. doi: 10.1016/j.cell.2017.01.016. — View Citation
Manici S, Sturniolo T, Imro MA, Hammer J, Sinigaglia F, Noppen C, Spagnoli G, Mazzi B, Bellone M, Dellabona P, Protti MP. Melanoma cells present a MAGE-3 epitope to CD4(+) cytotoxic T cells in association with histocompatibility leukocyte antigen DR11. J Exp Med. 1999 Mar 1;189(5):871-6. doi: 10.1084/jem.189.5.871. — View Citation
McGranahan N, Rosenthal R, Hiley CT, Rowan AJ, Watkins TBK, Wilson GA, Birkbak NJ, Veeriah S, Van Loo P, Herrero J, Swanton C; TRACERx Consortium. Allele-Specific HLA Loss and Immune Escape in Lung Cancer Evolution. Cell. 2017 Nov 30;171(6):1259-1271.e11. doi: 10.1016/j.cell.2017.10.001. Epub 2017 Oct 26. — View Citation
Medaglia C, Giladi A, Stoler-Barak L, De Giovanni M, Salame TM, Biram A, David E, Li H, Iannacone M, Shulman Z, Amit I. Spatial reconstruction of immune niches by combining photoactivatable reporters and scRNA-seq. Science. 2017 Dec 22;358(6370):1622-1626. doi: 10.1126/science.aao4277. Epub 2017 Dec 7. — View Citation
Mennonna D, Maccalli C, Romano MC, Garavaglia C, Capocefalo F, Bordoni R, Severgnini M, De Bellis G, Sidney J, Sette A, Gori A, Longhi R, Braga M, Ghirardelli L, Baldari L, Orsenigo E, Albarello L, Zino E, Fleischhauer K, Mazzola G, Ferrero N, Amoroso A, Casorati G, Parmiani G, Dellabona P. T cell neoepitope discovery in colorectal cancer by high throughput profiling of somatic mutations in expressed genes. Gut. 2017 Mar;66(3):454-463. doi: 10.1136/gutjnl-2015-309453. Epub 2015 Dec 17. — View Citation
Mlecnik B, Van den Eynde M, Bindea G, Church SE, Vasaturo A, Fredriksen T, Lafontaine L, Haicheur N, Marliot F, Debetancourt D, Pairet G, Jouret-Mourin A, Gigot JF, Hubert C, Danse E, Dragean C, Carrasco J, Humblet Y, Valge-Archer V, Berger A, Pages F, Machiels JP, Galon J. Comprehensive Intrametastatic Immune Quantification and Major Impact of Immunoscore on Survival. J Natl Cancer Inst. 2018 Jan 1;110(1). doi: 10.1093/jnci/djx123. Erratum In: J Natl Cancer Inst. 2018 Apr 1;110(4):438. — View Citation
Newman AM, Liu CL, Green MR, Gentles AJ, Feng W, Xu Y, Hoang CD, Diehn M, Alizadeh AA. Robust enumeration of cell subsets from tissue expression profiles. Nat Methods. 2015 May;12(5):453-7. doi: 10.1038/nmeth.3337. Epub 2015 Mar 30. — View Citation
Nordby T, Hugenschmidt H, Fagerland MW, Ikdahl T, Buanes T, Labori KJ. Follow-up after curative surgery for pancreatic ductal adenocarcinoma: asymptomatic recurrence is associated with improved survival. Eur J Surg Oncol. 2013 Jun;39(6):559-66. doi: 10.1016/j.ejso.2013.02.020. Epub 2013 Mar 14. — View Citation
Norelli M, Camisa B, Barbiera G, Falcone L, Purevdorj A, Genua M, Sanvito F, Ponzoni M, Doglioni C, Cristofori P, Traversari C, Bordignon C, Ciceri F, Ostuni R, Bonini C, Casucci M, Bondanza A. Monocyte-derived IL-1 and IL-6 are differentially required for cytokine-release syndrome and neurotoxicity due to CAR T cells. Nat Med. 2018 Jun;24(6):739-748. doi: 10.1038/s41591-018-0036-4. Epub 2018 May 28. — View Citation
Noviello M, Manfredi F, Ruggiero E, Perini T, Oliveira G, Cortesi F, De Simone P, Toffalori C, Gambacorta V, Greco R, Peccatori J, Casucci M, Casorati G, Dellabona P, Onozawa M, Teshima T, Griffioen M, Halkes CJM, Falkenburg JHF, Stolzel F, Altmann H, Bornhauser M, Waterhouse M, Zeiser R, Finke J, Cieri N, Bondanza A, Vago L, Ciceri F, Bonini C. Bone marrow central memory and memory stem T-cell exhaustion in AML patients relapsing after HSCT. Nat Commun. 2019 Mar 25;10(1):1065. doi: 10.1038/s41467-019-08871-1. — View Citation
Ruggiero E, Nicolay JP, Fronza R, Arens A, Paruzynski A, Nowrouzi A, Urenden G, Lulay C, Schneider S, Goerdt S, Glimm H, Krammer PH, Schmidt M, von Kalle C. High-resolution analysis of the human T-cell receptor repertoire. Nat Commun. 2015 Sep 1;6:8081. doi: 10.1038/ncomms9081. — View Citation
Schumacher TN, Schreiber RD. Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971. — View Citation
Tjaden C, Michalski CW, Strobel O, Giese N, Hennche AK, Buchler MW, Hackert T. Clinical Impact of Structured Follow-up After Pancreatic Surgery. Pancreas. 2016 Jul;45(6):895-9. doi: 10.1097/MPA.0000000000000564. — View Citation
Tran E, Ahmadzadeh M, Lu YC, Gros A, Turcotte S, Robbins PF, Gartner JJ, Zheng Z, Li YF, Ray S, Wunderlich JR, Somerville RP, Rosenberg SA. Immunogenicity of somatic mutations in human gastrointestinal cancers. Science. 2015 Dec 11;350(6266):1387-90. doi: 10.1126/science.aad1253. Epub 2015 Oct 29. — View Citation
Tran E, Robbins PF, Lu YC, Prickett TD, Gartner JJ, Jia L, Pasetto A, Zheng Z, Ray S, Groh EM, Kriley IR, Rosenberg SA. T-Cell Transfer Therapy Targeting Mutant KRAS in Cancer. N Engl J Med. 2016 Dec 8;375(23):2255-2262. doi: 10.1056/NEJMoa1609279. — View Citation
Tran E, Turcotte S, Gros A, Robbins PF, Lu YC, Dudley ME, Wunderlich JR, Somerville RP, Hogan K, Hinrichs CS, Parkhurst MR, Yang JC, Rosenberg SA. Cancer immunotherapy based on mutation-specific CD4+ T cells in a patient with epithelial cancer. Science. 2014 May 9;344(6184):641-5. doi: 10.1126/science.1251102. — View Citation
Tzeng CW, Fleming JB, Lee JE, Wang X, Pisters PW, Vauthey JN, Varadhachary G, Wolff RA, Katz MH. Yield of clinical and radiographic surveillance in patients with resected pancreatic adenocarcinoma following multimodal therapy. HPB (Oxford). 2012 Jun;14(6):365-72. doi: 10.1111/j.1477-2574.2012.00445.x. Epub 2012 Feb 28. — View Citation
Zheng C, Zheng L, Yoo JK, Guo H, Zhang Y, Guo X, Kang B, Hu R, Huang JY, Zhang Q, Liu Z, Dong M, Hu X, Ouyang W, Peng J, Zhang Z. Landscape of Infiltrating T Cells in Liver Cancer Revealed by Single-Cell Sequencing. Cell. 2017 Jun 15;169(7):1342-1356.e16. doi: 10.1016/j.cell.2017.05.035. — View Citation
Zitvogel L, Galluzzi L, Smyth MJ, Kroemer G. Mechanism of action of conventional and targeted anticancer therapies: reinstating immunosurveillance. Immunity. 2013 Jul 25;39(1):74-88. doi: 10.1016/j.immuni.2013.06.014. — View Citation
* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Definition of tumor mutational burden, epigenetic and gene expression profile of the CRC and PDAC metastatic liver at bulk and at single cell level | CRC/PDAC MTS samples will be analyzed by:
Whole exome DNA sequencing RNA sequencing ATAC sequencing Single cell RNA sequencing on sorted myelomonocytic and T cells infiltrating CRC/PDAC MTS samples. Naive vs chemotherapy treated lesions as well as primary vs MTS lesions will be compared to evaluate chemotherapy-induced modifications and the molecular evolution in the distinct tumor sites, respectively. |
After liver metastasis/primary tumor resection/biopsy, usually within 12 months | |
Primary | Characterization of the immune landscapes of CRC and, if possible, PDAC liver MTS by high dimensional flow cytometry | Single cell suspension of CRC and PDAC MTS and paired autologous PBMCs and portal blood harvested before and after pre-operatory chemotherapy, will be analyzed by a series of parallel polychromatic high dimensional 28 color flow cytometry panels to study:
Conventional MHC-restricted Tab cells, the main anti-tumor effectors; Innate-like T cells; B cells; Myelomonocytic populations involved in the stimulation or suppression of anti-tumor responses. Whenever available, matched primary vs MTS lesions will be compared to evaluate the immune landscapes in the distinct tumor sites. |
For tissue specimens: immediately after tumor tissue resection/biopsy (analyses on fresh samples); for blood specimens: after blood drawing, usually within 12 months (analyses on fresh and/or thawed samples) | |
Primary | Histological validation of the molecular results obtained in 1. and 2. | Validation of relevant markers and molecular pathways in terms of anatomical distribution, performed by polychromatic immunofluorence (IF, up to 6 colors) and immunohistochemistry (IHC, up to 4 colors) stainings on MTS CRC and PDAC biopsies, perilesional parenchyma and, whenever available, matched primary tumor samples. In addition to multiplex IF and IHC, some specimens will be characterized more deeply with advanced spatial proteomics technologies, such as GeoMx Digital Spatial Profiler (Nanostring). | After liver metastasis/primary tumor resection/biopsy, usually within 12 months | |
Primary | Definition of the antigenic landscape and TCR repertoire of CRC and PDAC liver MTS | Identification of tumor-reactive TCRs will be pursued through different and complementary strategies:
The most relevant inhibitory checkpoint genes/pathways expressed by MTS-TILs will be used to enrich for tumor specificities by cell sorting harvested from CRC/PDAC MTS tumors, portal, hepatic and peripheral blood sample. After their activation, responding T cell cultures will be subject to bulk and single-cell TCR seq; In samples characterized by a low percentage of MTS-TILs, single cell immune profiling will be performed in order to simultaneously determine gene expression and correctly pair chain TCR sequences from individual T cells; The library of tumor-specific TCRs identified will be transiently expressed in reporter Jurkat cells to confirm their tumor antigen specificity; Identification and functional validation of transmembrane molecules enriched in cancer cells as possible targets for CAR design. |
After liver metastasis/primary tumor resection/biopsy, usually within 12 months | |
Secondary | Evaluation of the molecular and cellular composition of CRC and, if possible, PDAC liver MTS by spatial transcriptomics technologies (NICHE-seq and Visium) | Application of NICHE-seq to freshly isolated human tissues using photoactivatable (cages) fluorophores able to permeate within the cells, in particular comparing =5 chemotherapy treated vs =5 naive CRC MTS samples and =3 PDAC MTS samples in order elucidate the high-order spatial organization of immune cell types in the NICHE-seq area and their molecular pathways, at the same time. NICHE-seq and conventional single-cell RNA seq will proceed side-by-side to compare results. Some selected specimens will be analyzed with more advanced spatial transcriptomics techniques developed in recent years, like Visium Spatial Gene Expression (10X Genomics). | After liver metastasis/primary tumor resection/biopsy, usually within 12 months | |
Secondary | Collection of clinical follow-up data | Overall survival (OS), disease free survival (DFS) and other follow-up parameters (patient's status, CEA levels, Ca 19-9 levels, adjuvant chemotherapy after surgery, date and site of recurrence, treatment at recurrence) will be collected and possibly correlated with the markers and pathways identified and validated in primary outcome measures. | CRC patients: throughout the postoperative follow-up, for a maximum of 36 months; PDAC patients: throughout the postoperative follow-up, for a maximum of 24 months | |
Secondary | Collection and biobanking of follow-up samples from patients with CRC and metachronous PDAC MTS to the liver | CRC MTS patients: part of peripheral blood collected for hematochemical testing during follow-up visits
newly-diagnosed metachronous PDAC MTS patients, previously enrolled in the non-metastatic PDAC cohort: peripheral blood and, whenever possible, tumor tissue from liver metastasis (fine-needle bioptic sample) collected at the time of liver recurrence diagnosis, during the follow-up after the primary tumor surgery. |
CRC: during the postoperative follow-up (up to 36 months), at six-month intervals; PDAC: during the postoperative follow-up (up to 24-months), at time of liver recurrence | |
Secondary | Biobanking of biospecimens collected from CRC and PDAC patients and from healthy donors | blood samples as detailed in the "biospecimen description" section: cryopreservation in liquid nitrogen of whole blood, plasma and purified mononuclear cells.
tissue samples as detailed in the "biospecimen description" section: i) formalin-fixation and paraffin embedding; ii) OCT-based embedding and cryopreservation in liquid nitrogen. Biobanked samples will be studied as described in 1-5, but possibly also with new state-of-the-art technologies developed in the next future. Moreover, they will be used to set up in vitro and in vivo systems (e.g., patient-derived organoids, tissue chips, possibly patient-derived xenograft models) to validate the efficacy and safety of the novel ATMPs developed by research program. |
Throughout the protocol (7 years) |
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