Viewing Study NCT03299452



Ignite Creation Date: 2024-05-06 @ 10:34 AM
Last Modification Date: 2024-10-26 @ 12:32 PM
Study NCT ID: NCT03299452
Status: UNKNOWN
Last Update Posted: 2019-02-15
First Post: 2017-08-28

Brief Title: Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor
Sponsor: Haining Health-Coming Biotech Co Ltd
Organization: Haining Health-Coming Biotech Co Ltd

Study Overview

Official Title: Clinical Studies by Using Alphacait to Screen Drug Combinations for Advanced Solid Tumor
Status: UNKNOWN
Status Verified Date: 2019-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a single-center open-label single-arm non-randomized study designed to evaluate PFS safety overall survival OS objective response rate OPR disease control rate DCR and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor
Detailed Description: Tumor heterogeneity leads to a significant difference in the rate of response to drugs in patients with the same pathological type According to the information the current initial effective rate of domestic and foreign chemotherapeutic single drug is no more than 30 even if treated with repeated medication or replacement treatment program the responsive rate is generally not more than 10 This heterogeneity of tumor is the biological basis of precision medicine and how to predict cancer drug sensitivity is a clinical need to solve the practical problems

Traditional PDX patient-derived engraft technology utilizes patients fresh tumor tissue containing tumor cells stromal cells and vascular components and inoculates in immunodeficient mice to establish mouse tumor model This method can better reflect the true biological characteristics of tumor while the mouse tumor tissue can be continuously passed on and greatly facilitate tumor biology research According to the transplant site it can be divided into orthotopic transplantation and ectopic transplantation mostly subcutaneous or renal transplantation However the traditional PDX model has its disadvantage of low success rate and time consuming Most of the tumor matrix after transplantation can be replaced by the corresponding components in mice leading to differences in the biological properties of the original tumor

In view of this imperfection we developed an optimized drug selection model based on the Alphacait screening system that combines artificial intelligence synthetic lethal and combinational chemistry which allows rapid selection of candidates from millions of drug combinations We want to provide physicians with individualized drug therapy through a new in vitro and in vivo drug-sensitive screening technique to achieve rapid and accurate selection of cancer clinical treatment

In order to achieve the two key requirements of tumor tissue culture system in vitro the establishment of tumor microenvironment we introduced the millimeter-sized microbeads based on combinatorial chemistry in the culture medium The surface of the microbeads is coated with small molecules that can specifically absorb high levels of metabolites secreted by the tumor cells into the matrix thereby mimicking in vivo circumstances In short we innovatively applied microbeads technology to solve the inherent limitations of 3D organoid culture - no blood circulation in vitro

Purpose and design Primary endpoint progression-free survival PFS Secondary endpoints overall survival OS disease control rate DCR objective response rate ORR safety blood test and gene test in the aspect of biomarkers Expectations of exploratory markers for this study include the status of exploratory biomarkers associated with immunohistochemistry IHC or quantitative reverse transcription polymerase chain reaction qRT-PCR a new generation sequencing method NGS Nanostring technique and or other methods to evaluate archived andor newly acquired tumor tissue as well as its association with disease status andor Including but not limited to somatic mutations and other exploratory markers according to qRT-PCR and NGS techniques and to evaluate the relationship between the therapeutic response the status of the biomarker during exploratory treatment and during treatment and the evaluation of plasma serum or whole blood samples including but not limited to somatic mutations and other exploratory markers The association of the above markers with disease status and or therapeutic response

Research design This is a single-center open-label single-arm non-randomized study designed to evaluate PFS safety overall survival OS objective response rate OPR disease control rate DCR and biomarkers of cancer therapy based on the Alphacait screening system in subjects with advanced malignant tumor

List of drugs used by the Alphacait screening system is as follow

Non chemotherapy drug

Albendazole Tablets Alfacalcidol Soft Capsules Aripiprazole Tablets Anastrozole Tablets Azithromycin Acyclovir Dispersible Tablets Aztreonam OLanzapine Tablets Omeprazole Enteric-coated Capsules Ornidazole and Sodium Chloride Injection resveratrol citicoline sodium injection BevacizumabAvastin Phenobarbital Amlodipine Besylate Tablets phenytoin sodium tablet Piroxicam tablets Allopurinol tablets Propylthiouracil Tablets Sodium Valproate for Injection Nuprin Tablets Goserelin Acetate Sustained-Release Depot Zoladex Megestrol Acetate Dispersible Tablets Prednisone Acetate Tablets Desmopressin Acetate Injection Low-molecular-weight Heparin Sodium Injection Digoxin Tablets Dexamethasone Sodium phosphate Injection Bacillus Licheniformis Capsule tabellae paracetamol Levodopa and Benserazide Hydrochloride Tablets Domperidone Tablets Metformin Famotidine tablets Fenbendazole Nitrofurantoin Enteric-coated Tablets Fluconazole and Sodium Chloride Injection Haloperidol Injection Flupentixol and Melitracen Tablets Compound Zedoary Turmeric Oil Suppositories Compound Sulfamethoxazole Injection Compound Hypotensive Tablets Bisoprolol Fumarate Tablets Quetiapine Fumarate Tablets Injection Mannitou Heparin sodium Bismuth Potassium Citrate Tablets Banan tablet Erythromycin enteric capsules Metoprolol succinate sustained-release tablets Warevan tablet Huaier granule Cyclosporine Progesterone injection Gabapentin capsules Mebendazole Chewable Tablets Apatinib Mesylate Phentolamine Mesylate Injection Imatinib Mesylate Neostigmine Methylsulfate Injection Imatinib Mesylate Tablets Thiamazole Tablets Metronidazole Colloidal Bismuth Pectin Capsules Metoprolol Tartrate Tablets Carbamazepine Tablets Captopril Tablets Clarithromycin Sustained-release Tablets Clindamycin Phosphate Injection Lamictal Letrozole Tablets Lara chips Tripterygium Glycosides Atorvastatin Ribavirin injection Rifampicin Capsules Risperidone Tablets Primaquine Diphosphate Chloroquine Phosphate Tablets Amikacin Sulfate Injection Atropine sulphate injection Magnesium sulfate injection Azathioprine Tablets Sulfasalazine Enteric-coated Tablets Roxithromycin Soft Capsules Clozapine Tablets Desloratadine Tablets Flupirtine Maleate Fluvoxamine Maleate Tablets Chlorphenamine Maleate Tablets Enalapril Maleate Tablets Meloxicam Mesalazine Enteric-coated Tablets Mirtazapine Naproxen Tablets Nikethamide Injection Nimodipine Injection Nitrendipine Tablets Norfloxacin Capsules Hydroxycarbamide Tablets Artemisinin Benzylpenicillin sodium Hydrocortisone Injection Citalopram Hydrobromide Tablets Gentamicin Colchicine Tablets Doxifluridine Capsules Deslanoside Injection Ciprofloxacin Lactate and Sodium Chloride Injection Celecoxib Capsules Trifluoperazine Tetrastigma hemsleyanum Diels et Gilg Thalidomide Tablets Sulpiride Tablets Diclofenac Potassium Capsules Clostridium butyricum TO-A Dihydroartemisinin and Piperaquine Phosphate Tablets Tetracycline Tablets Lithium Carbonate Sustained-release Tablets Tegafur Injection Teicoplanin Tinidazole and Sodium Chloride Injection Cefoxitin Ceftizoxime Sodium Topiramate Tablets Vancomycin Tretinoin Tablets Vemurafenib Vitamin A Vitamin B2 Tablets Vitamin D2 Injection Cimetidine Tablets Cimetidine Injection Nifedipine Sustained Release Tablets Nitroglycerin Injection Isosorbide Dinitrate Injection Valsartan Dispersible Tablets Simvastatin Tablets Thymalfasin Ursodeoxycholic Acid Folic acid calcium salt hydrate Amitriptyline Hydrochloride Tablets Bupropion Hydrochloride Sustained-Release Tablets Amiodarone Hydrochloride Tablets Ondansetron Hydrochloride Injection Betahistine Hydrochloride Injection Diphenhydramine Hydrochloride Injection Bupropion Hydrochloride Injection Tablets 3-Hydroxytyramine hydrochloride Doxepin Hydrochloride Flunayizine Hydrochloride Capsules Prozac Metoclopramide Dihydrochloride Injection Arginine Hydrochloride Injection Clindamycin Hydrochloride Injection Raloxifene Hydrochloride Tablets Ranitidine Hydrochloride Capsules Lidocaine Hydrochloride Injection Lobeline Hydrochloride Injection Chlorpromazine Clomipramine Hydrochloride Tablets Omeprazole Magnesium Enteric-coated Tablets Mexiletine Hydrochloride Tablets Paroxetine Hydrochloride Tablets Procaine Hydrochloride for Injection Trazodone Hydrochloride Tablets Daunorubicin hydrochloride Cyproheptadine Hydrochloride Tablets Sertraline Hydrochloride Tablets Tamsulosin Hydrochloride Sustained Release Capsules Terazosin Hydrochloride Tablets Verapamil Hydrochloride Tablets Venlafaxine Hydrochloride Capsules Raceanisodamine Hydrochloride Injection Berberine Hydrochloride Tablets Ethambutol Hydrochloride Tablets Levofloxacin Hydrochloride for Injection Itraconazole Ivermectin IPTGIsopropyl-β-D-thiogalactoside Isopropyl-beta-D-thiogalactopyranoside Isoniazid Tablets Indapamide Tablets Indomethacin Enteric-coated Tablets Amoxicillin Sodium and Clavulanate Potassium for injection Azithromycin for Injection Acyclovir for Injection Ampicillin Sodium Injection Omeprazole Sodium for Injection Oxacillin Sodium for Injection Biapenem for Injection Benzathine Penicillin For Injection Sodium Valproate for Injection Ganciclovir Fosfomycin Sodium for Injection Asparaginase Urokinase for Injection Piperacillin Sodium for Injection Artesunate for Injection Sodium Nitroprusside Diltiazem Hydrochloride for Injection Recombinant Human Interferon gamma for Injection Levobupivacaine Levothyroxine Sodium Tablets Levofloxacin Tablets

Chemotherapy and target therapy drugs

Aidi injection Oxaliplatin for Injection Epirubicin Dacarbazine Dabrafenib mesylate Dabratinib Dasatinib Tablets Sorafenib Tosylate Tablets Doxorubicin Docetaxel 5-Fluorouracil Juyuansuan Tamoxifen Cino bufotalin Cyclophosphamide Gefitinib pure powder Gemcitabine hydrochloride Methotrexate Carboplatin Capecitabine Kanglaite Injection Raltitrexed Mabthera Lobaplatin for Injection Mitoxantrone Nedaplatin Mercaptopurine Cisplatin Mitomycin for Injection Tacrolimus Tegafur Gimeracil and Oteracil Potassium Temozolomide Cetuximab Solution for Infusion Lobaplatin for Injection Mitoxantrone Nedaplatin Mercaptopurine Cisplatin Mitomycin for Injection Tacrolimus Tegafur Gimeracil and Oteracil Potassium Temozolomide Cetuximab Solution for Infusion

Chinese Herb Medicine

English Name Latin Name Jobs tears seed Coicis Semen Japanese Ardisia Herb Japanese Ardisia Herb White Hyacinth Bean Semen Dolichoris Album Spreading Hedyotis Herb Hedyotis diffusa Willowleaf Swallowwort Rhizome Rhizoma Cynanchi Stauntonii Large head Atractylodes Rh Rhizoma Atractylodis Macrocephalae Sessile Stemona Root Japanese Stemona Root Lily Lilium brownii var viridulum Seman Platycladi Seman Isatis root Isatis tinctoria Herba Lobeliae Chinensis Lobelia chinensis Lour Pinellia ternata Pinellia ternata Thunb Breit Scutellaria barbata Scutellaria barbata CoasiaI GIehnia Root Glehnia littoralis Fritillary fritillary Ficus pumila Linn Ficus pumila Seed-coat of Hyacinth Dolichos Areca Seed Betel Nut Semen Arecae Malaytea Scurfpea Fruit Fructus Psoraleae Semen raphani Silkworm shit Faeces Bombycis Siberian Cocklour Fruit Fructus Xanthii Rhizome of Swordlike Atractylodes Rhizoma Atractylodis Root of Chinese Thorowax Radix Bupleuri Radices paeoniae rubra Paeoniae Rubra Radix Dan - shen Root Salviae Miltiorrhizae Radix Tree Peony Root - bark Moutan Radicis Cortex Chinese Goldthread Rhizome Coptidis Rhizoma Skunk Bugbane Rhizome Cimicifugae Foetidae Rhizoma Coix seed Semen Coicis Szechwan Chinaberry Fruit Fructus Meliae Toosendan Radix Cyathulate Radix Cyathulae Common Andrographis Herb Herba Andrographis Radix et Caulis Acanthopanacis Senticosi Radix et Caulis Acanthopanacis Senticosi Japanese Thistle Herbor Root Herba seu Radix Cirsii Japonici Indigowoad Leaf Leaf of Indigowoad Folium Isatidis Danshen Root Root of Dan-shen Salviae Miltiorrhizae Radix et Rhizoma Root of Pilose Asiabell Radix Codonopsis Fructus Oryzae Germinatus Fructus Oryzae Germinatus Humifuse Euphorbia Herb Herba Euphorbiae Humifusae Chinese Waxgourd Peel Exocarpium Benincasae Waxgourd seed Semen Benincasae Rabdosia rubesenshamst Rabdosia rubescens Rhioxma Curcumae Aeruginosae Rhizoma Curcumae Divaricate Saposhnikovia RootRadix Saposhnikoviae Indian Buead Poria Pine among the Indian Bread Blighted Wheat Fructus Tritici Levis Radix Glycyrrhizae Radix Glycyrrhizae Toad skin Perfoliate Knotweed Herb Polygonum perfoliatum Ligusticum sinense Oliv Rhizoma Ligustici Barbary Wolfberry Fruit Fructus Lycii Herba Pogostemonis Herba Pogostemonis Sargassum Sargassum Yerbadetajo Herb Herba Ecliptae Eclipta prostrala Terminalia chebula Retz Taxus chinensis Taxus chinensis Pilger Rehd Flos Carthami Flos Carthami Root of Kirilow Rhodiola Herba Rhodiolae Figwortflower Picrorhiza Rhizome Rhizoma Picrorhizae Polygonum cuspidatum Rhizoma Polygoni Cuspidati Pricklyash Peel Pericarpium Zanthoxyli Talcum Talcum Exocarpium Citri Grandis Exocarpium Citri Grandis Phellodendron Chinese Schneid Cortex Phellodendri Manyflower Solomonseal Rhizome Rhizoma Polygonati Radix Astragali Radix Astragali seu Hedysari Radix Scutellariae Flos Celosiae Cristae Flos Celosiae Cristatae Suberect Spatholobus Stem Caulis Spatholobi Rhizoma Curcumae Longae Rhizoma Curcumae Longae Christina Loosestrife HerbHerba Lysimachiae Japanese Honysuckle Flower Bud Flos Lonicerae Cherokee Rose Fruit Fructus Rosae Laevigatae Chrysanthemum flower Flos Chrysanthemi Spikemoss Herba Selaginellae Cassia seed Semen Cassiae Lightyellow sophora root Radix Sophorae Flavescentis Kelp Laminariae Thallus Semen Litchi Semen Litchi Chinese trumpet creeper Campsis grandiflora Diverse Wormwood Herb Herba Artemisiae Anomalae Radix Gentianae Gentiana Scabra Bunge Reed Rhizome Stemmacanthae Unifori Radix Caulis Trachelospermi Trachelospermi Jasminoidis Caulis Lv Bean Spermodermis Phaseoli Radiati European Verbena Herb Herba Verbenae Officinalis Herba Portulacae Portulaca oleracea L Radix Ophiopogonis Ophiopogonis Radix Fructus Hordei Germinatus Hordei Germinatus Fructus Concha Ostreae Concha Ostreae Costustoot Common Vladimiria Root Aucklandiae Radix Fructus Ligustri Lucidi Ligustri Lucidi Fructus Fortune Eupatorium Herb Eupatorii Fortunei Herba Folium Eriobotryae Eriobotryae Japonicae Folium Dandelion Herba Taraxaci Flower of Shepherdspurse Capsella bursa-pastoris LMedic Rhizoma Homalomenae Rhizoma Homalomenae Gordon Enryale Seed Euryales Semen Radix Gentinae Gentianae Macrophyllae Radix Cortex Fraxini Fraxini Cortex Caulis SinomeniiI Caulis Sinomenii Semen Celosiae Celosiae Argenteae Semen Herba Dianthi Dianthi Superbi Herba Caulis Lonicerae Lonicerae Caulis Cortex CinnamoniCinnamomi Cassiae Cortex Rhizoma Srarganii Rhizoma Sparganii Sanchi Panax pseudo-ginseng var Radix tetrastigme Tetrastigma hemsleyanum Diels et Gilg Folium Mori Mori Folium Chinese yam Dioscorea opposite Amorphophallus rivieri Durieu Amorphophallus rivieri Durieu Snake venom Snake Slough Serpentis Periostracum Rhizoma Belamcandae rhizoma belamcandae Largetrifoliolious Bugbane RhizmomeRhizoma Cimicifugae Radix Sanguisorbae SanguisorbaofficinalisL Eucommia ulmoides Oliver Eucommia ulmoides Rhizoma Zingiberis RecensZingiber officinale Roscoe Salvia chinensis Benth Salvia chinensis Benth Folium Photiniae Photinia serrulata Lindl Lignum Sappan Lignum Sappan Semen Persicae Semen Persicae Radix Asparagi Radix Asparagi Root of Nakedcaule Groundsel Radix Semiaquilegiae Root of Common carpesium Herba Carpesii Abrotanoidis Semen lepidii Semen Lepidii Herb of Tuberculate Speranskia Phryma leptostachya L subsp asiatica Hara China Dodder Semen Cuscutae Semen Vaccariae Semen Vaccariae Herb of Coffee Senna Cassia occidentalis Linn Fructus Mume Fructus Mume Root of Combined Spicebush Radix Linderae Fig Ficus carica Linn Medicinal Evodia Fruit Evodia rutaecarpa Juss Benth Chinese Gall Chinese Nut-gall Rhus chinensis Mill Sessileflower Acanthopanax Bark Cortex Acanthopanax Radicis All-grass of Bluecalyx Japanese Rabdosia Fructus Foeniculi Fructus Foeniculi Common Cephalanoplos Herb Cirsium setosum Willd MB Flos Magnoliae Flos Magnoliae Paniculate Swallowwort Root Cynanchum paniculatum Bunge Kitagawa Linseedseed of Flax Linseed seed of Flax Fructus Alpiniae Oxyphyllae Alpinia oxyphylla Miq Jobs tears seed Semen Coicis Herba Artemisiae Scopariae ArtemisiacapillarisThunb Folium Ginkgo Ginkgobiloba Heartleaf Houttuymia Herb Houttuynia cordata Thunb Turmeric Root-tuber Radix Curcumae Akebia Fruit Foreknowledge Hiraute Shiny Bugleweek Herb Aconitum gymnandrum Maxim Rhizoma Paridis RhizomaParidis Polyporus Polyporus Root of Sinkiang Arnebia Lithospermum erythrorhizon Sieb et Zucc Herba Violae Viola yedoensis Makino Fluoritum Fluoritum Caulis Perillae Perilla frutescens LBritton

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None