Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Urinary Bladder Neoplasms

Genomic Instability

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in VESPER cohort

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in Saint-Louis cohort

Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine included in COBLAnCE cohort

Blood from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine

neoadjuvant chemotherapy with cisplatine

Yves ALLORY, MD

This study will allow the investigators to better assess the efficiency of neoadjuvant chemotherapy before cystectomy by training a predictive model on different patient cohorts with bladder cancer.

The project is based on three prospective cohorts of patients with MIBC: the VESPER trial (n=296), the St-Louis Hospital cohort (n=99), and the COBLAnCE cohort (n=312). Using WES and RNAseq, the investigators will determine genomic instability, DDR gene mutation and molecular subtypes. After digitization of tumour slides, the investigators will train and test predictive models based on deep learning approaches to predict outcome after neoadjuvant chemotherapy, either by estimating molecular subtypes and genetic features from pathological images, or by directly defining a prognostic signature. The statistical analyses will assess the performance of the models combining genomic instability, DNA Damage Response mutations and/or molecular subtyping to predict outcome after neoadjuvant chemotherapy and compare them with the models based on WSI deep learning approaches. These results will help to design new therapeutic strategies.

Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy

Survival prEdiction in bLadder Cancer Patients Treated by nEoadjuvant Chemotherapy Before cysTectomy

The time from enrollment to progression or death

Institut Curie

University Hospital, Rouen

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Antibodies

Capecitabine

Paclitaxel

Bevacizumab

Everolimus

Albumin-Bound Paclitaxel

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

If patients were LAR subtype with HER2 gene activated mutation

If patients were LAR subtype without HER2 gene activated mutation, but had PI3K/AKT/mTOR pathway mutation

If patients were IM subtype (CD8 positive T cell more than 10%)

If patients were BLIS subtype or MES subtype without PI3K/AKT/mTOR pathway activation

If patients were MES subtype and had PI3K/AKT/mTOR pathway activation

A1: pyrotinib(EGFR-TKI) 400mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

A1: Pyrotinib with nab-paclitaxel

A2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

A2: nab-paclitaxel

B1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

B1: everolimus with nab-paclitaxel

B2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

B2: nab-paclitaxel

C1: PD-1 antibody SHR1210 200mg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt + famitinib 20mg po qd, 4 weeks as a cycle

C1: PD-1 with nab-paclitaxel and famitinib

C2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

C2: nab-paclitaxel

D1: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks.

D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine

D2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks.

D2: nab-paclitaxel, with maintenance of capecitabine

E1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

E1: everolimus with nab-paclitaxel

E2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

E2: nab-paclitaxel

This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.

This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment vs. traditional chemotherapy in patients with unresectable locally advanced or metastatic triple negative breast cancer. The specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype staining.These tests would be done on their rebiopsy tumor specimen. Specifically, as to TNBC molecular subtyping,FUSCC data identified the genomic aberrations that drive each TNBC subtype by applying an integrative analysis combining somatic mutation, copy number aberrations (CNAs) and gene expression profiles, which classified TNBC patients into four subtypes, namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune suppressed (BLIS), and mesenchymal-like (MES). Then, FUSCC conducted a IHC subtyping model to replace complex genomic sequencing, which have been validated in FUSCC cohort.FUSCC 500+ gene panel was developed combining public database(TCGA, METABRIC, 560WES, MSKCC-IMPACT ect.) and FUSCC private TNBC database.

An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.

An Umbrella Trial Based on Molecular Pathway for Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer (FUTURE SUPER)

Refers to the time between the patient's enrollment and any recorded tumor progression or death from any cause.

Refers to the period from the date of the first study dose to the date of death for any reason.

Defined as the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of CR and PR.

Defined as the date from the first recording of tumor response (assessed according to RECIST 1.1) to the first recording of the objective progression of the tumor (assessed according to RECIST 1.1) or to the date of death for any reason, whichever occurs first.

The proportion of subjects who received treatment and whose best overall response (BOR) was assessed as complete response (CR), partial response (PR) and stable disease (SD) ≥4 weeks according to RECIST1.1.

AE refers to any untoward medical occurrence in a study subject administered an investigational product which does not necessarily have a causal relationship with the treatment. AE is assessed according to the NCI-CTC AE 5.0.

Fudan University

Director of General Surgery of Fudan Shanghai Cancer Center

If patients were triple-negative breast cancer with IM subtype and HER2-low-positive

If patients were triple-negative breast cancer with IM subtype and HER2-zero

If patients were triple-negative breast cancer with BLIS subtype and HER2-low-positive

If patients were triple-negative breast cancer with BLIS subtype and HER2-zero

If patients were triple-negative breast cancer with LAR subtype and HER2-low-positive

If patients were triple-negative breast cancer with LAR subtype and HER2-zero

If patients were triple-negative breast cancer with MES subtype and HER2-low-positive

If patients were triple-negative breast cancer with MES subtype and HER2-zero

A1: an anti-HER2 antibody-drug conjugate (ADC)

A1: SHR-A1811

A2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)

Camrelizumab: an anti-programmed death-1 (PD-1) antibody

A2: SHR-A1811 with Camrelizumab

B1: an Trophoblast cell-surface antigen 2 (TROP2) ADC

B1: TROP2 ADC

B2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC

Camrelizumab: an anti-programmed death-1 (PD-1) antibody

B2: TROP2 ADC with Camrelizumab

C1: an anti-HER2 antibody-drug conjugate (ADC)

C1: SHR-A1811

C2: SHR-A1811: an anti-HER2 antibody-drug conjugate (ADC)

BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)

C2: SHR-A1811 with BP102

D1: an Trophoblast cell-surface antigen 2 (TROP2) ADC

D1: TROP2 ADC

D2: TROP2 ADC : an Trophoblast cell-surface antigen 2 (TROP2) ADC

BP102: a humanized recombinant monoclonal IgG1 antibody (biosimilar to bevacizumab)

D2: TROP2 ADC with BP102

E1: an anti-HER2 antibody-drug conjugate (ADC)

E1: SHR-A1811

F1: an Trophoblast cell-surface antigen 2 (TROP2) ADC

F1: TROP2 ADC

G1: an anti-HER2 antibody-drug conjugate (ADC)

G1: SHR-A1811

H1: an Trophoblast cell-surface antigen 2 (TROP2) ADC

H1: TROP2 ADC

Zhimin Shao, M.D.

Yin Liu, M.D.

This is a Phase II, open-label, Single-center platform study research based on molecular subtypes to explore precision therapy in refractory triple-negative breast cancer.

This is a Phase II, open-label, Single-center platform study，Based on FUSCC four TNBC subtypes and the results of the previous FUTURE trial, the investigators designed this platform trial, which for combined the TNBC subtyping and genomic sequencing-guided precision targeted therapy for refractory metastatic TNBC patients. In this trial, refractory mTNBC patients eligible for inclusion can be divided into various precision treatment group according to molecular typing and subtyping to evaluate the efficacy and safety of multiple precision targeted treatment. The research therapy arm can be updated with the update of basic translational research in our center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs.

FUSCC Refractory TNBC Platform Study (FUTURE2.0)

Precision Platform Study of Refractory Triple-negative Breast Cancer Based on Molecular Subtyping（(A Phase II, Open-label, Single-center Platform Study）

The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)

Time to progressive disease (according to RECIST1.1)

Duration of whose best outcome is complete remission or partial remission (according to RECIST1.1)

The proportion of patients with the best overall response of CR, PR, or stable disease (SD)

To evaluate the rate of adverse effects of patient by the standard CTCAE scale (V5.0)

Professor

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Perform the diagnosis of Raman analyzer and immunohistochemistry or genetic test on the same sample.

Perform two diagnostic methods on the same sample

Immunohistochemistry or genetic test

Wang Yinyan, MD and PhD

Yinyan Wang, MD and PhD

Qing Mao

Dongming Yan

Shouwei Li

To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples.

1500 samples were included retrospectively with the spectra data obtained from Raman analyzer to establish clinical intelligence model, modifying the analyzer. Based on statistical calculations, 200 glioma samples will be included in the trial in all trial centers prospectively. Compare the results between the Raman analyzer and Immunohistochemistry or genetic test results. And calculate the AUC, the accuracy, sensitivity, the specificity, and other indicators of Raman analyzer.

During surgery, core tissue samples were taken from subjects. The test samples size:0.2cm\<length diameter ≤ 2cm. The sample testing result is based on the Raman test points. Then take the same tissue sample for Immunohistochemistry or genetic test.

Statistical description of all data, including baseline data, all efficacy indicators, and all safety data. The measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; Provide frequency and composition ratio for counting data. The baseline data was analyzed using the Full Analysis Set (FAS); The effectiveness analysis adopts FAS and PPS; The security analysis uses the Security Dataset (SS).

The same sample was diagnosed using Raman spectroscopy and immunohistochemistry or genetic test, respectively. Calculate the AUC, the accuracy, the sensitivity and specificity of a Raman analyzer using immunohistochemistry or genetic test results as the gold standard.

Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting immunohistochemistry or genetic test after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer.

Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery

Evaluate the Effectiveness and Safety of the Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery, Using Samples From Brain Resection Tissue (Ambispective, Multicenter, Blind Evaluation, Single Group Target Value Method)

The Area Under the Curve of the ROC curve illustrates the performance of Raman analyzer for the diagnosis of molecular subtype in glioma, confirmed by immunohistochemistry or genetic test.

The proportion of tissue samples with consistent results between Raman analyzer detection and immunohistochemistry or genetic test.

Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the same molecular subtype.

Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the different molecular subtype.

Kappa coefficient≥0.75 indicates high consistency; 0.75\>Kappa coefficient≥0.4, considered consistent; If the Kappa coefficient is less than 0.4, it is considered inconsistent.

Time required from emitting laser to completing single point detection

Number of subjects with AE/total number of subjects ×100%

Number of subjects with SAE/total number of subjects ×100%

Possible damage to device operators during the use and maintenance of the Raman analyzers

West China Hospital

The First Affiliated Hospital of Zhengzhou University

Capital Medical University

Jiangsu Raman Medical Equipment Co., Ltd.

Beijing Tiantan Hospital

Nootropic Agents

Gastrointestinal Agents

Lipid Regulating Agents

Anti-Allergic Agents

Anti-Inflammatory Agents

Respiratory System Agents

Vitamins

Immunomodulating Agents

Choline

Efavirenz

Cromolyn Sodium

Reverse Transcriptase Inhibitors

Antiviral Agents

Cytochrome P-450 Enzyme Inhibitors

Hypolipidemic Agents

Anti-Asthmatic Agents

Sodium cromoglicate with anti-PD-1 immunotherapy

PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)

anti-PD-1 antibody and chemotherapy

Sodium Cromoglicate will be administered intranasally (nasal spray) (5 spray each nostril 4 times a day, 1 mg/spray)

Sodium Cromoglicate

Zhimin Shao, Professor

Zhonghua Wang, Professor

Yin Liu, Doctor

This is a Phase II, open-label, three-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, or efavirenz) with immune checkpoint inhibitor in mTNBC (triple negative breast cancer) patients who progressed during previous immune checkpoint inhibitors.

This is a Phase II, open-label, three-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, or efavirenz) with immune checkpoint inhibitors in metastatic TNBC (triple negative breast cancer) patients who progressed during or following previous immune checkpoint inhibitors. The investigators have achieved a breakthrough in the FUTURE study with an ORR (objective response rate) reaching 52.6% in IM (immunomodulatory) subtype TNBC patients. Despite this, there are still some IM subtype patients resistant to immunotherapy. How to reverse immunotherapy resistance or how to increase the sensitivity of immunotherapy efficacy, has become an urgent clinical problem to be solved. The preclinical results of our center show that TMAO, choline, and efavirenz play a potentially important role in regulating the tumor immune microenvironment. Oral choline can improve TMAO content in mouse serum, play the role of activating anti-tumor immunity, and improve immunotherapy efficacy. Preclinical studies of our center also show that sodium cromoglicate can enhance the anti-tumor immune response by inhibiting the activation of mast cells, increase the infiltration and function of cytotoxic CD8+ T cells, inhibit the growth of tumors in mice, and enhance the efficacy of PD-1 inhibitors in mice. Furthermore, another preclinical study of our center shows that efavirenz can enhance the anti-tumor immune response by inhibiting the retrotransposon of LINE-1 and decreasing intratumor heterogeneity. The combination of efavirenz and PD-1 inhibitors effectively inhibits tumor growth in mice. Based on preclinical studies, the investigators designed this study to enroll mTNBC patients who have progressed during or following immunotherapy, and to explore the efficacy of sodium cromoglicate, choline, or efavirenz combined with immunotherapy at a clinical level, providing new strategies of combined treatment for TNBC patients.

Reverse Triple Negative Immune Resistant Breast Cancer

Mast cell function will be measured in pretreatment tissues to predict therapy response.

The expression of ZNF689 will be measured in pretreatment tissues to predict therapy response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bladder Cancer and Neoadjuvant Chemotherapy Efficiency Before Cystectomy	NCT06294054	Bladder Cancer Genomic Instabi...	neoadjuvant che...	18 Years - 80 Years	University Hospital, Rouen
An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.	NCT04395989	TNBC - Triple-N...	A1: Pyrotinib w... A2: nab-paclita... B1: everolimus ... B2: nab-paclita... C1: PD-1 with n... C2: nab-paclita... D1: VEGFR and n... D2: nab-paclita... E1: everolimus ... E2: nab-paclita...	18 Years - 70 Years	Fudan University
FUSCC Refractory TNBC Platform Study (FUTURE2.0)	NCT05749588	Triple-negative...	A1: SHR-A1811 A2: SHR-A1811 w... B1: TROP2 ADC B2: TROP2 ADC w... C1: SHR-A1811 C2: SHR-A1811 w... D1: TROP2 ADC D2: TROP2 ADC w... E1: SHR-A1811 F1: TROP2 ADC G1: SHR-A1811 H1: TROP2 ADC	18 Years -	Fudan University
An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.	NCT04395989	TNBC - Triple-N...	A1: Pyrotinib w... A2: nab-paclita... B1: everolimus ... B2: nab-paclita... C1: PD-1 with n... C2: nab-paclita... D1: VEGFR and n... D2: nab-paclita... E1: everolimus ... E2: nab-paclita...	18 Years - 70 Years	Fudan University
Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery	NCT06363162	Glioma	Immunohistochem...	-	Beijing Tiantan Hospital
Reverse Triple Negative Immune Resistant Breast Cancer	NCT05076682	Triple-negative...	Choline anti-PD-1 antib... Sodium Cromogli... Efavirenz	18 Years - 70 Years	Fudan University
Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery	NCT06363162	Glioma	Immunohistochem...	-	Beijing Tiantan Hospital
Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer	NCT05900206	Breast Cancer	Trastuzumab der... Docetaxel Paclitaxel Carboplatin Trastuzumab Pertuzumab Ribociclib Letrozole Epirubicin Cyclophosphamid...	18 Years -	Karolinska University Hospital

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