Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Cabazitaxel 15mg/m2 Intravenous (IV)followed by Cisplatin 70mg/m2 IV on day 1 of each 21 day cycle for 4 cycles

Cabazitaxel 15mg/m2 followed by cisplatin 70mg/m2 given intravenously on day 1 of each 3 weekly cycle for 4 cycles prior to radical cystectomy.

Cabazitaxel + Cisplatin chemotherapy

Amit K Bahl

26 patients with invasive primary transitional cell carcinoma of the bladder will receive 4 cycles of combination chemotherapy consisting of Cabazitaxel and Cisplatin both given intravenously on day 1 of each 3 weekly cycle prior to radical cystectomy, to evaluate the overall response rate and to determine whether this approach warrants further research of a phase II/III study.Participation in 2 sub studies will also be offered to the participants.

1. Contrast Magnetic resonance imaging (MRI ) scans will be taken at baseline and after cycle 1 and cycle 3.
2. A pilot sub study involving the circulating tumour cell concentration from blood samples taken at baseline, prior to each cycle of chemotherapy and prior to surgery

Bristol Bladder Trial

A Phase II Trial of Combination Cabazitaxel and Cisplatin Chemotherapy in the Neo-adjuvant Treatment of Transitional Cell Carcinoma of the Urinary Bladder

From date of registration until the date of first documented progression or date of death from any cause whichever came first.

EQ-5D and EORTC QLQC30 and BLM30 will be assessed at baseline and following each cycle of chemotherapy

Common toxicity criteria adverse events (CTC AE ) Version 4.03 will be assessed at baseline and following each cycle of chemotherapy

From the date of registration to the date of death from any cause.

Sanofi

University Hospitals Bristol and Weston NHS Foundation Trust

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Trastuzumab

Paclitaxel

Carboplatin

Pembrolizumab

Docetaxel

Albumin-Bound Paclitaxel

Standard drug: Neoadjuvant treatment : Weekly paclitaxel + carboplatin + pembrolizumab (TCP) followed by EC90 \*4 pembrolizumab

Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite

Standard drug:

EC100 followed by docetaxel + trastuzumab or EC100 followed by paclitaxel + trastuzumab Docetaxel + carboplatin + trastuzumab \*6 folowed by trastuzumab alone

Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite

Standard drug: EC100 paclitaxel or EC100 docetaxel

Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite

biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment

Biopsy

Centralized blood samples will be performed at inclusion + evaluation visits

Blood samples

Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion

Questionnaires

Jean Sebastien FRENEL, MD

Marine TIGREAT

Anne PASTSOURIS, MD

Jean Sébastien FRENEL, MD

Breast cancer (BC) is the most common cancer in women in France with nearly 58,500 new cases and 12,150 deaths estimated in 2018 .

Two major achievements have been made in the last five years for breast cancer patients. The first is therapeutic with the approval of immune checkpoint inhibitors in advanced and early triple-negative BC (TNBC) and the impressive efficacy of new antibody-drug conjugated in all BC subtypes. The second is conceptual with the generalization of adaptive therapeutic strategies guided by pathological responses after neoadjuvant therapy in early TNBC, HER2+, HR+ and BRCA mutated breast cancer. This new paradigm in the treatment of cancer patients completely redefined prognostic factors that were previously established with conventional approaches Pathological response remains a major prognostic factor especially for TNBC and HER2 early breast cancer. However, this parameter is evaluated at the end of neoadjuvant treatment and for patients with residual disease, the prognosis remains poor despite some adaptative strategies.

Our project is to integrate massive and heterogeneous data concerning the disease (clinical and biological data, imaging and histological results (with multi-omics data)) and patient's environment, personal and familial history. These data are multiple and have dynamic interactions overtime. With the help of mathematical units with biological competences and scientific collaborations, our project is to improve the prediction of treatment response, based on clinical and molecular heterogeneous big data investigation.

The main objective of this project is to set up a clinicobiological database prospectively by collecting prospective clinical, biological, pathological and multi-omic data from 300 Patients with early BC treated at the ICO in order to define an algorithm of individual decision for the prediction of the response to this treatment.

Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients

The primary endpoint is the predictive yield of complete pathological response (pCR) after the neoaduvant treatment

The primary endpoint is the predictive yield of Event Free Survial up to 5 years

The primary endpoint is the predictive yield of overall Survival up to 5 years

Institut Cancerologie de l'Ouest

Digestive System Diseases

Symptoms and General Pathology

Carcinoma, Hepatocellular

Recurrence

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Pembrolizumab 200 mg IV once only in the neoadjuvant phase. Pembrolizumab 200 mg IV every 3 weeks in the adjuvant phase.

Each subject will receive administration of pembrolizumab 200mg IV once only before curative treatment such as hepatic resection or radiofrequency ablation, and will receive curative treatment after administration of pembrolizumab. After curative treatment, each subject will receive pembrolizumab 200mg IV every 3 weeks. Treatment will continue until tumor recurrence, occurrence of an unacceptable adverse event, or the 16th treatment with pembrolizumab.( The setting of 16 times administration is the period of adjuvant therapy of this trial is 12 month(=48weeks), administration of pembrolizumab is Q3W, so 16 times administration comes to 48 weeks.)

Kazuomi Ueshima, Lecturer

Masatoshi Kudo, Professor

The aim of this study is to elucidate the utility of the immune checkpoint inhibitor pembrolizumab in preventing the recurrence of HCC when administered before and after curative surgery or ablation.

Each subject will participate in the trial from the time he or she signs the informed consent form until the final contact. After a screening phase of up to 28 days, each subject will receive administration of pembrolizumab 200mg IV once only before curative treatment such as hepatic resection or radiofrequency ablation, and will receive curative treatment after administration of pembrolizumab. After curative treatment, each subject will receive pembrolizumab 200mg IV every 3 weeks. Treatment will continue until tumor recurrence, occurrence of an unacceptable adverse event, or the 16th treatment with pembrolizumab.( The setting of 16 times administration is the period of adjuvant therapy of this trial is 12 month(=48weeks), administration of pembrolizumab is Q3W, so 16 times administration comes to 48 weeks.) Subjects who discontinue for reasons other than tumor recurrence will have post-treatment follow-up visits for monitoring disease status until tumor recurrence, until initiation of non-study cancer treatment, until withdrawal of consent for study participation, or until becoming lost to follow-up. All subjects will be followed for overall survival until death, withdrawal of consent for study participation, or the end of the study, whichever comes first. After the end of trial treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment or for 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier.

Pembrolizumab as Neoadjuvant Treatment in HCC

Neoadjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma With Pembrolizumab Trial (AURORA)

One-year recurrence-free survival rate is defined as the recurrence-free survival rate 1year after curative treatment.

Recurrence-free survival is defined as the length of time from the date of confirmation of complete cure to the earliest of the following: the date when recurrence is diagnosed or the date of death due to any cause.

Overall survival is defined as the length of time from the date of confirmation of complete cure to the date of death due to any cause.

Tumor assessment in accordance with RECIST1.1 will be performed after neoadjuvant administration.

Baseline levels of tumor markers including AFP, AFP-L3, and PIVKA-II and changes in their levels will be exploratory investigated in relation to the therapy efficacy.

The safety endpoints of this study are the safety of pembrolizumab as neoadjuvant and/or adjuvant therapy in patients with HCC. To determine the safety of the drug, the degree of toxicity is evaluated in accordance with the CTCAE (version 4.0).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bristol Bladder Trial	NCT01616875	Infiltrating Bl...	Cabazitaxel + C...	18 Years -	University Hospitals Bristol and Weston NHS Foundation Trust
Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients	NCT05981326	Breast Cancer	Biopsy Blood samples Questionnaires	18 Years -	Institut Cancerologie de l'Ouest
Bristol Bladder Trial	NCT01616875	Infiltrating Bl...	Cabazitaxel + C...	18 Years -	University Hospitals Bristol and Weston NHS Foundation Trust
Bristol Bladder Trial	NCT01616875	Infiltrating Bl...	Cabazitaxel + C...	18 Years -	University Hospitals Bristol and Weston NHS Foundation Trust
Pembrolizumab as Neoadjuvant Treatment in HCC	NCT03337841	Hepatocellular ...	Pembrolizumab	20 Years -	Kindai University

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