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Neoplasm Metastasis clinical trials

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NCT ID: NCT05384184 Recruiting - Clinical trials for Colorectal Cancer Metastases and Hepatocellular Carcinomas

Next Generation " Pre-clinical Model for Colorectal Cancer Metastases and Hepatocellular Carcinomas (BORG)

BORG
Start date: June 6, 2019
Phase:
Study type: Observational

Recently, oncology has moved to a new clinical practice, more personalized, called Predictive Oncology (PO). PO comes from our knowledge about tumor heterogeneity that implies that each disease, thus each patient, is unique. PO's goal is to identify and administrate the right treatment to the right patient. For this, PO requires to go through 3 majors steps: 1. A good characterization of the tumor to identify candidates, 2. A well-established panel of drugs targeting the identified candidates, 3. A relevant model to functionally test these candidates. The first point could easily be addressed with recent technologies that now allow the Next Generation Sequencing (NGS) and/or the simultaneous analysis of transcriptomic profiles from thousands of patients. The last two points have not been efficiently achieved so far, which prevents PO to be really efficient. Indeed, even if NGS allows the identification of potential targets, the presence of a molecular candidate does not necessary means obligatory functional response. The number of drugs approved by the Food and Drug Administration remains limited and most frequent targets in solid tumors (for ex. RAS, P53, MYC, RB1 ...) still do not have specific drugs approved in clinic. Finally, available pre-clinical models still present many major inconvenient: - Chimiogrammes on 2D cultures are not sufficiently relevant to be really predictive of the in vivo situation; - Patient derived xenograft (PDX) are not adapted for clinical use because not all tumors graft and the time to develop a PDX is too long (several months), thus incompatible with the history of the disease (especially for most severe patients). Furthermore the host (NOD-SCID mouse) is immuno-depressed, preventing to objectively test antibodies-mediated drugs. Recently, the 3D cell culture technology has proven its superiority to predict drug response over classical 2D chimiogrammes. It consists in growing "mini-tissues", or organoid-derived from tumor/healthy tissues, thanks to the amplification of stem cells contained within the sample. The generated organoids are personalized and biologically relevant (organoids are expend form the patient's stem cells which self-organized according to the architecture of the tissue they are originating from), they are genetically stable, their growth is compatible with patient's disease history (organoids grow in few weeks), easy and convenient to achieve, even from small biological material quantities (0.5< x < 1cm3), and they can be amplified, frozen and thawed on demand. Moreover, organoids can be made more complex with the addition of other cell types (fibroblasts, immune cells …). None of the actual available pre-clinical model regroups all these characteristics. The constitution of a "next generation" biobank of liver samples (Metastases to the liver and Hepato Cellular Adenocarcinoma) will be very useful in the context of predictive oncology. For this, a biopsy needs to be dissociated and grown in Matrigel™, in presence of a well-defined list of growth factors. Once the culture is established, organoids can be frozen then defrost on demand. Our main objective is to evaluate the feasibility for building a biobank of liver-derived organoids, from liver metastases of colorectal cancers, hepatocellular adenoma and adenocarcinoma (waste tissues). Applications related to organoids derived from tumors are quasi indefinite, from drug screening assays, tests for novel therapies or original drug combinations, to patients' stratifications or fundamental research. In our case, we are interested in building this a biobank in the prospect of using it to build the "next generation of model for predictive oncology" to study liver-related cancers and related drugs testing. Briefly, we want to implement these organoids with cells from the microenvironment in order to makes the global model more pertinent for drug testing. If successful, the generation of such biobank, including both tumor-derived organoids and healthy counterpart, could be really helpful for the scientific and medical community.

NCT ID: NCT05379790 Recruiting - Gastric Cancer Clinical Trials

Concomitant Intraperitoneal and Systemic Chemotherapy in Patients With Extensive Peritoneal Carcinomatosis of Gastric Origin

Start date: May 25, 2022
Phase: Phase 1
Study type: Interventional

Gastric cancer with peritoneal carcinomatosis has a poor prognosis, with little treatment options available. The current treatment strategy consists of palliative systemic chemotherapy. However, previous research suggests that systemic chemotherapy is less effective against peritoneal carcinomatosis than against metastases that spread hematogenously. Several studies suggested that in patients with peritoneal carcinomatosis, intraperitoneal chemotherapy (IP) may be superior compared to intravenous chemotherapy. Intraperitoneal chemotherapy could lead to higher concentrations of chemotherapy in the peritoneal cavity for a longer period of time, resulting in an increased cumulative exposure to the peritoneal metastases. A few Asian studies have shown promising results with intraperitoneal chemotherapy in patients with peritoneal carcinomatosis of gastric origin. However, intraperitoneal chemotherapy combined with systemic chemotherapy has not been investigated in Western patients with peritoneal carcinomatosis of gastric origin yet. The objective of this trial is to establish the maximum tolerated dose (MTD) of intraperitoneal administration of irinotecan, added to systemic capecitabine/oxaliplatin (CAPOX) in patients with peritoneal carcinomatosis of gastric origin.

NCT ID: NCT05379166 Recruiting - Clinical trials for Secondary Myelodysplastic Syndrome

Venetoclax and Azacitidine for Treatment of Therapy Related or Secondary Myelodysplastic Syndrome

Start date: June 23, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of venetoclax and azacitidine in treating patients with therapy related or secondary myelodysplastic syndrome. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax in combination with azacitidine may work better in treating patients with therapy related or secondary myelodysplastic syndrome.

NCT ID: NCT05378633 Recruiting - Nsclc Clinical Trials

The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?

CyberChallenge
Start date: February 24, 2022
Phase: Phase 2
Study type: Interventional

Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life. Therapy options for multiple brain metastases may vary and range from stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT), chemotherapy, immunotherapy to palliative best supportive care. Especially the efficacy and toxicity of SRS compared to WBRT in patients with extensive brain metastases (>4) is not yet clear but of incremental relevance in this seriously ill cohort with a limited life span. These health-impaired patients might especially profit from a less toxic treatment that is also time sparing with 1 or few sessions in SRS versus 10 sessions in WBRT. On the other hand, no compromises in efficacy want to be done.

NCT ID: NCT05378425 Recruiting - Cancer Clinical Trials

A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab

Start date: September 1, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1,open-label, multi-center, first-in-human, 2-part (Part 1: dose escalation and Part 2: expansion) study, evaluating multiple doses and schedules of intravenously (IV) administered NTX-1088, with or without pembrolizumab, in patients with advanced solid malignancies (i.e., locally advanced or metastatic).

NCT ID: NCT05375994 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients

RAMP204
Start date: August 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.

NCT ID: NCT05362825 Recruiting - Clinical trials for Liver Metastasis Colon Cancer

Surgery Outcome Treated by Neo-adjuvant Combination of Oxaliplatin, Irinotecan, Folinic Acid and Fluorouracil (FOLFOXIRI) Regimen in Synchronous Liver Limited Metastasis Colorectal Cancer

Start date: February 18, 2022
Phase:
Study type: Observational

This single arm study aims to evaluate the rate of conversion therapy in patients with unresectable liver-limited metastatic colorectal cancer (mCRC) using FOLFOXIRI neoadjuvant regimen and to assess the other outcome including the response rate, the survival rate and the safety profile.

NCT ID: NCT05360680 Recruiting - Colorectal Cancer Clinical Trials

A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers

Start date: June 14, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, 2-part, multi-center study evaluating the safety, tolerability, PK, pharmacodynamics (PD), immunogenicity, and antitumor activity of CUE-102 intravenous (IV) monotherapy in HLA-A*0201 positive patients with WT1 positive recurrent/metastatic solid tumors who have failed conventional therapies.

NCT ID: NCT05357417 Recruiting - Breast Cancer Clinical Trials

Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

Start date: April 29, 2022
Phase: Phase 2
Study type: Interventional

This study aims to investigate the efficacy and safety of utidelone in combination with bevacizumab in the treatment of advanced breast cancer with brain metastases, and thus provides a new systemic treatment strategy for those patients.

NCT ID: NCT05354596 Recruiting - Lung Cancer Clinical Trials

A Multicenter Phase II Study of Stereotactic Radiotherapy for Centrally Located Lung Tumors (STRICT-LUNG STUDY) and Ultra-centrally Located Lung Tumors (STAR-LUNG STUDY).

STRICTSTARLUNG
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

An open-label phase II study, investigating toxicity, treatment efficacy and the local tumor control rate in 69 patients with centrally located tumors and in 69 patients with ultra-centrally located tumors in the lung. Treatment and patient outcomes will be recorded. Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation. Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.