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NCT ID: NCT04801082 Not yet recruiting - Pain Management Clinical Trials

Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

Start date: March 2021
Phase: Phase 4
Study type: Interventional

Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. It can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. The effect of CPN has been well established by some retrospective series. The overall response rate to CPN ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. It is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection. Recently, radiofrequency ablation (RFA) of coeliac plexus has been introduced as another mode of CPN. So far, only one small single center randomized controlled trial (RCT) suggesting superior performance in favour to CPN using RFA. This result has to be validated and by a RCT with larger sample size. In addition, data concerning the quality of life (QOL) improvement and cost-effectiveness need to be further elucidated. Therefore, the aim of this study is to perform a RCT to look into these issues.

NCT ID: NCT04780529 Not yet recruiting - Clinical trials for Malignant Neoplasms of Digestive Organs

CART Therapy in Digestive System Tumors

Start date: March 2021
Phase: N/A
Study type: Interventional

Chimeric Antigen Receptor T Cells (CART) Therapy in GUYC2C postive Digestive system tumors, include colorectal cancer, gastric cancer, liver cancer, pancreatic cancer, adenocarcinoma of esophagus, cancer of the esophagogastric junction. Ict-gc is an open, single-center study to evaluate the safety and efficacy of CAR-T-targeted therapy in patients with advanced gastrointestinal tumors.

NCT ID: NCT04773327 Not yet recruiting - Clinical trials for Gynecologic Malignant Tumor

Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

Start date: May 2021
Phase: N/A
Study type: Interventional

This study is a multi-center, forward-looking, open, randomized, controlled clinical trial. This study aims to analyze the effects of Mecapegfilgrastim Injection prevention versus non-prevention for neutropenia in ovarian cancer, cervical cancer, endometrial cancer patients after chemical therapy. Patients are randomized into study group and control group. All patients receive PTX+platinum chemotherapy of 3 weeks. In study group, patients accept PEG-rhG-CSF 24-48 hours from the chemotherapy. While the control group patients are only observed closely. Patient receive three courses of treatment. The primary end is the incidence of 3/4 level neutropenia in three courses of chemotherapy. The secondary ends include: the incidences and duration of neutropenia in every course of chemotherapy, the incidences of FN in three courses and every course of chemotherapy, the incidences of infection in three courses and every course of chemotherapy, the delay time of the next cycle of chemotherapy due to FN or infection, the RDI of the second and third cycles of chemotherapy, adverse events related to G-CSF, quality of life, cost of medicine and admitting.

NCT ID: NCT04767308 Not yet recruiting - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies

Start date: March 2021
Phase: Early Phase 1
Study type: Interventional

Current treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Chimeric antigen receptor (CAR) T cells against CD5 offer another potential therapeutic option for patients with relapsed/refractory CD5 positive hematopoietic malignancies. In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ hematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR/Cas9 genome editing technology to prevent fratricide during CAR T cells manufacturing.

NCT ID: NCT04715191 Not yet recruiting - Liver Cancer Clinical Trials

Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors

Start date: July 3, 2024
Phase: Phase 1
Study type: Interventional

Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called CARE T cells, a new experimental treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that they can put a new gene (a tiny part of what makes-up DNA and carries a person's traits) into T cells that will make them recognize cancer cells and kill them. In the lab, investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GPC3. The antibody GPC3 recognizes a protein found solid tumors including pediatric liver cancers. This CAR is called GPC3-CAR. To make this CAR more effective, investigators also added two genes that includes IL15 and IL21, which are protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 plus IL21 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15 plus IL21 .This study will test T cells that investigators made (called genetic engineering) with GPC3-CAR and the IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors. T cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The investigators will insert the iCasp9 and IL15 plus IL21 together into the T cells using a virus that has been made for this study. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. The investigators will use this drug to kill the T cells if necessary due to side effects. This study will test T cells genetically engineered with a GPC3-CAR and IL15 plus IL21 (CARE T cells) in patients with GPC3-positive solid tumors. The CARE T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of CARE T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the CARE T cells will help people with GPC3-positive solid tumors.

NCT ID: NCT04707365 Not yet recruiting - Colorectal Cancer Clinical Trials

Microenvironment and Immunity of Digestive Cancers - East Paris Multicentric Cohort

MICADO
Start date: March 2021
Phase: N/A
Study type: Interventional

Colorectal and pancreatobiliary cancers are the most common digestive cancers. Their incidence has particularly increased over the last few decades, leading to suspicion that environmental factors are involved. In addition, strategies for the therapeutic management of these cancers are evolving in the context of the development of immunotherapies. Tumor microenvironment is a potential source of new diagnostic, prognostic and predictive markers and new therapeutic targets. The links between tumor microenvironment and modulation of the immune system in colorectal and pancreatobiliary cancers are poorly understood. Molecular classifications have been proposed for these cancers, but their link with immunity and response to treatment remains to be explored. Objective : explore links between molecular subtypes, tumor microenvironment, host (immune system, pre-metastatic niche, intestinal microbiota, metabolism), and survival (prognostic value), response (predictive value) and tolerance (toxicities) to treatments in digestive cancers, in particular colorectal and pancreatobiliary cancers. Method: Retrospective and prospective monocentric cohort study

NCT ID: NCT04673305 Not yet recruiting - Clinical trials for Cognitive Impairment

Cognitive Status Assessment In Elderly Patients With Active Treatment For Haematological Malignancies

Start date: March 2021
Phase: N/A
Study type: Interventional

BACKGROUND Neurocognitive symptoms have a high prevalence in cancer patients, resulting in a significant impact on daily life and tolerance to therapy. It's estimated that about 30% of cancer patients present a cognitive impairment before treatment, about 75% present this cognitive impairment during the treatment, and about 35% continue to present cognitive difficulties in the following months/years. There is growing evidence that cognitive symptoms have a biological mechanism linked to the activation of immunological cytokines that exert important effects on the brain functions. For example, interferon α is known to increase the levels of IL-1, IL-6 and TNF-α, and this increase is associated with memory deficits, executive function and mood alterations. A neurotoxic action induced by cytokines has been demonstrated both in the early stages of the tumor and after chemotherapy. Several imaging studies suggest that the cognitive impairment pattern in cancer patients, during the treatment and in remission, is related to structural and functional brain changes. Longitudinal studies in women with breast cancer treated with chemoterapy have shown a reduction in the volume of cerebral gray matter, mainly in the bilateral frontal cortex and hippocampus. In parallel, diffusion tensor imaging studies have shown an alteration of the integrity of the frontal, parietal and occipital cerebral white matter, demyelination and axonal degeneration processes. Finally, functional magnetic resonance studies in cancer patients have shown alterations in the connectivity of the default mode network compared to control subjects. Studies carried out to date, show a prevalent impairment of executive functions and working memory. Cognitive impairment has been studied mainly as a possible adverse effect in women treated with chemotherapy for breast cancer, while there are few studies in the literature on patients with haematological malignancies. STUDY DESIGN The study is targeted to patients ages ≥ 70 years, whith haematological malignancy, who need to start a treatment within 3 months. Once the eligibility criteria have been assessed, the hematologist proposes the enrollment in the study. Once the patient's informed consent has been acquired, a neurological examination is carried out, functional tests required by the protocol are administered. The patient begins, as per clinical practice, the treatment provided for his/her haematological malignancy. Test's evaluation is repeated at 6 months and 12 months after the enrollment. In conjunction with neurological tests, will be performed a venipuncture as per clinical practice, and a blood sample is taken to measure the cytokines involved in inflammatory processes. It is expected that a patient can perform up to a maximum of 3 blood samples for the biological study. STATISTICAL ANALYSIS This is a non-pharmacological, prospective, uncontrolled, open-label single-center interventional pilot study, aimed to describ the progress of cognitive function under treatment for haematological disease. Due to the pilot and exploratory nature of the study and the substantial absence of a specific literature relating to the elderly onco-haematological patient, it is not believed that the conditions exist to be able to formally define the size of the sample. The sample size is arbitrarily fixed at 60 patients. The observation time will be 12 months from enrollment.

NCT ID: NCT04662788 Not yet recruiting - Clinical trials for Hematological Malignancies

Clinical Study on the Safety and Effectiveness of NK Cells/Combined Monoclonal Antibodies in the Treatment of Hematological Malignancies

Start date: January 1, 2021
Phase: Early Phase 1
Study type: Interventional

Clinical study on the safety and effectiveness of NK cells/combined monoclonal antibodies in the treatment of hematological malignancies

NCT ID: NCT04657965 Not yet recruiting - Clinical trials for Hematological Malignancies

LMP1 CAR-T for Patients With LMP1 Positive Infectious Diseases and Hematological Malignancies

Start date: January 15, 2021
Phase: Early Phase 1
Study type: Interventional

A study of LMP1 CAR-T for patients with LMP1 positive infectious diseases and hematological malignancies

NCT ID: NCT04646772 Not yet recruiting - Clinical trials for Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4

Surgery for Locally Advanced Colon Cancer: is it Worth it? A Multicenter Retrospective Analysis.

LACC
Start date: January 1, 2021
Phase:
Study type: Observational

The aim of the present study is to assess the post-operative outcomes (morbidity and mortality) in relation to preoperative data and the oncological outcomes (overall and disease-free survival) in patients with a locally advanced colon cancer (LACC) with the necessity of a multivisceral resection (MVR).