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Carcinoma, Ovarian Epithelial clinical trials

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NCT ID: NCT04670068 Recruiting - Clinical trials for Epithelial Ovarian Cancer

Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian

Start date: January 27, 2021
Phase: Phase 1
Study type: Interventional

This is single center, open-label phase 1 dose escalation trial that uses modified 3+3 design to identify a recommended phase 2 dose (RP2D) of CAR.B7-H3 T cell product. An expansion cohort will enroll additional subjects at the RP2D for a total enrollment of up to 21 subjects on the protocol.

NCT ID: NCT04665635 Recruiting - Clinical trials for Epithelial Ovarian Cancer

Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Ovarian cancer is the most common cause of death in gynecological cancer. Approximately 75% of epithelial ovarian cancers are detected at an advanced stage. Metastasis and spread are mostly through transperitoneal planting and neighborhood by shedding from the ovarian surface. Metastasis mostly occurs in the peritoneum, omentum, and intestines. The rectosigmoid colon is the main part of the intestine affected by metastasis due to its neighborhood. Treatment in ovarian cancer consists of a combination of cytoreduction surgery and platinum-based chemotherapy. Surgery is the basis of the treatment, and the main goal is to achieve no residual visible tumor (complete cytoreduction: R0). The residual tumor is one of the main factors affecting survival and reflects the possibilities of the surgical center and the team. Multiple surgical procedures (total hysterectomy, bilateral salpingo-oophorectomy, total omentectomy, peritonectomy, retroperitoneal lymphadenectomies such as pelvic and paraaortic, bowel resections, splenectomy, distal pancreatectomy, various resections related to the bladder, liver, stomach, and diaphragm) may be required to achieve complete or optimal cytoreduction. In the involvement of the rectosigmoid colon, primarily the serosa, then the muscular layer and finally the mucosa are infiltrated due to the nature of the spread, and therefore most of the involvement is observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed. There are advantages and disadvantages of each method in terms of morbidity. Although there are retrospective studies evaluating recurrence and survival between both methods, as far as investigators know, no randomized prospective studies have been conducted comparing these two methods. The investigators designed this study to compare these two methods successfully applied in our clinic in a prospective randomized study.

NCT ID: NCT04651946 Recruiting - Clinical trials for Epithelial Ovarian Cancer

Cell-free DNA Methylation for Epithelial Ovarian Cancer

Start date: November 26, 2020
Phase: Phase 2
Study type: Interventional

Liquid biopsy is challenging for the diagnosis of epithelial ovarian cancer (EOC). In this study, we performed the methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in EOC patients. The study compromises two stages. In the training set, DNA methylation testing is performed in the ovarian tissues from EOC and paired benign ovarian tumor patients. The cut-off values of methylation are produced in this stage. On the meantime, serum DNA methylation testing is also performed to reveal its accordance and accuracy compared with the results of ovarian tissues. In the validation set, serum DNA methylation testing is performed in unselected ovarian tumor patients with definite cut-off values to validate its accuracy based on known histology of ovarian tumors. In training and validation sets, serum DNA methylation is also performed after major surgeries for EOC as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.

NCT ID: NCT04651933 Recruiting - Clinical trials for Epithelial Ovarian Cancer

A Training Set for the HRD Model in EOC

Start date: November 26, 2020
Phase:
Study type: Observational

A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH) is little explored in epithelial ovarian cancer (EOC) patients. This study would recruit 200 Chinese EOC patients with known BRCA1/2 mutation status and resistance to platinum-based chemotherapy. A LOH-HRD model is to be constructed based on the genetic testing in these patients. The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients, and a potential explanation of platinum-resistance in such population.

NCT ID: NCT04644289 Recruiting - Clinical trials for Epithelial Ovarian Cancer

WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

WoO
Start date: May 5, 2022
Phase: Phase 2
Study type: Interventional

This is a multi-center, prospective, open-label, phase II trial. Patients with suspected advanced ovarian cancer planned to undergo diagnostic laparoscopy for histologic confirmation and evaluation of disease spread will be registered into the trial after providing a 1st written informed consent.

NCT ID: NCT04620954 Recruiting - Clinical trials for Epithelial Ovarian Cancer

Clinical Trial of Chemotherapy, Oregovomab and Nivolumab in Patients With Epithelial Cancer of Ovarian, Tubal or Peritoneal Origin

ORION-02
Start date: October 7, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, single-arm, phase I/II, single-center study with dose finding and dose expansion parts. This study hypothesizes that the combination of platinum-based chemotherapy, Oregovomab and Nivolumab will improve intracellular CA 125 antigen processing and elicit a stronger systemic CA 125-specific T cell response and that it will be in a manner that is synergistic, safe and clinical efficacious in patients with relapsed platinum sensitive epithelial ovarian carcinoma (EOC).

NCT ID: NCT04617470 Recruiting - Ovarian Cancer Clinical Trials

Niraparib as Maintenance Treatment in Platinum Responsive Ovarian Cancer Patients: a Real Life Study

MITO 34
Start date: July 8, 2020
Phase:
Study type: Observational

This is an observational phase IV study evaluating Niraparib as maintenance treatment in patients with platinum sensitive, platinum responsive, recurrent ovarian cancer in a real life setting.

NCT ID: NCT04611126 Recruiting - Peritoneal Cancer Clinical Trials

T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer

Start date: April 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Although immunotherapy has revolutionized the treatment of many cancers, ovarian cancer patients have not yet benefitted from the advances. In two consecutive pilot trials at National Center for Cancer Immune Therapy (CCIT-DK), is has been have shown that adoptive cell therapy (ACT) with TILs for patients with advanced ovarian cancer (OC) is feasible and tolerable. In the most recent of these trials ACT was combined with a CTLA-4 inhibitor, Ipilimumab and a PD1-inhibitor, Nivolumab. Only transient clinical responses where observed. Between 90-100 % of infused T-cells in our previous ovarian cancer ACT trial expressed LAG-3. The interaction between LAG-3 on T-cells and MHC-II on tumor cells inhibits T-cell function. In this study adding the LAG-3 antibody Relatlimab to the ACT-regimen described above may therefore well unleash T-cell antitumor efficacy by blocking the known LAG-3-MHC-II interaction. With this study the aim is to demonstrate that adding the lag-3-inhibitor Relatlimab to the above treatment regimen is feasible and tolerable. The study will elucidate whether the combination Relatlimab-Nivolumab leads to objective responses and improves progression free survival (PFS).

NCT ID: NCT04602377 Recruiting - Clinical trials for Small Cell Ovarian Carcinoma

Addition of Pembrolizumab to the Standard of Care Chemotherapy in Patient With SCCOHT

PembroSCCOHT
Start date: August 4, 2021
Phase: Phase 2
Study type: Interventional

Small cell ovarian carcinomas are rare and have a very poor prognosis affecting a young population. The objective of this study is to increase the efficacy of the initial chemotherapy by providing immunotherapy and to be able to offer to more patients the possibility of benefiting from an intensification of chemotherapy, which is a major prognostic factor in this population.

NCT ID: NCT04590625 Recruiting - Ovarian Cancer Clinical Trials

Apatinib Combined With Abraxane and Carboplatin or Cisplatinum as First-line Treatment for Epithelial Ovarian Cancer

Start date: October 2020
Phase: Phase 2
Study type: Interventional

This monocentric, prospective, observational study will evaluate the safety and efficacy of apatinib in combination with albumin binds paclitaxel and carboplatin or cisplatinum as first-line treatment for stage II-IV epithelial ovarian cancer followed by apatinib maintenance therapy in routine clinical practice. Eligible patients will be followed for approximately 20 months.