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Carcinoma, Ovarian Epithelial clinical trials

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NCT ID: NCT05265117 Recruiting - Ovarian Cancer Clinical Trials

The Efficacy of Hyperthermic Intraperitoneal Chemotherapy to Ovarian Cancer Patients With Homologous Recombination Repair Defect and Residual: a Prospective Cohort Study

Start date: April 1, 2022
Phase:
Study type: Observational

Ovarian cancer is associated with the highest mortality of all gynecologic cancers. In patients with newly diagnosed advanced ovarian cancer after platinum-containing chemotherapy plus bevacizumab therapy, maintenance therapy with olaparib plus bevacizumab significantly prolongs progression-free survival (PFS) in the intended population and is recommended by guidelines. However, study shows those homologous recombinant repair defect (HRD) but Breast Cancer Susceptibility Gene(BRCA) wild type have limited benefit from maintenance therapy with olaparib plus bevacizumab when surgery is with residual(no-R0). Can hyperthermic intraperitoneal chemotherapy(HIPEC) improve the benefits of first-line maintenance therapy in patients with non-R0 resection, HRD? The cohort study will enroll 310 patients with HRD and no-R0 resection who conduct HIPEC during primary treatment and then have olaparib plus bevacizumab as maintenance. Follow-up period is 30 months. The primary endpoint is PFS.

NCT ID: NCT05255861 Recruiting - Ovarian Cancer Clinical Trials

An Exploratory Study of HRD Score in Chinese Ovarian Cancer Patients Benefiting From PARP Inhibitor Targeted Therapy

Start date: March 1, 2022
Phase:
Study type: Observational

This project intends to evaluate the sensitivity of different Homologous Recombination Deficiency (HRD) score to Poly(ADP-ribose) polymerase inhibitor (PARPi) by retrospectively analyzing the tissue samples of patients with ovarian cancer using PARPi, and to determine the cut off value of the HRD score algorithm suitable for the Chinese population, so as to provide evidence for the role of PARPi in ovarian cancer. The screening of the beneficiaries of maintenance therapy provides precise guidance and can be used as a reference for other cancer types.

NCT ID: NCT05255471 Recruiting - Ovarian Cancer Clinical Trials

MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.

MITO 35B
Start date: January 21, 2022
Phase: Phase 3
Study type: Interventional

MITO 35b is designed as randomized, open label, phase III trial that aims to assess the efficacy of olaparib maintenance beyond progression compered to standard platinum-based chemotherapy after secondary cytoreductive surgery. The target population of this study are ovarian cancer patients who experience a disease recurrence or progression to a first line maintenance therapy with PARPi; at progression patients must have received a secondary cytoreduction according to clinical practice.

NCT ID: NCT05251883 Recruiting - Ovarian Cancer Clinical Trials

A Study to Analyze Data on Metastatic Ovarian Cancer Using Multi-omics

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

As one of the most common malignant tumors in women, the incidence of ovarian cancer is expected to increase year by year. Due to its lack of typical symptoms and effective screening methods, and the characteristics of implantation and distant metastasis, more than 70% of ovarian cancers were in the metastatic stage at the time of diagnosis. In this study, the investigators will collect large samples of tissue from patients with ovarian cancer, conduct multi-omics studies, and mapped the characteristic maps of the genome and transcriptome of patients with metastatic ovarian cancer, and explore the molecular mechanisms that can be used as new targets for the treatment of ovarian cancer. Besides, the investigators will design and establish a database of metastatic ovarian cancer, integrate multiple omics, imaging, pathology, and clinical information to study their potential relevance, and analyze the relationship between various omics, imaging, pathology, and prognosis, establish ovaries Cancer prediction model.

NCT ID: NCT05246020 Recruiting - Clinical trials for Neoadjuvant Chemotherapy

Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)

NHIPEC
Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

Background: Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone. Methods: This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60-75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.

NCT ID: NCT05231122 Recruiting - Clinical trials for Recurrent Ovarian Carcinoma

Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer

Start date: March 12, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back (recurrent). Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and, when combined with other immunotherapy treatments, may increase antitumor antibody production. Immunotherapy with monoclonal antibodies, such as pembrolizumab and bevacizumab, may help the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms, prolonged survival, and improve quality of life in patients with ovarian cancer.

NCT ID: NCT05226507 Recruiting - Ovarian Cancer Clinical Trials

A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer

Start date: December 31, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the dose escalation phase is to evaluate the safety profile of escalating doses and dose schedules of NXP800. In the expansion phase the preliminary efficacy in subjects with ARID1a mutated ovarian clear cell and ovarian endometrioid cancers will be estimated.

NCT ID: NCT05225363 Recruiting - Clinical trials for Platinum-Resistant Ovarian Carcinoma

Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer

Start date: May 5, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of TAG72-chimeric antigen receptor (CAR) T cells in treating patients with epithelial ovarian cancer that remains despite treatment with platinum therapy (platinum resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize TAG72, a protein on the surface of tumor cells. These TAG72-specific T cells may help the body's immune system identify and kill TAG72+ cancer cells.

NCT ID: NCT05211557 Recruiting - Ovarian Cancer Clinical Trials

Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer

Start date: November 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is single center, open-label phase I, non-randomized study which will enroll patients with recurrent advanced ovarian cancer to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T cells (fhB7H3.CAR-Ts) via using a '3+3+3' dose escalation design. In the dose expansion cohort, six patients will be enrolled to further assess their efficacy with the optimal dosage.

NCT ID: NCT05206890 Recruiting - Ovarian Cancer Clinical Trials

A Non-interventional Registry Study of Fluzoparib in the Treatment of Ovarian Cancer

Start date: January 14, 2022
Phase:
Study type: Observational [Patient Registry]

Ovarian cancer is one of the most fatal malignant tumors that threaten women's health. The incidence rate is the third place among the female reproductive system malignant tumors, and the mortality rate ranks the first in gynecologic malignancies, the majority of patients have advanced diseases at the time of diagnosis. This observational study is to evaluate the safety and efficacy of fluzoparib in ovarian cancer patients under real conditions, especially in various subgroups of ovarian cancer patients, in order to provide information about treatment modes for ovarian cancer patients in real-world diagnosis and treatment, and preliminarily evaluate the pharmacoeconomic of fluzoparib in the treatment of ovarian cancer.