Intraperitoneal Paclitaxel for Patients With Primary Malignant Peritoneal Mesothelioma - a Phase I/II Dose Escalation and Safety Study
Patients primary malignant peritoneal mesothelioma (MPM), without extra-abdominal disease, that are not eligible (or willing) to undergo cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) can be included in this study. Patients will be treated with intraperitoneal (IP) chemotherapy (paclitaxel) in weekly cycles. The primary aim of this study is to determine the maximum tolerable dose (MTD) of IP monotherapy with paclitaxel for patients with MPM. The secondary aims are to assess safety and feasibility of this strategy, and to study the pharmacokinetics of paclitaxel in this setting.
NCT05449366 — Peritoneal Malignant Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/peritoneal-malignant-mesothelioma/NCT05449366/
Surgery for Mesothelioma After Radiation Therapy Using Exquisite Systemic Therapy
The SMARTEST trial is a phase II non-blinded randomized trial designed to evaluate the benefit of low dose cyclophosphamide in sequential combination with sub-ablative radiation (Arm A) versus sub-ablative radiation alone (Arm B) before surgery as well as the safety and efficacy of consolidation tremelimumab-durvalumab for eligible patients after surgery in both arms.
NCT05380713 — Mesothelioma, Malignant
Status: Recruiting
http://inclinicaltrials.com/mesothelioma-malignant/NCT05380713/
Phase I, Open-Label Study With Dendritic Cell Therapy (MesoPher) In Combination With Ex-tended-Pleurectomy/Decortication After Chemotherapy in Subjects With Resectable Mesothelioma
The ENSURE trial is an open label, single center, phase 1, feasibility study. Sixteen adult patients diagnosed with resectable epithelioid malignant pleural mesothelioma (MPM) will be enrolled following first-line chemotherapy. Before standard-of-care chemotherapy, a leukapheresis will be performed and monocytes will be used for differentiation to dendritic cells (DCs) using specific cytokines. Allogeneic tumor lysate (Pheralys) loaded autologous DCs (MesoPher) will be re-injected 3 weeks after completing chemotherapy, 2 times every other week. Four weeks after the first injection with dendritic cell therapy (DCT), patients will undergo extrapleural pleurectomy/decortication (eP/D) surgery and receive three bi-weekly injections with DCT (starting 4 weeks after surgery). In total, five DC vaccinations will be administered. A tumor biopsy will be collected before starting neo-adjuvant DCT.
NCT05304208 — Mesotheliomas Pleural
Status: Recruiting
http://inclinicaltrials.com/mesotheliomas-pleural/NCT05304208/
Value of Glypican-1 Expression in Pleural Epithelioid Mesothelioma, Adenocarcinoma and Squamous Cell Carcinoma of the Lung
Lung carcinoma is the second most common cancer and a leading cause of cancer-related mortality worldwide. In Egypt, lung carcinoma ranks the 5th among all cancer cases. Malignant mesothelioma is an aggressive neoplasm that arises from mesothelial cells which form the lining of the pleural. There is a strong resemblance between epithelioid mesothelioma and lung adenocarcinoma, some of peripheral lung adenocarcinoma or SCC present with pleurotropic growth like mesothelioma. Glypican-1 (GPC1) is one the six glypican family members. It is one of cell surface heparan sulfate proteoglycans that acts as a growth factor signaling. The aim of this study is to evaluate the immunohistochemical expression of Glypican-1 in pleural epitheloid mesothelioma, lung adenocarcinoma and lung SCC
NCT05228795 — Mesothelioma; Lung
Status: Recruiting
http://inclinicaltrials.com/mesothelioma-lung/NCT05228795/
Assessment of Histologic Prognostic Factors in Peritoneal Malignant Mesothelioma
Malignant peritoneal mesothelioma is a rare neoplasm. The most common type, the epithelioid type, has been further divided into histological patterns of tubulo-papillary, acinar, adenomatoid, micropapillary, or solid. Its prognosis is improved by the use of a locoregional treatment combining extensive cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), which increases survival up to 50 months. Histology is one of the most important prognostic variable that, forms the basis for treatment decisions. However, the prognostic of the epithelioid type varies greatly due to its tumor heterogeneity. It is therefore necessary to find prognostic factors of malignant epithelioid peritoneal mesothelioma in order to better define the therapeutic strategy. Among histological factors, solid growth, tumor necrosis, nuclear atypia, and mitotic count were found to be independent prognostic factors in epithelioid malignant pleural mesothelioma. However, in epithelioid malignant peritoneal mesothelioma (EMPM), these factors were studied in small and heterogeneous series in terms of histological growth and definitions used for histological factors. The present large study was conducted to investigate the prognostic impact of several histologic factors in EMPM. Their prognosis impacts were assessed using overall survival (OS) and progression-free survival (PFS) in EMPM.
NCT05193006 — Peritoneal Malignant Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/peritoneal-malignant-mesothelioma/NCT05193006/
Study of Sintilimab Combined With Anlotinib and Platinum-Containing Dual-Agent Chemotherapy as First Line Therapy in Malignant Pleural Mesothelioma: A Single Arm, Open-label, Prospective Phase II Trial
This study is a single-arm, open-lable, single-center phase II clinical trial for patients with advanced or metastatic pleural mesothelioma. The aim of this study was to observe and evaluate the efficacy and safety of Sintilimab combined with Anlotinib hydrochloride and platinum-containing dual-agent chemotherapy as first-line therapy in malignant pleural mesothelioma.
NCT05188859 — Mesothelioma, Malignant
Status: Not yet recruiting
http://inclinicaltrials.com/mesothelioma-malignant/NCT05188859/
A Phase 1 Study of Pembrolizumab Plus Cryoablation in Patients With Unresectable Mesotheliomas
The researchers are doing this study to find out whether the combination of pembrolizumab and cryoablation is a safe treatment that causes few or mild side effects in people with mesothelioma. The researchers will also look at whether the combination of pembrolizumab and cryoablation is effective against participants' cancer.
NCT05071014 — Lung Cancer
Status: Completed
http://inclinicaltrials.com/lung-cancer/NCT05071014/
Real World Study of Diagnosis, Treatment and Prognosis of Malignant Pleural Mesothelioma in China
Malignant pleural mesothelioma (MPM) is a highly aggressive tumor with atypical clinical manifestations. Most patients with MPM are at an advanced stage at the time of diagnosis, and only a few patients can be cured by radical surgery and other treatment measures. Pemetrexed + cisplatin chemotherapy with or without bevacizumab is still the standard treatment for MPM. In recent years, multimodality therapy including surgery, radiotherapy and chemotherapy have shown certain advantages in improving patient overall survival time. Targeted and immunotherapy may bring breakthroughs in MPM therapy. However, there are still no high-quality evidence-based medical evidence reports on the treatment model and effects of MPM patients in China. Focusing on MPM, we plan to systematically review the relevant scientific literature, confirm relevant scientific research questions, and provide references for related treatments. On this basis, we will estimate MPM incidence and mortality rates from 2014 to 2025 based on the data published by the National Cancer Registry. Meanwhile, a retrospective study cohort was constructed based on the electronic medical record database, and according to the research demand, patients were followed up with their post-discharge survival status to comprehensively describe and analyze the incidence, diagnosis, treatment, and prognosis of MPM patients. Also, exploratory analysis of the therapeutic effects of existing clinical treatments was conducted.
NCT05042557 — Diagnoses Disease
Status: Recruiting
http://inclinicaltrials.com/diagnoses-disease/NCT05042557/
A Phase II Prospective, Open-label Trial of Perioperative Combination Nivolumab and Ipilimumab in Patients With Resectable Malignant Peritoneal Mesothelioma
This study is for individuals who have peritoneal mesothelioma, a cancer of the lining of your abdominal wall and organs (the peritoneum). Doctors leading the study would like to determine the effects of treating this cancer with immunotherapy drugs (nivolumab and ipilimumab - the two study drugs that will be used in this study) before and after surgery. Doctors hope to learn if giving these two drugs before surgery will decrease the amount of viable (live) cancer cells that remain at the time of surgery and whether it will delay the time it could take for the cancer to regrow.
NCT05041062 — Mesothelioma
Status: Completed
http://inclinicaltrials.com/mesothelioma/NCT05041062/
Phase 2 Randomized Trial of Neoadjuvant or Palliative Chemotherapy With or Without Immunotherapy for Peritoneal Mesothelioma
This phase II trial compares the usual treatment alone to using immunotherapy (atezolizumab) plus the usual treatment in treating patients with peritoneal mesothelioma. The usual treatment consists of surgery or chemotherapy. Chemotherapy drugs, such as carboplatin and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with usual treatment may work better than usual treatment alone.
NCT05001880 — Peritoneal Malignant Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/peritoneal-malignant-mesothelioma/NCT05001880/