Active clinical trials for "Carcinoma"

This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.

The aim of the study is to test whether a resource-sparing 4-week, 20-fraction course of accelerated hypofractionated radiotherapy is non-inferior to accelerated radiotherapy delivering 33 fractions over 5.5 weeks in the treatment of patients with Stage I-IV squamous cell carcinoma of the pharynx, larynx and oral cavity with the exception of paranasal sinus, nasopharyngeal and stage I-II glottic carcinomas.

This study is being carried out to assess the best dose of a new drug, called tefinostat, in treating liver cancer. Tefinostat is a new drug that blocks enzymes called histone deacetylases (pronounced dee-as-et-isle-azes). Cells need these enzymes to grow and divide. Blocking them may stop cancer growing. Drugs that block these enzymes are called histone deacetylase inhibitors or 'HDAC inhibitors'. Tefinostat has never been given to patients with liver cancer before so it isn't known which dose is best at treating liver cancer. To find this out the study will be testing one dose and if that is safe, then test a higher dose and so on. The aim of this study is to find the best dose of tefinostat without causing side effects. The study will be looking closely at any side effects patients might experience from this treatment.

Nasopharyngeal carcinoma (NPC) is an Epstein-Barr virus(EBV) related malignancy and is an endemic disease in Southeast Asian countries. EBV had been identified as a therapeutic target in some EBV related cancer such as lymphoma and NPC. In cancer cell, EBV was in latent phase and expressed 8-11 genes for maintaining EBV proliferation. After switching to lytic phase, almost all the EBV encoding genes were expressed including thymidine kinase (TK) and some highly immunogenetic genes. These latent-lytic phase swifter included DNA methyltransferase inhibitors, various histone deacetylase (HDAC) inhibitors, radiotherapy and chemotherapy. Recently, combined chemotherapy and viral lytic therapy, cytolytic viral activation therapy (CVAT) had been shown some promising result in pilot study of NPC. In our patient derived xenograft (PDX) animal model drug sensitivity screening, gemcitabine (GEM) was shown to be the most effective drug. Furthermore, CVAT with GEM + Valproic acid (VPA) + ganciclovir (GCV) maintaining chemotherapy may benefit but reduce chemotherapy related side effect and prolonging treatment response duration. The following phase I clinical trial will be proposed to test the optimal combination of these drugs. Number of patients: total 18 patients are needed Inclusion criteria:(1) used as 2nd line regimen in recurrence/metastasis NPC patients with tissue proved of World Health Organization (WHO) type II or type III.(2) Performance status: eastern cooperative oncology group performance status (ECOG PS) ≤2. Chemotherapy regimen: Gemcitabine (GEM, TTY) + Valproic acid (VPA, generic medicine) for viral activation + Valganciclovir (VGC, Roche) for antiviral medication This treatment cycle of 28 days was repeated maximum 6 times. (Q4wks/cycle, max: 6 cycles) Dosage: (1) GEM: 600, 800, 1000, 1250 mg/m^2, D1 & D8, intravenously. (2) VPA 12.5 mg/kg/day D1~14, per os. (3) VGC (2-3) x 450 mg/day D9~15, per os. 6. Objectives: primary: to find the best combination of these 3 drugs in recurrent/metastatic NPC patients. second: to evaluate the response and disease control rate in this pilot study. Key words: NPC, cytolytic viral activation therapy, gemcitabine, valproic acid, ganciclovir.

Esophageal squamous cell carcinoma (ESCC) is one of the ten leading cancers in Taiwanese male. The prognosis is poor with a five-year overall survival rate of 10 to 30 %. Randomized clinical trials have demonstrated that trimodality therapy (TMT), consisted of neoadjuvant concurrent chemoradiation (CCRT) and radical esophagectomy, improves the overall survival for patients with locally advanced disease. Despite of the advancement, the outcome remained unsatisfactory with the median progression-free survival around 20 to 25 months and median overall survival around 30 months. It is know that the most important prognostic factor is whether a pathological complete response can be achieved after neoadjuvant CCRT. However, the use of new generation chemotherapeutic agent taxanes and epidermal growth factor inhibitors (such as Cetuximab) failed to significantly improve prognosis comparing to the standard platinum-fluorouracil (PF) regimen. As a consequence, it is mandatory to develop new chemotherapeutic regimen for CCRT. In previous prospective studies, investigators used proximal ligation assay technology to identify serum VEGF-A in correlation with the pathological response and prognosis for patients receiving neoadjuvant CCRT plus radical esophagectomy for locally advanced ESCC. Other investigators also showed high VEGF expression correlating to poor outcome. Therefore, investigators generate the hypothesis that adding vascular endothelial growth factor (VEGF) monoclonal antibody, Bevacizumab, to standard neoadjuvant CCRT may improve outcome for patients with ESCC. Meanwhile, several prospective clinical studies have shown the feasibility, safety, and activity of adding Bevacizumab to chemotherapy, CCRT, or combined modality therapy including surgery, either in head and neck cancer, esophageal cancer, or esophagogastric junction adenocarcinoma. However, its efficacy should be further investigated in larger prospective trials and little is known about the activity and toxicity of Bevacizumab in ESCC due to small number of reported cases. In the present clinical trial, investigators plan to investigate whether incorporation of Bevacizumab into standard neoadjuvant PF-CCRT will improve treatment response and increase pathological complete response rate. Investigators will also evaluate associated biomarkers in relation to prognosis. By the present research, investigators expect to develop a new TMT regimen for this poor prognostic disease.

Squamous cell carcinoma of the head and neck, which accounts for 90% of head and neck cancers, is the tenth most common cancer worldwide with over 650000 new cases per year. The major risk factors for HNSCC development comprise alcohol and tobacco consumption. During the last decades human papilloma virus infection (HPV) has been identified to contribute to the development of oropharyngeal HNSCC in a subgroup of patients5. Standard treatment options include surgery, (chemo)radiation and chemotherapy. Despite improvements of treatment regimens the recurrence rate of stage III/IV disease after curative therapy is about 30-40%. In locoregionally unresectable recurrent or metastatic disease palliative poly-chemotherapy is the mainstay of therapy.The median survival time of these patients is 6-8 months. Based on the results of the EXTREME study a combination regimen containing a platinum drug, 5 fluorouracil (5-FU) and weekly cetuximab has become standard of care in this setting. For patients, who progressed after platinum based therapy, treatment options are scarce. Besides platinum drugs, taxanes such as paclitaxel or docetaxel were shown to be of particular use in this setting. Apart from that there has been increasing preclinical and clinical evidence that immune-checkpoint inhibitors such as pembrolizumab might play a role in HNSCC. Thus, it is the aim of this study to test if the combination of docetaxel and pembrolizumab after platinum failure is an effective and safe regimen.

The present study is designed as a two arm randomized trial to evaluate the impact of accelerated radiotherapy delivered by image guided radiotherapy with rapid arc technique in carcinoma nasopharynx. The study will evaluate a pure acceleration schedule of 6 fractions per week with concurrent chemotherapy and without any radiotherapy dose escalation.The control arm will receive standard chemoradiotherapy using image guided radiotherapy with rapid arc technique.

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug-delivery system developed to deliver, effectively and safely, small doses of cytotoxic agents into peritoneal tumor deposits. It is currently used for palliation and for down-staging of patients who are non-eligible for cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC). The aim of this study is to evaluate the efficacy of PIPAC used in neoadjuvant setting to enhance the response of patients with colorectal peritoneal metastasis when combined with neoadjuvant systemic therapy for patients eligible to CRS/HIPEC prior to planned surgery.

Niraparib is an oral, potent and highly selective PARP1/2 inhibitor. It can be used as a single drug in HRD positive ovarian cancer patients for multi-line therapy. Bevacizumab is a recombinant humanized monoclonal antibody that inhibits tumor angiogenesis and is also recommended for the treatment of recurrent ovarian cancer. Clinical studies showed that niraparib combined with bevacizumab could significantly prolong progression free survival of platinum sensitive recurrent ovarian cancer. We intend to conduct a single-arm, prospective, open-label, phase II study to observe the efficacy and safety of niraparib combined with bevacizumab in the treatment of FIGO III/IV platinum refractory/resistant ovarian cancer, fallopian tube cancer and primary peritoneal cancer. The results are expected to provide more effective and precise treatment for platinum resistant recurrent/refractory ovarian cancer patients.

This is a single-arm, multicenter phase II clinical study. The aim is to evaluate the safety, tolerability, and anti-tumor activities of AK104(a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced gastric adenocarcinoma and colorectal cancer during the perioperative period.Eligible patients will receive AK104 for three cycles before surgery and at most 6 months after surgery. The primary endpoint is the pathological complete response rate.