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Adenocarcinoma clinical trials

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NCT ID: NCT03764371 Recruiting - Gene Mutation Clinical Trials

Effects of Different Genetic Mutations on Prognosis in sMPLC Adenocarcinoma Patients

Start date: April 22, 2019
Phase:
Study type: Observational

In 2007 and 2013, the American College of Chest Physicians (ACCP) guidelines applied the diagnostic criteria of sMPLC (synchronous multiple primary lung cancers), and the diagnostic criteria of Martini and Melamed were extended and developed, Summarized as: (1) different histological types, different genetic characteristics, or different origin of carcinoma in situ; (2) the histological type is the same, the tumor is located in different lung or different lung lobes, the common lymphatic drainage site of lung cancer is not cancerous, and there is no extrapulmonary metastasis at the time of diagnosis. Postoperative staging of each tumor was carried out in sMPLC patients, if all of them were stage I lung adenocarcinoma, whether adjuvant therapy could fully refer to the treatment principle of stage I NSCLC was considered, whether the benefit of subsequent application of adjuvant chemotherapy was still unclear, and whether adjuvant therapy was needed or not has been determined. High-throughput sequencing, also known as "Next generation" sequencing (NGS), is characterized by sequencing of hundreds of thousands to millions of DNA molecules in parallel, and generally shorter reads.For multiple tumor lesions resected by sMPLC, only biopsy gene information from a single cancer focus may not be enough to identify all active driver gene mutations from the tumor. Therefore, NGS sequencing was proposed for all cancer lesions of sMPLC patients to reflect the full picture of gene mutation in such patients. The investigators initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of NGS technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.

NCT ID: NCT03750669 Recruiting - Clinical trials for Neoadjuvant Chemotherapy

Sequential Use of AG and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer

Start date: October 20, 2018
Phase: Phase 3
Study type: Interventional

The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay the drug resistance and improve the effect of chemotherapy. Here investigators intend to assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox as neoadjuvant chemotherapy for resectable pancreatic adenocarcinoma.

NCT ID: NCT03742869 Recruiting - Clinical trials for Human Papillomavirus

HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma

Start date: November 10, 2018
Phase:
Study type: Observational

This study aims to analyze the multi-omics results between uterine cervical adenocarcinoma patients with and without human papillomavirus (HPV) infections. The multi-omics profiles include genome wide association study (GWAS), whole exome sequencing, analysis of transcriptomics and metabolomics. The HPV integration status is interpreted by GWAS. A comprehensive multi-omics will reveal the role of HPV integration in the molecular mechanism of tumorigenesis and prognosis of uterine cervical adenocarcinoma.

NCT ID: NCT03727880 Recruiting - Clinical trials for Pancreatic Ductal Adenocarcinoma

Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma

Start date: June 4, 2019
Phase: Phase 2
Study type: Interventional

This study will test the effectiveness (anti-tumor activity), safety, and ability to increase the body's immune system to fight pancreatic cancer by combining standard chemotherapy before and after surgery, with study drug PD-1 antibody, pembrolizumab, with and without study drug, focal adhesion kinase inhibitor (FAK), defactinib, in people with "high risk" resectable (surgically removable) pancreatic cancer. The purpose of this study is to evaluate if reprograming the tumor microenvironment by targeting FAK following chemotherapy can potentiate anti-programmed death-1 (PD-1) antibody.

NCT ID: NCT03715933 Recruiting - Sarcoma Clinical Trials

Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Start date: October 10, 2018
Phase: Phase 1
Study type: Interventional

This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).

NCT ID: NCT03709147 Recruiting - Clinical trials for Advanced LKB1-inactive Lung Adenocarcinoma

Metformin Plus/Minus Fasting Mimicking Diet to Target the Metabolic Vulnerabilities of LKB1-inactive Lung Adenocarcinoma

FAME
Start date: October 30, 2018
Phase: Phase 2
Study type: Interventional

Lung adenocarcinoma with inactive LKB1 has emerged as a particularly aggressive form of lung cancer, with poor response to immune checkpoint inhibitors. Recent preclinical evidences have demonstrated that LKB1-inactive lung adenocarcinoma is characterized by specific metabolic vulnerabilities, which make it hypersensitive to energetic crisis. For instance, by inhibiting mitochondrial metabolism and reducing ATP availability to cancer cells, the antidiabetic compound metformin has anticancer activity and prevents acquired resistance to cisplatin in lung adenocarcinoma with inactive LKB1. Similarly to metformin, glucose starvation, which can be recapitulated in vivo by cyclic fasting or fasting-mimicking diet (FMD), can cause metabolic crisis in these neoplasms. In this trial, the investigators will assess for the first time the efficacy of combining standard-of-care platinum-based chemoimmunotherapy with metformin plus/minus FMD in patients with LKB1-inactive, advanced lung adenocarcinoma.

NCT ID: NCT03704662 Recruiting - Pancreatic Cancer Clinical Trials

Preoperative Fractionated Radiation Therapy Versus Stereotactic Body Radiation Therapy for Resectable or Borderline Resectable, or Locally Advanced Type A Pancreatic Adenocarcinoma

Start date: October 22, 2018
Phase: N/A
Study type: Interventional

Patients are randomized into two arms. Arm A patients will receive Stereotactic Body Radiation Therapy (SBRT) and Arm B patients with receive conventional concurrent chemotherapy and radiation therapy.

NCT ID: NCT03703089 Recruiting - Clinical trials for Pancreatic Adenocarcinoma

Gemcitabine & Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology

Start date: May 1, 2018
Phase: Phase 1
Study type: Interventional

Using gemcitabine and nab-paclitaxel, the investigators hope to establish the differential ability of local and cytologically positive disease to respond to this regimen, and in particular, the frequency of cytologic conversion from positive to negative in such patients. The investigators also can begin to assess the value of maximum local therapy, including surgery, in patients who cytologically convert from positive to negative.

NCT ID: NCT03673423 Recruiting - Clinical trials for Pancreatic Adenocarcinoma

Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer

OBTCPAN
Start date: September 5, 2018
Phase:
Study type: Observational

Assess the degree of vascular involvement is crucial in the diagnostic and therapeutic work-up of pancreatic cancer. NCCN resectability classification is used to stratify patients (in resectable, borderline resectable and non resectable) and is based on contrast-enhanced CT scan images. Unfortunately evaluation of imaging tests may rely on some degree of subjective interpretation by observers implying a fundamental variation in patient's treatments and an irreproducibility of different center study results. This is a multicenter diagnostic study on interobserver agreement on the resectability of pancreatic cancer based upon NCCN criteria. The primary aim of the study will be the assessment of interobserver variability to define vascular invasion and resectability status on CT scans (according to the last version of the NCCN Classification). One hundred and thirty eight consecutive patients, able to produce an informed consent, from 18 years of age, with a non-metastatic pancreatic adenocarcinoma assessed by a contrast-enhanced high-quality CT scan will be enrolled. 69 CT scan studies provided by the centers involved (High volume for pancreatic surgery) will be randomly selected from a pool of 138 of the patients that meet the inclusion criteria. Each study will be independently reviewed by a senior radiologist and a senior surgeon of each center, blinded to patient's clinical history and CT scan report, using NCCN definition of respectability status. A CFR will be filled during the review and send to the study coordinator. The data will be than centrally analyzed to asses interobserver agreement The enrolment phase will last 6 months and the whole study will last 8 months.

NCT ID: NCT03666832 Recruiting - Clinical trials for Metastatic Pancreatic Cancer

Multi-center, Open-label, Phase 1b Clinical Trial to Evaluate the Safety, Tolerability, and Exploratory Efficacy of TEW-7197 in Combination With FOLFOX in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed First-Line Gemcitabine and Nab-Paclitaxel

MP-PDAC-01
Start date: June 17, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

- Inclusion 1. Subjects who are males or females ≥ 19 years of age 2. Subjects who have the following history of first-line gemcitabine and nab-paclitaxel among patients with cytologically or histologically proven metastatic pancreatic ductal adenocarcinoma 3. Subjects who can give written informed consent for participation in this trial after receiving explanations of this trial 4. Subjects who have the following laboratory test values: - bilirubin ≤ 1.5 x ULN (upper limit of normal) - aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN - serum creatinine ≤ 1.5 x ULNor estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault) - partial thromboplastin time (aPTT) ≤ 1.5 x ULN - absolute neutrophil count (ANC) ≥ 1,500 cells/µL - platelet count ≥ 100,000/µL - hemoglobin ≥ 9.0 g/dL 5. Subjects who have at least a 12-week life expectancy at the Investigator's discretion 6. Subjects who have Eastern Cooperative Oncology Group (ECOG)Performance Status 0-1 - Exclusion 1. Subjects who were treated with surgery, radiotherapy, chemotherapy or investigational therapy within 2 weeks (note: placement of biliary stent is allowed) 2. Subjects who have uncontrolled CNS metastases (patients who require steroids should be on a stable or decreasing dose for at least 2 weeks) 3. Subjects who have any contraindications for 5-FU, leucovorin, or oxaliplatin 4. Subjects who have moderate or severe cardiovascular disease - Subjects who have myocardial infarction, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension within 6 months before screening - Subjects who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO results at screening or within 14 days before screening - Subjects who have increase in brain natriuretic peptide(BNP) or increase in troponin (over 99th percentile upper reference limit) at Screening (based on the normal range of relevant study center) - Subjects who have risk factors for ascending aortic aneurysm such as genetic disorder and trauma and risk factors for aortic stenosis - Subjects who have a history of heart or aorta surgery 5. Subjects who have clinically significant gastrointestinal bleeding within 4 weeks before screening 6. Subjects who have a known history or suspected hypersensitivity to any excipients of the investigational product or combination drug(s) 7. Subjects who have received prior treatment targeting the signaling pathway of TGF-β 8. Subjects who have a disease or condition that affects the mechanism of the investigational product, or are currently using or planning to use: - Drugs that are exclusively or primarily eliminated by cytochrome P-450 isozyme (CYP) including CYP1A2, CYP2B6, or CYP3A4 - Drugs that are exclusively or primarily eliminated by UDP glucuronyltransferase (UGT) 1A1 (UGT1A1) - Drugs that are substrates for the drug transporter multidrug resistance protein 1 (MDR1) have a narrow therapeutic window or are strong inhibitors of drug transporter MDR1 - Drugs that are strong inhibitors or inducers of CYP2D6 or CYP3A4 9. Subjects who are unable to swallow tablets 10. Subjects who have a history of or are suspected of drug abuse 11. Female subjects of child-bearing potential who have a positive result on a pregnancy test at screening or are unable to agree to use an effective barrier method of birth control to avoid pregnancy during the study period (e.g., sterilization, intrauterine contraceptive device, combination of oral contraception and barrier contraception, combination of other hormone delivery systems and barrier contraception, contraceptive cream, combination of cream, jelly, or form and diaphragm or condom) 12. Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study 13. Subjects who were treated with other investigational products within 28 days before screening or within a period shorter than 5-timesthe half-life of the investigational product