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Gastric Cancer clinical trials

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NCT ID: NCT03766945 Recruiting - Gastric Cancer Clinical Trials

Fatigue and QoL Among Gastric Cancer Patients Undergoing Abdominal Surgery

Start date: July 27, 2017
Phase:
Study type: Observational [Patient Registry]

Background: Cancer-related fatigue (CRF), one of the indicators of QoL, is one of the most common side effects of cancer and its treatment. However, the pathophysiological mechanisms involved in CRF among cancer patients are not completely understood. Therefore, more in-depth researches on CRF of surgical patients suffering from gastric cancer are needed in Taiwan. Purpose: The purpose of this study is to examine the incidence rate and correlated factors (QoL and immune biomarkers) of CRF among gastric cancer patients undergoing major abdominal surgery. Method: A longitudinal study was conducted to recruit gastric cancer patients who scheduled to operate at surgical clinics from a northern medical center in Taiwan. The data will be collected with a structured questionnaire and Immune markers assessments via purposive sampling of 120 subjects. Before operation, on day 1 after operation, and on day 7 after operation, the biomarkers will be measured. The BFI-T questionnaire will be filled out before surgery and on day 1, 2, 7, 28 after surgery; The EORTC QLQ-C30 and EORTC QLQ-STO22 questionnaire will be filled out before surgery and on day 7, 28 after surgery; Type D scale-14(Taiwanese version) questionnaire will be filled out before surgery and on day 28 after surgery. Data will be analyzed by using descriptive statistics, paired t-test, Chi square test, Pearson's correlation, and the generalized estimating equation (GEE) was used to identify significant factors with QoL after operation. Anticipated achievement: The anticipated achievement of this study is to provide healthcare providers with more knowledge about CRF, and help them to enhance the quality of life on gastric cancer patients in the future.

NCT ID: NCT03766607 Not yet recruiting - Gastric Cancer Clinical Trials

Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer

Start date: January 31, 2019
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the efficacy and safety of combination therapy with ramucirumab, paclitaxel, and trastuzumab biosimilar as second line treatment of HER2 positive metastatic gastric cancer after failure of first line chemotherapy including trastuzumab. This study is a phase II, single-arm, open label, multi-center study.

NCT ID: NCT03760822 Recruiting - Gastric Cancer Clinical Trials

Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients

SOCRATE
Start date: November 16, 2018
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed. The co-primary endpoints are the following: - Six months survival rate - Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future

NCT ID: NCT03756597 Recruiting - Prostate Cancer Clinical Trials

PAN-study: Pan-Cancer Early Detection Study (PAN)

Start date: September 26, 2018
Phase:
Study type: Observational

The PAN Cancer Early Detection study is a prospective cross-sectional observational case-control study evaluating whether Breath Biopsy (developed by Owlstone Medical Ltd.; the Sponsor of this study) can differentiate between patients with and without different cancer types, by comparing breath biomarkers of patients with gastric, oesophageal, pancreatic, renal, prostate and bladder cancer from matched controls. In total 82 cases (cancer) and 82 matched controls for each tumour type will be recruited at Cambridge University Hospitals NHS Foundation Trust, with an additional 164 healthy volunteers. Participants who consented to participation will be asked to provide 1 breath sample, using the ReCIVA breath collector (developed by Owlstone Medical Ltd. and CE-marked). For controls and cases,medical metadata (general medical history) will be collected as well as information on the diagnostic work-up and follow up data (general health data, details on therapy response for patients with confirmed cancer diagnosis, development of a malignancy during follow-up for matched controls) on the basis of the participant's medical charts. Follow-up data will be collected up to 12 months after the breath sample was collected. For healthy volunteers, clinical metadata and a telephone based follow up at 6 and 12 months will be collected. In a small subset of 15% of the participants, up to additional 4 breath samples will be collected to contribute to the development of a validated assay that can then be validated in further studies. The anonymised breath samples will be analysed at the clinical laboratories of Owlstone Medical Ltd. in Cambridge. The study is a collaboration effort between Owlstone Medical Ltd., Cancer Research UK and University Cambridge Hospitals NHS Foundation.

NCT ID: NCT03746704 Not yet recruiting - Gastric Cancer Clinical Trials

Study of ImmunoPet Imaging of PD-L1 in Tumors Using 89Zr-DFO-REGN3504 in Patients With Advanced Thoracic Malignancies

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

The primary objective of the study is to determine the safety and tolerability of 89Zr-DFO-REGN3504. The secondary objectives of the study are: Study Part A only: - To establish adequate mass dose and activity dose of 89Zr˗DFO˗REGN3504 and optimal post-infusion imaging time, as assessed by imaging and blood draw after tracer infusion Study Part B only: - To establish test/re-test reliability of positron emission tomography (PET) measures as assessed on 2 separate tracer infusions at adequate mass dose and optimal imaging time point as determined in Part A - To characterize the pharmacokinetic (PK) profile of 89Zr˗DFO˗REGN3504 based on tracer plasma activity concentration

NCT ID: NCT03745326 Recruiting - Pancreatic Cancer Clinical Trials

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12D Variant of Mutated RAS in HLA-A*11:01 Patients

Start date: December 12, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Background: A new cancer therapy takes white blood cells from a person, grows them in a lab, genetically changes them, then gives them back to the person. Researchers think this may help attack tumors in people with certain cancers. It is called gene transfer using anti-KRAS G12D mTCR cells. Objective: To see if anti-KRAS G12D mTCR cells are safe and cause tumors to shrink. Eligibility: Adults ages 18-70 who have cancer with a molecule on the tumors that can be recognized by the study cells Design: Participants will be screened with medical history, physical exam, scans, photography, and heart, lung, and lab tests. An intravenous (IV) catheter will be placed in a large vein in the chest. Participants will have leukapheresis. Blood will be removed through a needle in an arm. A machine will divide the blood and collect white blood cells. The rest of the blood will be returned to the participant through a needle in the other arm. A few weeks later, participants will have a hospital stay. They will: - Get 2 chemotherapy medicines by IV over 5 days. - Get the changed cells through the catheter. Get up to 9 doses of a medicine to help the cells. They may get a shot to stimulate blood cells. - Recover in the hospital for up to 3 weeks. They will provide blood samples. Participants will take an antibiotic for at least 6 months. Participants will have several follow-up visits over 2 years. They will repeat most of the screening tests and may have leukapheresis. Participants blood will be collected for several years.

NCT ID: NCT03745170 Not yet recruiting - Gastric Cancer Clinical Trials

Safety and Efficacy of Sintilimab or Placebo in Combiniation With (XELOX) as First Line Chemotherapy in Gastric Cancer

Start date: November 30, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to estimate overall survival of Sintilimab+ oxaliplatin + capecitabine and placebo+ oxaliplatin + capecitabine, as first-line treatment for advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

NCT ID: NCT03740256 Not yet recruiting - Breast Cancer Clinical Trials

Binary Oncolytic Adenovirus in Combination With HER2-Specific CAR VST, Advanced HER2 Positive Solid Tumors (VISTA)

VISTA
Start date: January 1, 2019
Phase: Phase 1
Study type: Interventional

This study involves patients with a type of cancer called HER2 (Human Epidermal Growth Factor Receptor 2) positive cancer. Because there is no standard treatment for this cancer at this time or because the currently used treatments do not work fully, this study asks patients to volunteer to take part in a research study investigating the safety and efficacy of using special immune cells called HER2 chimeric antigen receptor-modified Adenovirus-specific cytotoxic T lymphocytes (HER2-AdVST), in combination with intra-tumor injection of CAdVEC, an oncolytic adenovirus that is designed to help the immune system including HER2-AdVST react to the tumor. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: oncolytic adenovirus (CAdVEC) and T cells (HER2-AdVST). CAdVEC is an oncolytic adenovirus that has been modified to include additional immune system stimulators. Specifically, genes that stimulate the immune system have been added to the oncolytic adenovirus. Oncolytic adenoviruses are viruses that are made to target and kill cancer cells without killing normal cells. Other oncolytic adenoviruses have been used in patients before however CAdVEC has not. In this study, CAdVEC will be injected into participants tumor at one tumor site which is most easiest to reach. Once the oncolytic adenovirus infects the cancer cells, the genes will be expressed, resulting in activation of the immune response so it can attack and kill cancer cells. However, because this approach may have limited effects on the other tumor sites that have not received the oncolytic virus injection, patients will also receive specific T cells following the intratumor CAdVEC injection. These T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells. Investigators have found from previous research that investigators can put a new gene into T cells and make them specifically recognize and kill cancer cells expressing HER2. In the past patients have signed a consent form that allowed us to put on their T cells the HER2 chimeric receptor with viral antigen receptor on their T cells. Investigators want to see if these cells can survive in a patients blood and affect the tumor. Although HER2 chimeric antigen receptor modified cytotoxic T lymphocytes have been used in patients before, HER2-AdVST has not.

NCT ID: NCT03734926 Not yet recruiting - Colorectal Cancer Clinical Trials

A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors

Start date: November 20, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics, and determine the maximum tolerated dose of ZSP1241 in participants with hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumors.

NCT ID: NCT03733639 Not yet recruiting - Gastric Cancer Clinical Trials

Tisseel® as a Reinforcement of Esophagojejunal Anastomoses

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Background: The dehiscence of esophagojejunal anastomoses is one of the most serious complications after total gastrectomy in patients with gastric cancer. Any method of avoiding this problem will affect not only the postoperative course but also the prognostic of disease. Methods: This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Group, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer. The rate of anastomosis leak will be measured with clinical, radiological and analytic parameters. Objective: Analyze the efficacy of Tisseel® as a reinforcement in reducing the rate of anastomotic esophagojejunal anastomoses.