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Stomach Neoplasms clinical trials

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NCT ID: NCT04613570 Recruiting - Gastric Cancer Clinical Trials

SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up

SUPREME
Start date: January 2, 2021
Phase: N/A
Study type: Interventional

Introduction: Gastric atrophy and intestinal metaplasia are the principal precursors for gastric cancer and, therefore, are considered gastric premalignant conditions. Although current guidelines recommend surveillance of individuals with these conditions, the best method for its identification and staging (histological vs endoscopy) and the best time schedule for follow-up are still controversial. Aims: To describe for the first-time patients with premalignant conditions both clinically (familial history), histologically (OLGA/OLGIM; complete/incomplete metaplasia) and endoscopically (EGGIM) using validated scales and to describe evolution of these parameters through time. To estimate prospectively the gastric cancer risk according to EGGIM stages. To define the best endoscopic surveillance follow-up for the several stages considering clinical, histological and endoscopic factors. Methods: Multicenter study involving different gastroenterology departments from several countries. Consecutive patients older than 45 years scheduled for upper endoscopy in each of these centers will be evaluated by High-Resolution- endoscopy with virtual chromoendoscopy and EGGIM will be calculated. Guided biopsies (if areas suspicious of IM) and/or random biopsies (if no areas suspicious of IM) in antrum and corpus will be made and OLGA/OLGIM stages calculated. Patients will be evaluated in clinical consultation and database will be fulfilled. All patients will be eradicated for Helicobacter pylori infection if positive. At that occasion, all the patients with EGGIM>5 and/or OLGA III/IV and/or OLGIM III/IV will be randomized for yearly (12 to 16 months) or every three years (32-40 months) endoscopic follow-up during a period of 6 years (SUPREME I). Endoscopic observational follow-up will be scheduled for patients with EGGIM 1-4 and OLGIM I/II at 3 and 6 years (SUPREME II). For individuals with no evidence of IM (EGGIM 0 and OLGIM 0, OLGA 0-II) a follow-up endoscopy 6 years after will be proposed (SUPREME III).

NCT ID: NCT04609592 Recruiting - Clinical trials for Gastroenteropancreatic Neuroendocrine Tumor

Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery

Start date: March 17, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about the feasibility and safety of using Peptide Receptor Radionuclide Therapy (PRRT) before and after surgical removal of a tumor. PRRT treatment is based on the administration of a radioactive product, 177-Lu DOTA-0-Tyr3-Octreotate (Lutathera®) and its use before and after surgery is thought to increase the overall survival benefit for patients with SSTR-positive gastroenteropancreatic neuroendocrine tumors GEP-NETs.

NCT ID: NCT04609176 Recruiting - Gastric Cancer Clinical Trials

Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Start date: November 18, 2020
Phase: Phase 2
Study type: Interventional

This is a study of Camrelizumab (SHR-1210) and Apatinb for unresectable Recurrent or metastatic alpha-fetoprotein (AFP)-producing gastric cancer or Gastroesophageal Junction Adenocarcinoma. Camrelizumab combined with Apatinib and standard chemotherapy will be given to treatment-naïve participants; Camrelizumab combined with Apatinib will also be evaluated in participants who have had ≥ 1 line of previous treatment. The primary endpoint is the Overall Response Rate (ORR).

NCT ID: NCT04607057 Recruiting - Gastric Cancer Clinical Trials

Supplemental Parenteral Nutrition During Postgastrectomy in Nutritionally at Risk Patient

SUPPORT
Start date: December 22, 2020
Phase: Phase 4
Study type: Interventional

- If a patient undergoes gastrectomy, which is a kind of major abdominal operation, he/she loses more than 5% of his/her body weight in 2 months after surgery. This point is one of the criteria of 'risk of malnutrition' according to Nutrition Risk Screening (NRS 2002) and the patient who corresponds to this criterion needs nutritional support. - According to Nutrition Risk Screening (NRS 2002), moderate malnutrition is defined as the state that the patient orally intakes 25~50% of recommended requirements; severe malnutrition is less than 25%. - Meanwhile, when oral nutrition support was provided to patients after gastric cancer surgery, the patients' average daily intake during the first three months was about a half of the recommended requirements. - Putting together the facts i) that the patient underwent major abdominal operation, ii) that the weight loss rate exceeded 5% for two months, iii) that the average daily intake of patients during the first three months was about half of the recommended amount, the patients are eligible to be classified as a group who require nutritional support according to NRS 2002. Therefore, it is intended to verify the efficacy and safety of supplemental parenteral nutrition by comparing Arm A, who are provided oral intake with supplemental parenteral nutrition, Arm B, who are provided oral intake only after curative gastric cancer surgery.

NCT ID: NCT04600466 Recruiting - Gastric Cancer Clinical Trials

Molecular and Epidemiological Risk Factors in the Development of Gastric Cancer

Start date: January 22, 2021
Phase:
Study type: Observational

This protocol is a single-institution feasibility study to identify the molecular and epidemiological risk factors in the development of gastric cancer in high-risk predominantly Hispanic South Texas population. The study is broken down into two main parts: 1) To identify molecular differences in gastric adenocarcinoma (GAC) between Non-Hispanics and Hispanics, stratified by age, and in benign, pre-malignant, and malignant gastric lesions; and 2) To identify environmental and clinicopathological factors in Hispanics associated with specific molecular changes linked to the development of GAC.

NCT ID: NCT04597294 Recruiting - Gastric Cancer Clinical Trials

Prophylactic Preoperative HIPEC in Advanced Gastric Cancer at High Risk of Peritoneal Recurrence

CHIMERA
Start date: August 1, 2021
Phase: Phase 3
Study type: Interventional

The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.

NCT ID: NCT04595929 Recruiting - Gastric Cancer Clinical Trials

Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With T3-4 Gastric Cancer Cyt-

GASPACCO
Start date: February 10, 2020
Phase: N/A
Study type: Interventional

Stomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.

NCT ID: NCT04593134 Recruiting - Gastric Cancer Clinical Trials

Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

Start date: November 10, 2020
Phase: N/A
Study type: Interventional

This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan. Hypothesis: 1. The fatigue in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month. 2. The negative emotions in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month. 3. The sleep quality in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month. 4. The quality of life in exercise group is significant improving than usual-care group at 1st, 2nd,3rd, 6th, 12th, 24th and 36th month.

NCT ID: NCT04583488 Recruiting - Clinical trials for Peritoneal Carcinomatosis

Intraperitoneal Docetaxel in Combination With mFOLFOX6 for Gastric Cancer Patients With Peritoneal Carcinomatosis

Start date: November 1, 2020
Phase: Phase 1
Study type: Interventional

This is a single-center, open-label, non-randomized, uncontrolled Phase 1 study of intraperitoneal docetaxel in combination with systemic mFOLFOX6 for patients who have gastric cancer with gross peritoneal carcinomatosis (GC-PC).

NCT ID: NCT04572542 Recruiting - Clinical trials for Locally Advanced or Metastatic Gastric Adenocarcinoma

Camrelizumab Combined With Apatinib Mesylate Tablets and Nab-paclitaxel in the Second-line Treatment of Advanced Gastric Cancer

Start date: January 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

To evaluate the clinical efficacy and safety of camrelizumab combined with apatinib mesylate and nab-paclitaxel .