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Stomach Neoplasm clinical trials

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NCT ID: NCT05645198 Recruiting - Stomach Neoplasm Clinical Trials

The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy

OOZFIX
Start date: October 26, 2022
Phase: Phase 4
Study type: Interventional

Although the technique of radical gastrectomy had been advanced, postoperative complication can occur in 13~25% of patient after radical gastrectomy. Pancreatic fistula and postoperative bleeding was reported as 2~30% and 1~2%, respectively. These complications often result fatal clinical course, so localized fibrin agent has been widely used at postoperative surgical bed after radical gastrectomy. Recently, natural origin polysaccharide-based carboxymetyl starch was approved as localized coagulative, no well-designed report was adressed in gastric cancer surgery field. This agent can formate physical barrier after application, thus can prevent microbleeding or pancreatic fistula after gastrectomy. THIS study is single-center, non-inferiority, open-label randomized trial that evaluates the effect of carboxymetyl starch (Oozfix) on preventing postoperative complication after gastrectomy.

NCT ID: NCT05640609 Recruiting - Stomach Neoplasm Clinical Trials

Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer

Start date: March 10, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. This is a one-arm, open and prospective phase II clinical study. Recruit patients who have been diagnosed with advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction and have not received systematic treatment.

NCT ID: NCT05543863 Recruiting - Clinical trials for Cardiovascular Diseases

Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

Start date: August 20, 2022
Phase:
Study type: Observational [Patient Registry]

This study is aimed to investigate the changes in pharmacokinetics and efficacy of antiplatelet agents before and after distal gastrectomy in gastric cancer patients taking oral antiplatelet agents for primary or secondary treatment for cardiovascular disease and to evaluate its impact on the occurrence of postoperative bleeding complications and thromboembolic events.

NCT ID: NCT05184803 Recruiting - Stomach Neoplasm Clinical Trials

A Phase 2 Study of Neoadjuvant Docetaxel, Oxaliplatin, S-1 in Patients With Unresectable Locally Advanced or Distant Metastasis Limited to Lymph Node Gastric Cancer

Start date: March 23, 2022
Phase: Phase 2
Study type: Interventional

Gastric cancer is the fifth most common carcinoma in the world, and cancer-related deaths rank third. It is one of the main causes of death from cancer in Korea. The cure method for gastric cancer is radical resection, but in most patients, radical resection is impossible due to local infiltration or peripheral organ or distant metastasis. Many assisted chemotherapy has been studied to improve survival rate, and in East Asia, assisted chemotherapy after complete D2 resection is the standard treatment. In the West, on the other hand, preoperative chemotherapy and postoperative assisted chemotherapy are currently standard treatments. However, due to the limited effect of adjuvant chemotherapy, it has been reported that better clinical course can be improved by increasing anticancer intensity. In this context, a large number of prior chemotherapy have been attempted, and prior chemotherapy has several potential effects as follows. (1) Improvement of R0 resection rate due to reduced primary cancer size, (2) early treatment for micro metastasis, (3) evaluation of treatment response rate in patients with measurable lesions, and (4) unnecessary laparotomy can be avoided in patients with biologically aggressive diseases. Based on the efficacy of chemotherapy in the combination of docetaxel, fluoropyrimidine, and platinum in metastatic gastric cancer, the investigators conducted a preceding auxiliary anti-cancer clinical trial of docetaxel, capecitabine and cisplatin in advanced gastric cancer patients who could not be completely resected by surgery. DXP was performed 4-6 cycles before surgery with the recommended dose in phase 1-2. In a total of 49 patients, R0 resection was performed in 31 (63%), and among patients, R0 resection was improved in cases where resection was not possible due to local infiltration (71%) and in cases where para-aortic node metastasis was performed (73%). We have reported that docetaxel, oxaliplatin, and S-1 chemotherapy (DOS) as preoperative adjuvant therapy can be safely administered in combination with D2 gastrectomy and postoperative adjuvant therapy S-1 in potentially resectable local progressive gastric cancer patients. R0 resection was achieved in 97.6% of patients, and pathological complete remission was observed in 19.5%. Based on this, a phase 3 PRODIGY study was performed to evaluate the benefit of S-1 (CSC group) as a preoperative prior chemotherapy compared to S-1 (SC group) as a postoperative adjuvant therapy in gastric cancer of cT2/3N+ or cT4Nany stage, and 0.75% of the CSC group was administered HR. In the patient group undergoing surgery, the R0 resection rate was 95% in the CSC group and 84% in the SC group. In the CSC group, the pathological complete remission rate was 10.4%. Based on these results, a clinical trial of DOS as a preoperative chemotherapy was planned for progressive gastric cancer that could not be resected due to local progression or metastasis limited to remote lymph nodes. Primary goal: Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial. Secondary objective: safety evaluation, overall survival period, progression-free survival period, pathological complete remission rate, and investigation of biological markers.

NCT ID: NCT05180864 Recruiting - Stomach Neoplasm Clinical Trials

Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer

OMEGA-2
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Curative therapy for gastric cancer usually consists of perioperative chemotherapy and a radical (R0) gastrectomy. A radical resection includes a modified D2 lymphadenectomy, and, generally, a complete omentectomy, to ensure the removal of omental metastatic lymph nodes and tumor deposits. The omentum has some essential functions within the peritoneal cavity. The omentum functions as regulator of regional immune responses to prevent infections and, additionally, it prevents adhesions that can lead to small bowel obstruction. Omentectomy is associated with increased incidence of early and late postoperative complications such as abdominal abscess, ileus, and wound infections in various types of surgery. There is little evidence regarding survival benefit of routine complete omentectomy during gastrectomy. The investigators hypothesize that omitting a complete omentectomy (and instead preserve the greater omentum distal of the gastroepiploic arcade) during gastrectomy for cancer does not negatively impact survival. OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Adult patients (>18 years) with primary resectable gastric cancer, clinical stage T2-4a N0-3 M0 or cT1N+ scheduled for open or minimally invasive (sub)total gastrectomy are included. The primary study objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of three-year overall survival.

NCT ID: NCT05007912 Recruiting - Stomach Neoplasm Clinical Trials

Prospective Observational Study Comparing the Use of Circular (Orvil) and Linear Stapler for Intracorporeal Esophagojejunostomy

Start date: June 21, 2021
Phase:
Study type: Observational

Prospective observational study comparing the use of circular (Orvil) and linear stapler for intracorporeal esophagojejunostomy. Patients with adenocaricinoma involving the esophagogastric junction or the gastric cardia are observed. The two methods of esophagojejunostomy are compared.

NCT ID: NCT04913662 Recruiting - Stomach Neoplasm Clinical Trials

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel in Gastric Cancer Patients With Peritoneal Metastasis

Start date: April 26, 2021
Phase: Phase 1
Study type: Interventional

This is a phase I trial investigating the safety of pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel combined with intravenous FOLFOX therapy for gastric cancer patients with peritoneal metastasis.

NCT ID: NCT04893252 Recruiting - Stomach Neoplasm Clinical Trials

Vactosertib and Durvalumab in Gastric Cancer

Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

This trial will test the efficacy and safety of durvalumab in combination with vactosertib in patients with metastatic gastric cancers who failed ≥ 2 lines of chemotherapy

NCT ID: NCT04889859 Completed - Clinical trials for Diabetes Mellitus, Type 2

Impact of Biliopancreatic Limb Length on Diabetes Following Distal Gastrectomy

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

This is a prospective, randomized controlled trial to investigate the impact of a long biliopancreatic limb of Roux-en-Y reconstruction on diabetes control in patients with concurrent type 2 diabetes and gastric cancer

NCT ID: NCT04744649 Recruiting - Gastric Cancer Clinical Trials

Neoadjuvant Immunotherapy and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial

NICE
Start date: March 12, 2021
Phase: Phase 2
Study type: Interventional

For locally advanced esophagogastric junction and gastric cancer (cT3-4aNxM0 or cT2N+M0), neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early before local therapy has begun, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate. JS001 in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate safety and efficacy of JS001 in combination with perioperative chemotherapy in locally advanced esophagogastric junction and gastric cancer. Differences in gut microbiome and tumor immune microenvironment were detected to screen people who were more sensitive to immunotherapy.