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Stomach Neoplasm clinical trials

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NCT ID: NCT06121700 Recruiting - Metastatic Cancer Clinical Trials

Radiotherapy + Chemoimmunotherapy Followed by Surgery in Patients With Limited Metastatic Gastric or GEJ Cancer

Miracle-G
Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of radiotherapy combined with chemotherapy and anti-PD-1 immunotherapy followed by surgery for the primary and metastatic lesions in patients with limited metastatic gastric or gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies will improve the survival of this group of patients. 2) If the multimodal treatment which includes anti-PD-1 immunotherapy and local therapies can be performed safely in this group of patients. Participants will receive short course hypofractionated radiotherapy (HFRT) for the primary lesion, HFRT or stereotactic body radiotherapy (SBRT) for metastatic lesions, combined with systemic chemotherapy and anti-PD-1 immunotherapy. For patients with HER2-positive cancer (defined as IHC 3+ or 2+/ISH+), trastuzumab is used along with chemotherapy and anti-PD-1 antibody. Then, surgical resections of primary and metastatic lesions are performed as much as possible. For patients who need a widely invasive surgical approach or are inoperable, local ablative therapies such as radiofrequency ablation (RFA) and microwave ablation (MVA) can be alternatives. For patients undergoing surgical resections, postoperative treatment includes chemotherapy, which is determined by the researcher, and PD-1 antibody, which will be maintained until one year after surgery.

NCT ID: NCT06028737 Recruiting - Gastric Cancer Clinical Trials

Total Neoadjuvant Chemotherapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer

OCTASUR
Start date: August 25, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The main goal of this study is to investigate the histopathological regression rate in patients with locally advanced gastric and gastroesophageal adenocarcinoma without previous treatment who will be prospectively randomized into two groups to undergo one of two chemotherapy regimens, followed by surgery: 1. 8 cycles of Total Neoadjuvant ChemoTherapy (TNT) with 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT) followed by surgery. 2. 4 cycles of Neoadjuvant FLOT chemotherapy scheme preoperatively and 4 adjuvant FLOT cycles postoperatively.

NCT ID: NCT05980416 Recruiting - Neoplasms Clinical Trials

Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2

Start date: August 10, 2023
Phase: Phase 1
Study type: Interventional

This study is an open-label, international, multi-center, Phase 1 study in adult patients with solid tumors likely to express CLDN18.2.

NCT ID: NCT05714878 Recruiting - Stomach Neoplasm Clinical Trials

Multimodal Prehabilitation for Resectable Gastric Cancer

Start date: March 22, 2023
Phase: N/A
Study type: Interventional

Surgical resection is the mainstay for gastric cancer. Surgical stress response, like insulin resistance and catabolism, is inevitable and is a risk factor for postoperative outcome. To cope with this stress, the enhanced recovery protocol has been proposed and successfully implemented in clinical practice. Recently, prehabilitation have attracted increasingly attention, which is the preoperative part of enhanced recovery pathway. Prehabtilitation are bundles of evidenced elements in order to improve patient's functional capacity. Patients with gastric cancer are usually suffered from nutritional risk, anxiety and frailty. In this trial, we investigate whether multimodal prehabilitation (exercise, nutrition and psychological support) could improve patient's functional status to better tolerate surgical trauma.

NCT ID: NCT05698992 Recruiting - Gastric Cancer Clinical Trials

Rehabilitation and Recovery for Persons With Esophageal or Gastric Cancer

Start date: February 27, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to develop and evaluate a model for systematic and evidence-based cancer rehabilitation for people with esophageal and gastric cancer to provide conditions for a better quality of life and fewer cancer-related symptoms.

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.