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Stomach Neoplasms clinical trials

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NCT ID: NCT06383793 Recruiting - Gastric Cancer Clinical Trials

Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy

Start date: April 1, 2024
Phase:
Study type: Observational

As of now, although the safety of π-shaped anastomosis and the overlap method has been separately discussed in different contexts, there have been few studies considering a direct comparison of the results of these two methods. This article aims to explore the differences in the short-term therapeutic effects, surgical effectiveness, and safety between laparoscopic total gastrectomy with esophagogastrostomy using the overlap method and the π-shaped method. The goal is to provide new reference points for surgeons in the clinical decision-making process regarding the choice of anastomotic techniques during totally laparoscopic total gastrectomy.

NCT ID: NCT06383559 Recruiting - Gastric Cancer Clinical Trials

Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients

Start date: December 1, 2023
Phase: Phase 2
Study type: Interventional

This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (>=60kg, 200 mg; <60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.

NCT ID: NCT06371586 Recruiting - Gastric Cancer Clinical Trials

Neo-Sequence 2:NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC

Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer.

NCT ID: NCT06370143 Recruiting - Gastric Cancer Clinical Trials

A Study Collecting Health Information to Understand and Prevent Gastric Cancer

Start date: April 11, 2024
Phase:
Study type: Observational

The purpose of this study is to create a registry of participants with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled.

NCT ID: NCT06365008 Recruiting - Clinical trials for Unresectable/Metastatic Gastric Cancer

Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer

Start date: April 8, 2024
Phase: Phase 2
Study type: Interventional

The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. However, there are no standard recommendations for subsequent treatment after progression on first-line therapy. Here, the investigators conduct this open-label, monocenter, single arm phase II study to evaluate whether sintilimab in combination with irinotecan, leucovorin folinate and fluorouracil can be the salvage therapy for patients diagnosed with unresectable or metastatic gastric cancer progression on first-line therapy. Patients participated in this study will receive sintilimab 3mg/kg for patients with body weight<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. The primary endpoint is progression-free survival (PFS). The investigators estimated that 40 patients were necessary. Secondary endpoints include overall survival, objective response rate, disease control rate and safety for unresectable or metastatic gastric cancer.

NCT ID: NCT06362070 Recruiting - Gastric Cancer Clinical Trials

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

Start date: January 31, 2024
Phase: N/A
Study type: Interventional

The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms: - DaVinci; - Hugo; - Versius. This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one. The questions it aims to answer are: - Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable? - Are there any differences between the three platforms related to the learning curve for surgeons? Participants will be enrolled, after obtaining informed consent, in one of the following cohorts: 1. surgery with the daVinci platform; 2. surgery with the Hugo platform; 3. surgery with the Versius platform.

NCT ID: NCT06354036 Recruiting - Gastric Cancer Clinical Trials

Transhiatal Tunnel Valvuloplasty for Reconstruction Following the Laparoscopic Proximal Gastrectomy

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Patients who meet the inclusion criteria will undergo laparoscopic proximal gastric cancer radical surgery, and esophagogastric anastomosis will be performed using the ThTV method. Review the surgical video and record the time for making the extracorporeal muscle flap, tunnel passage time, and anastomosis time. The production time of the muscle flap is based on the electric knife incision of the muscle flap as the starting point, and successfully penetrating the muscle flap as the endpoint. The tunnel passes through time, pulling the residual end of the esophagus, and starting to pass through the gastric muscle flap tunnel as the time starting point. The complete placement of the gastric tube into the lower mediastinum is used as the time endpoint. The anastomosis time is calculated from the first needle of suturing the residual stomach and the posterior wall of the esophagus until the end of the plasma flap suturing. Record perioperative indicators such as surgical time, bleeding volume, and postoperative hospital stay. The definition of anastomotic stenosis is that in gastroscopy, those who cannot pass through the anastomotic site with ultra-fine endoscopy are judged as anastomotic stenosis. Postoperative pathology was performed using the 8th edition AJCC staging. Follow up every three months after surgery, including blood tests, liver and kidney function, and tumor markers. According to the situation, choose gastroscopy, upper gastrointestinal imaging, and chest abdominal pelvic enhanced CT. Evaluate postoperative reflux symptoms such as heartburn and sternal pain using the Visick grading system. Gastroscopy Los Angeles grading was used to evaluate postoperative reflux esophagitis.

NCT ID: NCT06346392 Recruiting - Gastric Cancer Clinical Trials

AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2

Start date: March 4, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.

NCT ID: NCT06342427 Recruiting - Gastric Cancer Clinical Trials

Stomach Cancer Exosome-based Detection

DESTINEX
Start date: March 15, 2023
Phase:
Study type: Observational

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.

NCT ID: NCT06341595 Recruiting - Gastric Cancer Clinical Trials

Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM

Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy. Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher.