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Gastric Cancer clinical trials

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NCT ID: NCT05013775 Completed - Gastric Cancer Clinical Trials

The Diagnostic Value of Staging Laparoscopy and Computed Tomography Response Assessment in Patients With Gastric Adenocarcinoma

Start date: January 15, 2019
Phase:
Study type: Observational

SUMMARY Rationale: Diagnostic laparoscopy (DL) and response assessment after neoadjuvant chemotherapy with computed tomography (CT) are two diagnostic modalities used to assess metastatic spread in gastric cancer patients. It is still unclear in what proportion of patients clinically relevant metastases or other significant findings (e.g. contra-indications of surgery) are detected that impact on the treatment. Objective: To determine the clinical value of diagnostic laparoscopy and computed tomography response assessment after neoadjuvant chemotherapy in patients with gastric and esophagogastric junction adenocarcinoma. Study design: Multicentre retrospective cohort study. Study population: All Patients with gastric and gastro-oesophageal adenocarcinoma who underwent clinical staging and were discussed at multidisciplinary team meetings (MDT) between January 2016 and December 2018. Intervention (if applicable): Not applicable. Main study parameters/endpoints: The main study parameter is the proportion (%) of patients who do not proceed with treatment as planned after a DL and CT response assessment (i.e. the proportion of patients in which metastasized disease or other contra-indications for surgery is found). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is an observational study, no burden or risks are associated with participation.

NCT ID: NCT04973631 Completed - Gastric Cancer Clinical Trials

The Effects of Sex and Age Differences on Gastric Cancer : a Retrospective Study

Start date: May 2003
Phase:
Study type: Observational

Gastric cancer (GC) is more prevalent in males than in females. One of these differences could be the effect of sex hormones such as estrogens. However, few reports have been reported regarding sex and age differences of incidence and survival of GC. The aim of this study was to evaluate the effect of sex and age on the incidence and survival of GC. And we would like to further analyze single GC and synchronous multiple GC, EBV, etc.

NCT ID: NCT04929587 Completed - Gastric Cancer Clinical Trials

Analysis of Influencing Factors of Preoperative Frailty in Elderly Patients With Gastric Cancer Based on the Health Ecology Theory

Start date: January 1, 2021
Phase:
Study type: Observational

Frailty is common in patients with gastric cancer undergoing surgical treatment. Preoperative frailty can lead to many adverse outcomes in patients after surgery. This study aims to comprehensively and systematically analyze the influencing factors of preoperative frailty in patients with gastric cancer based on the health ecology theory , to change some critical variable factors in the future, improving the overall prognosis of patients.

NCT ID: NCT04901585 Completed - Gastric Cancer Clinical Trials

Enterotomy Closure and Minimally Invasive Gastrectomy

Start date: January 1, 2009
Phase:
Study type: Observational

All consecutive patients from January 2009 to december 2019 who underwent minimally invasive partial gastrectomy for gastric cancer at thirteen high volume institutions will be retrospective analysed to assess the better way to fashion a handsewn intracorporeal enterotomy closure after a stapled anastomosis.

NCT ID: NCT04834778 Completed - Gastric Cancer Clinical Trials

A Study of HC-5404-FU to Establish the Maximum Tolerated Dose (MTD)

Start date: June 8, 2021
Phase: Phase 1
Study type: Interventional

Study HC-404-FCP-2011 is a first in human, Phase 1a, multi-center, open-label study to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability of oral dosing of HC-5404-FU in a dose-escalating fashion. Up to 36 qualified subjects at 3 to 5 US sites, who have specific tumor types of renal cell carcinoma (RCC), gastric cancer (GC), metastatic breast cancer (MBC), small cell lung cancer (SCLC), and other solid tumors (e.g., non-small cell lung cancer, colorectal cancer, carcinoma of unknown primary) with the exception of rapidly progressing neoplasms (e.g., pancreatic cancer, glioblastoma, hepatocellular carcinoma) will receive HC-5404-FU. Every effort will be made to ensure approximately 50% of all subjects enrolled will be subjects with RCC and GC. The starting dose level is 25 mg twice daily (BID), escalating to 50, 100, and 200 mg BID as safety allows, following the Bayesian Optimal Interval (BOIN) design. The safety monitoring committee (SMC) will evaluate the DLTs and cumulative safety and PK data at the end of each cohort. Based on the SMC recommendations after a comprehensive review of PK and safety data for 200 mg BID dose, higher dose levels will be evaluated, starting with 400 mg BID. The dose will escalate to 600 mg and then 900 mg following the BOIN design starting with 1 subject at each escalated dose, until the MTD is reached or the sponsor or SMC declares the dose most appropriate for clinical development. This Phase 1a will be expanded into a Phase 1b/2a study through a protocol amendment and will then assess the dose and tumor type(s) selected in Phase 1a as the most appropriate for further clinical development. Subjects will be dosed until unacceptable toxicity, disease progression per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST), subject withdrawal, any other administrative reasons, or after 2 years of treatment, whichever occurs first. Efficacy will be assessed via Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1); computed tomography (CT) scans will be conducted every 6 weeks. Safety, including occurrence of dose-limiting toxicities (DLTs), pharmacokinetics (PK), and biomarker parameters will also be assessed.

NCT ID: NCT04834661 Completed - Colorectal Cancer Clinical Trials

Performing Laparoscopic Surgery for Colorectal and Gastric Cancer Outside the Primary Registered Medical Institution

Start date: October 20, 2021
Phase:
Study type: Observational

This study investigates the safety and feasibility of performing laparoscopic surgery for colorectal and gastric cancer inside versus outside the primary registered medical institution under multi-sites practice (MSP) policy. This is a single practitioner, retrospective comparative study. The endpoints are peri-operative outcomes, pathological results, and medical costs.

NCT ID: NCT04830618 Completed - Gastric Cancer Clinical Trials

Aberrant DNA Methylation to Predict Metachronous Gastric Neoplasms

Start date: September 11, 2012
Phase:
Study type: Observational

The study is a prospective cohort study to investigate whether aberrant DNA methylation can be useful for the prediction of metachronous recurrence after endoscopic resection of gastric neoplasms (dysplasia or cancer). From 2012 to 2017, 300 patients were prospectively enrolled after endoscopic resection (ER) of gastric dysplasia or early gastric cancer. All lesions were assessed by endoscopy and biopsy before ER. Endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) was performed for gastric dysplasia and early gastric cancers which met the absolute indication (differentiated adenocarcinoma, intramucosal cancer, lesions < 20 mm, and no endoscopic evidence of ulceration). All lesions were curatively resected; if non-curatively resected, the patients were not enrolled from the study. All subjects, who provided informed consent, were asked to complete a questionnaire under the supervision of a well-trained interviewer. The questionnaire included questions regarding demographic data (age, sex), socioeconomic data (smoking, alcohol, and education), their family history of GC in first-degree relatives, and history of H. pylori eradication therapy. Also, MOS methylation level at baseline was measured from noncancerous gastric mucosae at corpus. When H. pylori was positive by CLOtest or histology at baseline or during the follow-up, eradication therapy was done. To evaluate whether H. pylori was eradicated, 13C-urea breath testing was performed at least 4 weeks after completion of the eradication therapy. All study subjects were closely followed up since recurrent tumors at previous endoscopic resection sites can be easily detected on endoscopy with biopsy and treated during follow-up. Patients with local recurrence underwent further treatments, including repeated ESD, APC, and gastrectomy based on pathology, and patients who refused treatment received supportive care. All patients underwent endoscopy with biopsy within 6 months, then at 12 months after ESD to check for metachronous lesions or local recurrences. After 12 months, endoscopy with biopsy was performed annually. In case of EGCs, abdominal CT scan was performed in the first year and biennially thereafter to detect lymph node or distant metastases. The definition of the completion of the study protocol was 1) endoscopic and/or radiologic follow-up for more than 3 years, or 2) development of metachronous gastric neoplasm (primary outcome: gastric dysplasia or cancer) during the follow-up. Metachronous recurrence was defined as secondary dysplasia or cancers detected > 1 year after initial diagnosis.

NCT ID: NCT04800991 Completed - Gastric Cancer Clinical Trials

NuGa (Nutrition for Gastric Cancer Patients)

Start date: March 17, 2021
Phase: N/A
Study type: Interventional

The objective of this pilot study is to evaluate the feasibility and efficacy of Rhexium Onco Nutrition, HDT-202 for post-operative care in patients who have undergone gastrectomy.

NCT ID: NCT04791293 Completed - Gastric Cancer Clinical Trials

The Model for End-Stage Liver Disease Sodium (MELD-Na) Score in Non-cirrhotic Patients With Gastric Cancer

Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

Gastric cancer is the fifth most common cancer worldwide. Gastrectomy with lymphadenectomy is still the most effective treatment modality, depending on the stage and location. Despite many radiological, surgical and anesthetic innovations, serious complications such as anastomotic leakage, intra-abdominal abscesses, wound complications are seen secondary to gastrectomy. Many clinical studies have been conducted to prevent and predict these complications. The Model for End-Stage Liver Disease (MELD) score, in which bilirubin, international normalized ratio (INR) and serum creatinine values were used to determine surgical risks in patients scheduled for liver transplantation. Latter developed by adding serum sodium (Na) to the formula. The MELD-Na score is used to predict postoperative complications in non-cirrhotic patients because of its simple and easy calculation.Moreover, The Meld-Na score was later used to predict complications for surgical procedures other than liver surgery such as colorectal surgery. In this study, we aimed to investigate the importance of the Meld-Na score in predicting the perioperative and postoperative outcomes in patients with gastric cancer.

NCT ID: NCT04770623 Completed - Gastric Cancer Clinical Trials

Docetaxel and Irinotecan in Gastric Cancer

Start date: March 5, 2021
Phase: Phase 2
Study type: Interventional

To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The primary end point is response rate. Secondary end points are toxicity, PFS and OS.