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38 active trials for Stomach Neoplasms

CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors

Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.

Start: February 2021

Hereditary Gastric Cancer Syndromes: An Integrated Genomic and Clinicopathologic Study of the Predisposition to Gastric Cancer

Background: Gastric cancers are cancers of the stomach. Hereditary ones are passed from parent to child. Researchers want to gather data about hereditary gastric cancers. They want to learn about changes these cause in the body and about the genes involved. Objective: -To gather data about hereditary gastric cancer. Eligibility: People at least 2 years old with personal or family history with a hereditary gastric cancer. People at least 2 years old with gene changes that lead to such cancer or a lesion that may be hereditary. Design: Participants will be screened in a separate protocol. Participants will have: Physical exam Medical history Blood tests Scans Photos of skin lesions and other findings Gynecology consultation for women Cheek swab (some participants) For some participants, their relatives will be asked to join the study. Some participants will be asked to allow the study to get stored tissue samples for relatives who have died. Some samples will be sent to outside labs. All personal data will be protected. Samples will be destroyed when the study ends. Participants will get the results of genetic testing. Participants who cannot come to the NIH clinic may just give a cheek swab and have genetic testing done. Some participants will be contacted for more testing.

Start: January 2017

Acupuncture for QoL and Symptoms in Gastric Cancer During Adjuvant Chemotherapy

In the investigator's pilot study(NCT 03753399), a trend of improvement of quality of life, as well as release of symptoms, in gastric patients in acupuncture groups was indicated. This study will evaluate the efficacy of acupuncture on QoL in gastric cancer patients undergoing postoperative adjuvant chemotherapy with more samples. Enrolled participates will randomly receive high-dose acupuncture, low-dose acupuncture or non-acupuncture during the first 3 cycles of adjuvant chemotherapy after resection.

Start: May 2020

Comparing the Efficacy and Safety of Intra-peritoneal Infusion of Catumaxomab and Treatment of Investigator Choice in Patients With Advanced Gastric Carcinoma With Peritoneal Metastasis

A total of 297 subjects are estimated to enroll in the study, with 15 eligible subjects enrolled in the 1st stage at most and 282 evaluable subjects in the 2nd stage. All subjects are adult patients with age over 18-year-old; they must be diagnosed with recurrent or metastatic gastric cancer with peritoneal metastasis at the time of enrollment; and failed at least prior two standard systemic anti-cancer therapies for recurrent or metastatic gastric cancer, before enrollment. In the first stage, pharmacokinetic characteristics and preliminary safety of catumaxomab will be explored in Asian patients with gastric cancer ; in Cohort A, the enrolled subjects will receive the first infusion at 10?g on day 1, which will be increased to 20 ?g, 50 ?g and 150 ?g on days 4, 8 and 11, respectively. 42 days are defined as a cycle. From the second cycle, catumaxomab will be changed to 20 ?g, 50 ?g, 150 ?g on days 1, 4, 8 respectively. In Cohort B, 28 days are defined as a cycle. It is estimated to enroll 6 subjects in each cohort first. In the second stage, approximate 282 subjects who meet the enrollment criteria are randomized into either catumaxomab infusion group (catumaxomab group) or treatment of investigator choice group (IC group), at a ratio of 2:1. Subjects at the first and second stages will continue the treatment until one of the following conditions occurs:1)Significant progression of tumor lesions, including but not limited to peritoneal metastases lesions and/or ascites; 2)Intolerable toxicity; 3)The investigator believes that patients need to withdraw from the study and receive other treatment;4)death;5)Withdrawal of informed consent.

Start: October 2020

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

Start: November 2018

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult Chinese participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

Start: November 2018

Prophylactic Surgery Plus HIPEC With CO2 in Patients Affected by Gastric Carcinoma.GOETH Study

This is a phase III randomized, multicenter study with two different arm: experimental: prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin comparator: standard surgery Adjuvant treatment after surgery is mandatory except for documented cases of non-eligibility in both arms. Patient will be randomized in a 1:1 ratio. Randomization will be performed during surgery if the total resection of tumor will be reached according to center and neoadjuvant chemotherapy as stratification variables.

Start: June 2020

FOLFIRINOX vs FLOT Chemotherapy for Resectable Gastric or Esophagogastric Junction Adenocarcinoma

Patients with resectable adenocarcinoma of the stomach or the esophagogastric junction (II-III type by Siewert) without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Docetaxel (FLOT), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX). Main objective of the study is median overall survival.

Start: January 2019

OLGA and OLGIM Stage System for Gastric Cancer

To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk according to Lauren's histologic classification in South Korea. Also attempted to estimate synergistic interaction among the several risk factors to help establish surveillance strategy.

Start: February 2006

Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer

This study aims to test the hypothesis that the diagnosis for histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status in gastric cancer is at least as reliable when performed on endoscopic biopsy specimens as on surgical resection specimens.

Start: April 2021

Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.

Start: January 2021

Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma

Background: Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States. The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis. Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease. Objectives: -To allow sample acquisition for use in the study of mesothelioma. Eligibility: All patients age greater than or equal to 2 years with malignant mesothelioma Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18 Design: Up to 1000 subjects will be enrolled. Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma. Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking. Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.

Start: September 2013

Phase II Study of Avelumab Plus Chemotherapy in the Peri-operative Treatment for Patients With Resectable Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC)

Phase II Study of Avelumab plus chemotherapy in the peri-operative treatment for patients with resectable Gastric cancer (GC) or Gastroesphageal Junction cancer (GEJC) The addition of Avelumab to the perioperative chemotherapy in GC and GEJC patients may increase pathological responses by a synergic effect activating the immune response. Conclusively, the survival of these patients would improve. The primary objective is to investigate whether the addition of avelumab to FLOT chemotherapy (docetaxel, oxaliplatin and fluorouracil/leucovorin) improves efficacy in terms of pathological complete response (pCR) rate, in GC and GEJC patients compared to the historical data of chemotherapy alone in the neoadjuvant setting.

Start: August 2019

Gastric Cancer Liver Metastasis Cohort of China

This multi-institutional retrospective cohort study aimed to describe and analyze the overall clinical characteristics, therapeutic status and prognosis pattern of gastric cancer liver metastasis (GCLM) in China.

Start: January 2010

Study on Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer

The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic spleen-preserving No. 10 lymph node dissection in a left-sided approach for advanced middle or upper third gastric cancer not invading greater curvature.

Start: January 2015

Quantitative Fluorescent Guided Robotic Surgery for Cancer of the Gastroesophageal Junction

The investigators also aim to use our previously described quantifying method (q-ICG), to evaluate changes in gastric perfusion, during resection of cancer in the gastroesophageal junction (GEJ) and if a change in the operative technique influences microvascular flow in the gastroesophageal (GE) anastomosis.

Start: June 2020

L-Gastrectomy With the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System

This study aims to evaluate the safety, efficacy, and feasibility of the Intelligent Navigation 4K UHD 3D Endoscopic Imaging System in patients with gastric cancer.

Start: October 2020

Comparison of the Efficiency Between Intraoperative and Postoperative Hyperthermic Intraperitoneal Chemotherapy With Docetaxel Combine Oxaliplatin in Patients With Advanced Gastric Cancer

Advanced gastric cancer has always been the focus and difficulty in the treatment of gastric cancer, and postoperative peritoneal recurrence is one of the key factors with poor prognosis. in recent years, hyperthermic intraperitoneal chemotherapy has been used in the treatment of advanced peritoneal metastases and achieved remarkable results. Existing studies have shown that postoperative hyperthermic intraperitoneal chemotherapy plays a certain role in reducing postoperative peritoneal recurrence of advanced gastric cancer. Our previous studies have shown that hyperthermic intraperitoneal chemotherapy adopted docetaxel combine oxaliplatin can also reduce the peritoneal recurrence of advanced gastric cancer. At present, there is a lack of comparison of the safety and efficacy of intraoperative and postoperative hyperthermic intraperitoneal chemotherapy. In this study, patients with advanced gastric cancer were selected by preoperative imaging, endoscopic ultrasonography and other examinations. The patients were randomly divided into group A: D1-2 radical gastrectomy plus hyperthermic intraperitoneal chemotherapy of docetaxel + oxaliplatin. Group B: D1-2 radical gastrectomy + postoperative hyperthermic intraperitoneal chemotherapy of docetaxel + oxaliplatin and group C: D1-2 radical radical gastrectomy .The three groups both proceed postoperative conventional adjuvant chemotherapy?SOX/XELOX?.The incidence of postoperative anastomotic leakage and other complications were collected, and the safety differences among the three groups were compared. The three-year overall survival (OS), disease-free survival (PFS), and disease-related mortality were evaluated and the long-term effects among the three groups were compared.

Start: January 2021

Methylation Analysis of Circulating Tumor DNA in Gastric Cancer

The primary purpose of this trial is to describe the profile of ctDNA methylation in gastric cancer. The second purpose is to demonstrate the correlation between the plasma ctDNA methylation status and the diagnosis and prognosis of patients with early and intermediate stage gastric cancer.

Start: October 2020

A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer

This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in the treatment of gastric or gastroesophageal junction adenocarcinoma with postoperative pathological stage IIIB and IIIC.

Start: September 2020