FOLFOX6 Versus mFOLFIRINOX as First Line Chemotherapy in Metastatic Gastric Cancer or Esophagogastric...
Gastric Carcinoma Stage IVEsophagogastric Junction Adenocarcinoma Stage IVPatients with metastatic 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 . One half of the patients gets 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin (FOLFOX6), the others 5-Fluorouracil (5-FU), Leucovorin, Oxaliplatin and Irinotecan (mFOLFIRINOX). Main objective of the study is progression free survival.
Adjuvant Capecitabine Versus Observation Alone in Curatively Resected Stage IB Gastric Cancer((KCSG...
Gastric Cancermulti-center, prospective, randomized, open-label phase III
Oncological Benefits of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With...
Peritoneal CarcinomatosisGastric CancerStomach cancer is recognized as the third leading cause of death of cancer patients worldwide. Despite the radical treatment carried out, the progression of gastric cancer occurs in 30-40% of patients. The most common type of tumor progression of this localization is peritoneal carcinomatosis. When peritoneal carcinomatosis occurs, the median survival of patients does not exceed 3 months, the overall survival is no more than 6 months. Unfortunately, when peritoneal carcinomatosis occurs, palliative chemotherapy remains the only treatment option. The modern strategy for the prevention and treatment of peritoneal carcinomatosis is based on the concept of regional chemotherapy. The main methods of regional chemotherapy are hyperthermic intraperitoneal chemotherapy (HIPEC) and Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC). PIPAC is a new technology for delivering chemotherapy drugs to tumor nodes on the surface of the peritoneum and allows the cytostatic to be evenly distributed over the abdominal cavity, increasing the depth of its penetration into tumor nodes due to the properties of aerosol and gradients of intra-abdominal and interstitial pressure. The method has a number of advantages over the HIPEC method: a large penetration depth of drugs, low trauma, the possibility of repeated use. We offer PIPAC for patients with locally advanced gastric cancer and a high risk of developing peritoneal carcinomatosis in an adjuvant mode in addition to standard treatment to prevent the development of carcinomatosis.
Nanatinostat Plus Valganciclovir in Patients With Advanced EBV+ Solid Tumors, and in Combination...
Nasopharyngeal CarcinomaEBV-Related Gastric Carcinoma3 moreThis study will evaluate the safety efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive solid tumors and in combination with pembrolizumab in patients with recurrent/metastatic nasopharyngeal carcinoma
Lenvatinib With Taxane Drugs Treatment for Advanced Gastric Cancer
HER2-negative Advanced Gastric CancerThe goal of this clinical trial is to study the safety and efficacy of lenvatinib combined with single-agent taxanes therapy in patients with HER2-negative advanced gastric cancer that have failed at the standard first-line therapy.
Toripalimab Plus FLOT in Locally Advanced Gastric Cancer
ChemotherapyImmune Checkpoint Inhibitor1 moreNeoadjuvant therapy for locally advanced gastric cancer is still in the exploratory stage. With the emergence of immune checkpoint inhibitors, neoadjuvant chemoimmunotherapy is also in the exploratory stage in locally advanced gastric cancer. At present, chemotherapy combined with immunotherapy is usually a simple combination of chemotherapeutic drugs and immune drugs, without taking into account of the influenece of applied sequence. The purpose of this study is to explore whether the sequence of chemotherapy and immunotherapy influence the complete pathological response rate in locally advanced gastric cancer.
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin,...
Advanced Bile Duct CarcinomaAdvanced Breast Carcinoma32 moreThis phase I trial identifies the best dose, possible benefits and/or side effects of BAY 1895344 in combination with chemotherapy in treating patients with solid tumors or urothelial cancer that has spread to other places in the body (advanced). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cisplatin and gemcitabine are chemotherapy drugs that stop the growth of tumor cells by killing the cells. Combining BAY 1895344 with chemotherapy treatment (cisplatin, or cisplatin and gemcitabine) may be effective for the treatment of advanced solid tumors, including urothelial cancer.
Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction
Peristaltic DirectionRoux-en-Y Gastrointestinal Anastomosis1 moreThe aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.
Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal...
Gastric CancerPeritoneal CarcinomatosisBackground: Approximately 15% of gastric adenocarcinoma patients presents with peritoneal carcinomatosis (PC) at the first encounter and is regarded as an unresectable and end-stage disease. The recommended treatment with palliative chemotherapy alone yields a poor clinical efficacy. Emerging evidences suggest the survival benefits of complete cytoreductive surgery (CRS) combined with normothermic intraperitoneal chemotherapy (N-IPEC) for gastric adenocarcinoma with limited PC. Objective: To evaluate the 6-month disease control rate (DCR) of complete CRS combined with N-IPEC and systemic chemotherapy for gastric adenocarcinoma with limited PC. Patients and methods: Patients having gastric adenocarcinoma with PCI ≤ 10 (Arm-A) or positive peritoneal wash cytology (CY1/P0) (Arm-B) will be enrolled. Patients with other distant metastasis, including brain, lung, liver, bone, will be excluded. All patients should undergo ≥ D2 gastrectomy and complete CRS followed by N-IPEC (paclitaxel] and systemic chemotherapy (high-dose fluorouracil and cisplatin [P-HDFL], or capecitabine and oxaliplatin [CAPOX]). N-IPEC (paclitaxel) will be administered in combination with systemic P-HDFL or CAPOX on day 1,8,15 or day 1,8 for each cycle, respectively. The disease status will be evaluated every 12 weeks based on the computed tomography scan, and the clinical evaluation (outpatient follow-up) will be performed every 2 weeks for whom receiving P-HDFL and every 3 weeks for whom receiving CAPOX. Patients will receive maximal 6 cycles N-IPEC with P-HDFL or 8 cycles N-IPEC with CAPOX. After N-IPEC is discontinued, P-HDFL or CAPOX will be continued alone until disease progression or death. The primary endpoint of this study is 6-month DCR, and the secondary endpoints include 6-month response rate for ascites, 1-year progression-free survival (PFS) and overall survival (OS), 3-year PFS and OS, and safety profiles. Based on Simon's minimax two-stage design, this trial will be carried out in two stages. In stage I, a total number of 13 (Arm-A) / 16 (Arm-B) patients is accrued. If there are ≤ 6 (Arm-A) / ≤ 14 (Arm-B) progression-free among these 13 (Arm-A) / 16 (Arm-B) patients, the study will be early stopped. Otherwise, additional 17 (Arm-A) / 2 (Arm-B) patients will be accrued in stage II, resulting in a total number sample size of 30 (Arm-A) / 18 (Arm-B). Expected result: A ≥ 75% (Arm-A) / ≥ 95% (Arm-B) 6-month DCR could be achieved for gastric adenocarcinoma patients with limited PC (Arm-A) / with CY1P0 (Arm-B) via this treatment strategy (complete CRS + N-IPEC + P-HDFL or CAPOX) -i.e., if there are ≥ 21 (Arm-A) / ≥ 16 (Arm-B) progression-free among the 30 (Arm-A) / 18 (Arm-B) enrolled patients, we will reject the null hypothesis and claim that the treatment is promising.
Pembrolizumab Plus Ramucirumab in Metastatic Gastric Cancer
Gastric CancerObjective 1) Primary Objective: To estimate preliminary overall response rate (ORR) of combination therapy of Ramucirumab and Pembrolizumab in patients with metastatic gastric or GEJ adenocarcinoma 2)Secondary Objectives: To assess secondary measures of clinical efficacy Best Overall Response Rate: BORR Disease Control Rate: DCR Progression-Free Survival:PFS Overall Survival: OS Duration of Overall Response: DOR & maximal tumor shrinkage Subjects : Patients with metastatic gastric or GEJ adenocarcinoma Study design(Dosage & Treatment) Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria. Ramucirumab 8mg/kg on q2W Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day) If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.