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390 active trials for Gastric Cancer

MAGNET (Magnetically Controlled Capsule for Assessment of Gastric Mucosa in Symptomatic Patients)

This pilot and feasibility study will be first US study to determine if a magnetically controlled capsule (MCC) can effectively visualize the anatomy of the stomach like a more traditional upper endoscopy (EGD). This study is designed to enroll participants who have a standard indication for an EGD and are also willing to get an MCC exam. The MCC is driven actively by a clinician unlike prior capsule endoscopes that move passively by gravity or peristalsis. Thus, a physician will be able to look more closely at areas of the stomach that might be concerning and might need further evaluation and/or treatment.

Start: January 2021

A Study of KF-0210 in Advanced Solid Tumors Patients

The purpose of this Phase I, Multi-Center, Open-Label Study is to evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and anti-tumor activity of KF-0210 in participants with advanced solid tumors. The study will be conducted in two parts: phase Ia, and phase Ib.

Start: January 2021

EndoVE endosCopic Treatment for Oesophageal and Gastric canceR

This project aims to establish the safety and efficacy of treating patients with inoperable oesophageal cancer or gastric cancer, using an endoscopic electroporation system (EndoVE) to facilitate direct chemotherapy tumour absorption.

Start: January 2021

Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

This is a first-in-human, open-label, non-randomized, 4-part Phase 1 trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda).

Start: December 2019

Pembrolizumab Plus Ramucirumab in Metastatic Gastric Cancer

Objective 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.

Start: March 2021

Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B), biopsy cohorts with monotherapy lead-in at the maximum tolerated dose (MTD) or maximum administered dose (MAD), followed by combination of anti-PD-1 [PF-06801591] (Part 1C) followed by dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 2 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.

Start: November 2019

Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer

RESONANCE-II trial is a prospective, multicenter, randomized, controlled phase III study which will enroll 524 patients in total. Patients with eligibility will be registered, pre-enrolled and receive three cycles of SOX. Then, tumor response evaluation will be carried out. Those who achieve stable disease or progressive disease will be excluded. Patients achieving complete response or partial response will be enrolled and assigned into either group A for another three cycles of SOX (six cycles in total) followed by D2 surgery and group B for D2 surgery (three cycles in total). The primary endpoint is the rate of pathological complete response and the secondary endpoints are R0 resection rate, three-year disease-free survival, five-year overall survival and safety.

Start: January 2021

Multicentric Randomised Trial for Resectable Gastric Cancer

The CRITICS-II trial aims to identify the optimal preoperative regimen in resectable gastric cancer by comparing three investigational treatment arms: chemotherapy vs. chemotherapy and subsequent chemoradiotherapy vs. chemoradiotherapy. The rationale behind this trial design is based on the following concepts: Preoperative treatment is associated with better patient compliance than postoperative regimens Preoperative treatment increases the likelihood of disease downsizing/downstaging and radical R0 resections Preoperative paclitaxel/carboplatin-based concurrent chemoradiotherapy and DOC chemotherapy are effective, feasible and safe regimens

Start: December 2017

Metabonomics Study of Chronic Gastritis and Gastric Carcinoma

The pathogenetic mechanisms of chronic gastritis and gastric carcinoma are different. Whether metabonomics play a role in the development of chronic gastritis and gastric cancer is still a question. So the investigators want to clarify this question by this subject.

Start: November 2020

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants With Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

The purpose of this study is to determine the Objective Response Rate (ORR) of zolbetuzimab as a single agent as assessed by an independent central reader. This study will also assess the ORR and Progression Free Survival (PFS) of zolbetuximab in combination with mFOLFOX6 and in combination with pembrolizumab, assess the safety and tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and immunomodulatory effects of zolbetuximab as a single agent and in combination with mFOLFOX6 and in combination with pembrolizumab. This study will also evaluate the pharmacokinetics (PK) of zolbetuximab, oxaliplatin, fluorouracil (5-FU), and pembrolizumab, evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 and in combination with pembrolizumab based on both investigator and independent central reader assessment, assess Overall Survival (OS) of zolbetuximab as a single agent and in combination with pembrolizumab.

Start: June 2018

Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer

A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of KY1044 as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate.

Start: January 2019

Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis

Background: 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.

Start: September 2020

Combination of TATE and PD-1 Inhibitor in Liver Cancer

This is a single center, open-label phase IIA study that investigates the preliminary efficacy of Trans-arterial Tirapazamine Embolization (TATE) treatment of liver cancer followed by a PD-1 checkpoint inhibitor (either nivolumab or pembrolizumab). Patients with four types of cancers will be enrolled, hepatocellular carcinoma (HCC), metastatic colorectal cancer (mCRC), metastatic gastric cancer and advanced non-small cell lung cancer. All enrolled patients need to have liver lesions.

Start: July 2017

Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

This is a prospective, multi-center, randomized controlled trial to compare Billroth II reconstruction versus conventional Roux-en-Y reconstruction versus long limb Roux-en-Y reconstruction for glycemic control in patients with concurrent type 2 diabetes and gastric cancer.

Start: December 2020

The Conversion Therapy of Chemotherapy Plus Camrelizumab in Metastatic Gastric Cancer

Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric cancer patients diagnosed for the first time in China have a higher proportion of advanced stages and a higher postoperative metastasis rate.Studies have shown that patients with good pathological response after preoperative neoadjuvant therapy (such as tumor regression grade, TRG0 or 1) have a better prognosis.The purpose of this study is to treat patients with advanced gastric cancer who are difficult to perform R0 surgery with chemotherapy combined with immunotherapy. At the same time as the primary cancerous lesions are reduced, the distant metastatic lesions are effectively controlled in order to perform R0 surgery and to improve the survival rate of patients with advanced gastric cancer.

Start: December 2020

EGFR Monoclonal Antibody for Advanced Gastric Cancer

This study is intended to evaluate efficacy and safety of EGFR monoclonal antibody (Cetuximab/Nimotuzumab) in combination with a chemotherapy in gastric cancer patients with EGFR amplification.

Start: July 2019

Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric or Gastro-esophageal Junction Cancer (APICAL-GE)

This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric or gastro-oesophageal junction cancer as first-line treatment.

Start: February 2020

COVID - 19 and Advanced Gastro-intestinal Cancer Treatment

A multicenter Italian retrospective study on COVID-19 pandemic condition and advanced Gastro - Intestinal Cancer. Are in Italy increased the new diagnosis of GI cancer in advanced stage in the 2020 compared with 2019, as a consequence of COVID-19?

Start: January 2021

KeyLargo: Pembrolizumab + Oxaliplatin + Capecitabine in Gastric Cancer

This study will be conducted in two stages: 1) safety validation and 2) dose expansion Safety Validation Cohort: The first portion of the study will preliminarily establish the tolerability of the combination of pembrolizumab, oxaliplatin and capecitabine. Five (5) subjects will be enrolled and their safety data after 21 days of treatment will be reviewed before additional subjects are enrolled. Subjects on this portion of the study will only be enrolled at the Duke Cancer Institute. Dose Expansion Cohort: The second portion of the study (ie. phase II) will enroll 30 subjects. In the dose expansion cohort, the first cycle will be modified to allow one week of pembrolizumab monotherapy before starting capecitabine and oxaliplatin (XELOX) chemotherapy, which will allow analysis of biomarkers related to pembrolizumab. Subjects on this portion of the study will be enrolled at the Duke Cancer institute and select external collaborating institutions. The primary objective of this trial is to describe the progression free survival (PFS) associated with the combination of pembrolizumab, oxaliplatin and capecitabine (pembrolizumab +XELOX) in all patients with previously untreated metastatic esophagogastric adenocarcinoma.

Start: January 2018

Neoadjuvant Chemotherapy Plus Surgery Versus Surgery First For Elderly Gastric Cancer Patients

The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.

Start: January 2021