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Advanced Gastric Carcinoma clinical trials

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NCT ID: NCT05270824 Not yet recruiting - Clinical trials for Advanced Gastric Carcinoma

Study Evaluating Neoadjuvant Immunotherapy Increasing CD8+ Cell Infiltration in Advance Gastric Adenocarcinoma

Start date: March 1, 2022
Phase: Phase 3
Study type: Interventional

Focusing on the clinical question of whether patients with advanced gastric cancer can benefit from immunotherapy, this project intends to detect the degree of CD8+ tumor-infiltrating lymphocyte infiltration in patients with advanced gastric cancer before and after receiving neoadjuvant combined immunotherapy and neoadjuvant therapy alone. To explore the evolving nature of tumor immune response before and after neoadjuvant therapy for gastric cancer, and quantitatively present it through chemical immunohistochemical techniques to achieve a more accurate diagnosis and treatment and improve the long-term efficacy of patients.

NCT ID: NCT05226169 Recruiting - Clinical trials for Advanced Gastric Carcinoma

Efficacy and Safety oF FErric CarboxymalTose in Patients With Advanced Gastric Cancer(EFFECT-AGC)

Start date: April 29, 2022
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy and safety of IV FCM(ferric carboxymaltose) in patients with AGC receiving palliative chemotherapy. This study will also evaluate the effect of IV FCM on the treatment outcomes of palliative chemotherapy in patients with gastric cancer receiving fluoropyrimidine and platinum-based regimen in the same 1st-line palliative setting.

NCT ID: NCT05221775 Recruiting - Clinical trials for Advanced Gastric Carcinoma

Safety of XELOX Combined With GLS-010 and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients

Start date: November 1, 2021
Phase: Phase 1
Study type: Interventional

This is a single center, prospective, open label phase I study evaluating the safety and tolerance of standard first-line chemotherapy XELOX regimen combined with GLS-010 (anti-PD-1 antibody) and different doses of 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. 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 GLS-010 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 GLS-010 (240 mg, intravenous infusion, every 3 weeks) plus Lenvatinib whose dose is based on the '3 + 3' dose climbing mode (12mg, 16mg and 20mg respectively, orally once a day). Safety will be evaluated by AE and laboratory tests. Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.

NCT ID: NCT04948125 Recruiting - Clinical trials for Advanced Gastric Carcinoma

Camrelizumab Combined With Apatinib for Advanced Gastric or Esophagogastric Adenocarcinoma

Start date: April 28, 2021
Phase: Phase 2
Study type: Interventional

This study is a phase II study, to evaluate the effectiveness and safety of Camrelizumab combined with apatinib for advanced gastric or esophagogastric adenocarcinoma progressed after immune checkpoint inhibitors.

NCT ID: NCT04808791 Not yet recruiting - Clinical trials for Gastroesophageal Junction Adenocarcinoma

A Phase II Trial of iTTo in Advanced Gastric and GEJ Adenocarcinoma

Start date: August 31, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and feasibility of Irinotecan, Trifluridine/Tipiracil (TAS-102) and Oxaliplatin (iTTo) for treatment naïve advanced gastric or gastroesophageal junction adenocarcinoma.

NCT ID: NCT04739202 Recruiting - Clinical trials for Gastric Adenocarcinoma

Personalized Targeted IMMUNOtherapy-based Regimens in Recurrent GASTric Adenocarcinoma (IMMUNOGAST)

IMMUNOGAST
Start date: March 19, 2021
Phase: Phase 2
Study type: Interventional

For patients with advanced/metastatic gastric adenocarcinomas in progression after a first line chemotherapy comprising platinum and fluoropyrimidine, the reported second line treatments are : 1) paclitaxel combined with ramucirumab (overall response rate (ORR) = 25%; median progression free survival (PFS) = 2.9 months; median overall survival (OS)= 5.9 months), or paclitaxel alone (ORR = 14%, median PFS = 2.9 months; median OS= 5.9 months); 2) docetaxel (ORR = 7%, median OS = 5.2 months) or 3) irinotecan (ORR = 0%, median OS= 4.0 months). These numbers demonstrate the poor prognosis of this disease, and the unmet medical need for innovative therapeutic strategies. Cancer Genome Atlas (TCGA) mapped a genomic landscape of gastric adenocarcinomas, and identified 4 sub-types: - Tumor positive for Epstein-Barr virus (EBV) (8%), which display recurrent PIK3CA mutations, extreme DNA hypermethylation, and amplification of JAK2, ErbB2, PD-L1 and PD-L2; - Microsatellite instable tumors (MSI-high) (22%), which show elevated mutation rates, including mutations of genes encoding targetable oncogenic signaling proteins (PIK3CA, ErbB2, ErbB3, and EGFR); - Genomically stable tumors (20%), which are enriched for the diffuse histological variant and mutations of RHOA or fusions involving RHO-family GTPase-activating proteins; - Tumors with chromosomal instability (50%), which show marked aneuploidy and focal amplification of receptor tyrosine kinases and VEGFA. Most of diffuse-type gastric adenocarcinomas were classified in genomically stable tumors. This subgroup of cancers, accounting for about 20 to 30% of gastric adenocarcinomas, is associated with particularly poor prognosis and resistance to chemotherapy. A proteomic landscape of diffuse-type gastric adenocarcinomas was recently reported. Pembrolizumab, an anti-PDL1 drug granted with an accelerated approval by FDA in September 2017, exhibited promising activity in gastric adenocarcinoma patients previously treated with 1 or 2 lines of chemotherapy (ORR=11.6%, median PFS = 2.0 months, median OS= 5.6 months), especially in those with PDL1 positive tumors (ORR=22.7%). The tumor response was particularly high in patients with MSI-high tumor (ORR=57.1%). However the preliminary outcomes of the phase III KEYNOTE-061 trial (NCT02370498) recently released in the press suggest that pembrolizumab was not superior to paclitaxel in 592 patients with advanced gastric or gastroesophageal junction adenocarcinoma whose disease progressed after first-line treatment with platinum and fluoropyrimidine doublet therapy (the hazard ratio (HR) for OS was 0.82 (95% confidence interval = 0.66-1.03; one sided P = .042) (http://www.ascopost.com/News/58377). These outcomes suggest that, although being very promising, immunotherapy should be combined to other agents for being fully effective in gastric adenocarcinomas patients. We propose a strategy based on molecular features to select the drugs that will be associated with atezolizumab, an anti-PDL1 drug, in patients with pre-treated advanced gastric adenocarcinomas: - Patients with tumors positive for EBV or microsatellite instable tumors (30%) will be treated with atezolizumab and ipatasertib. - Patients with genomically stable tumors (20%) will be treated with atezolizumab combined with bevacizumab. - Patients with tumors with chromosomal instability (50%) will be treated with atezolizumab combined with bevacizumab. Expected outcomes: IMMUNOGAST trial will provide data about the clinical feasibility of biomolecular characterization of gastric adenocarcinomas for routine treatment adjustment. Moreover it should generate information about the relevance of adjusting combined immunotherapies based on molecular subtypes, in terms of clinical efficacy. Finally, translational research project outcomes should provide important data about relationships between efficacy and tumor immune gene spatial expression, along with tumor and circulating mutational burden. These outcomes may help identify the best candidates for tested combinations in the future.

NCT ID: NCT04718402 Terminated - Clinical trials for Advanced Gastric Carcinoma

A Study of Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Advanced Gastric Carcinoma

Start date: March 30, 2021
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, single-arm, phase Ib study to evaluate the safety and efficacy of Mitoxantrone Hydrochloride Liposome in subjects with advanced gastric carcinoma.

NCT ID: NCT04704661 Recruiting - Clinical trials for Advanced Malignant Solid Neoplasm

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Patients With Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Start date: August 9, 2021
Phase: Phase 1
Study type: Interventional

The dose escalation phase of this trial identifies the best dose and safety of ceralasertib (AZD6738) when given in combination with trastuzumab deruxtecan (DS-8201a) in treating patients with solid tumors that have a change (mutation) in the HER2 gene or protein and have spread to other places in the body (advanced). The dose expansion phase (phase Ib) of this trial compares how colorectal and gastroesophageal cancers with HER2 mutation respond to treatment with a combination of ceralasertib and trastuzumab deruxtecan versus trastuzumab deruxtecan alone. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Ceralasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT04535401 Active, not recruiting - Clinical trials for Stage IV Colorectal Cancer AJCC v8

Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines

Start date: August 13, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial investigates the best dose, possible benefits and/or side effects of BAY 1895344 in combination with FOLFIRI in treating patients with stomach or intestinal cancer that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan, fluorouracil, and leucovorin, (called FOLFIRI in short) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BAY 1895344 in combination with FOLFIRI may help shrink advanced or metastatic stomach and/or intestinal cancer.

NCT ID: NCT04491942 Active, not recruiting - Clinical trials for Advanced Malignant Solid Neoplasm

Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer

Start date: August 25, 2021
Phase: Phase 1
Study type: Interventional

This 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.