A Dose-Escalation and Dose-Expansion Study Evaluating the Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Gastric Cancer, Esophageal Cancer and Liver Cancer
This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA neoantigen tumor vaccine in the treatment of advanced gastric cancer, esophageal cancer, and liver cancer, including two phases: dose escalation and dose expansion. To evaluate the safety and tolerability of neoantigen tumor vaccine in subjects with advanced gastric cancer, esophageal cancer and liver cancer by conducting dose escalation trial in subjects diagnosed with advanced gastric cancer, esophageal cancer and liver cancer, and preliminarily evaluate the efficacy of neoantigen tumor vaccine in subjects with advanced gastric cancer, esophageal cancer and liver cancer. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment is performed in combination with PD-1/L1 to further evaluate the efficacy and safety profile of neoantigen tumor vaccine at a specific dose. Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determined whether to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors from Week 8 to Week 12. The dose escalation phase follows standard 3+3 design. 12-18 subjects are expected to be enrolled at 3 given dose level. The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1/L1 drugs are used in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine, with about 18 subjects. The usage and dosage of PD-1/L1 should aligned with the package insert.
NCT05192460 — Gastric Cancer
Status: Recruiting
http://inclinicaltrials.com/gastric-cancer/NCT05192460/
A Phase III, Single Center Randomized Controlled Trial of Thoracic Surgery Combined With Intrathoracic Hyperthermic Perfusion for Advanced Lung Cancer / Esophageal Cancer
The goal of this clinical research study is to explore whether intrathoracic hyperthermic perfusion after radical surgery could reduce local recurrence rate(13%) for advanced lung cancer / esophageal cancer. The safety of intrathoracic hyperthermic perfusion right after surgery.
NCT03110939 — Lung Cancer
Status: Withdrawn
http://inclinicaltrials.com/lung-cancer/NCT03110939/
Monitoring Efficacy of Radiotherapy Based on Next Generation Sequencing Liquid Biopsy Technique in Lung Cancer and Esophageal Cancer: a Prospective Study
Lung cancer, one of the malignant tumors which poses a threat to human's health, has increased morbidity and mortality recently. Radiotherapy, as one of the common treatments, has important value in clinical application. Esophageal cancer, one of the most common digestive system cancers, has poor prognosis and high mortality. Esophageal cancer has high aggressive and many patients can't get surgical treatment because of the tumor metastasis at the time of diagnosis.Currently, chemoradiotherapy has become one of the standard treatment regimens for patients with unresectable esophageal cancer in National Comprehensive Cancer Network(NCCN). So radiotherapy is one of the most important treatments in esophageal cancer. Currently, the efficacy evaluation method of radiotherapy is by imaging examination after several courses of treatment. However, new reports suggest that circulating tumor DNA(ctDNA) has the potential to be an indicator of therapeutic effectiveness and recurrence risk.
NCT04014465 — Lung Cancer
Status: Recruiting
http://inclinicaltrials.com/lung-cancer/NCT04014465/
Cancer of the Oesophagus or Gastricus: New Assessment of the Technology of Endosonography COGNATE
RATIONALE: Diagnostic procedures, such as endoscopic ultrasound, may help doctors learn the extent of stomach cancer or esophageal cancer. PURPOSE: This randomized clinical trial is studying how well endoscopic ultrasound works in diagnosing cancer in patients with localized stomach cancer or esophageal cancer.
NCT00629863 — Gastric Cancer
Status: Completed
http://inclinicaltrials.com/gastric-cancer/NCT00629863/
Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer
The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet [Impact (R), Novartis] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.
NCT00333099 — Head and Neck Cancer
Status: Completed
http://inclinicaltrials.com/head-and-neck-cancer/NCT00333099/
A Phase II, Multi-Center Study of Interventional Spray Cryotherapy for Early-Stage Esophageal Cancer (ICE-Cancer)
The goal of this study is to evaluate the safety and efficacy of endoscopic spray cryotherapy using the CSA Medical, Inc. truFreeze System for patients with previously untreated early-stage cancer (T1a, N0, M0) who are ineligible or refuse conventional therapy including surgery, chemotherapy, radiation therapy, and endoscopic resection. It is hypothesized that one of the two following outcomes will occur: 1. Complete response to therapy: complete tumor eradication confirmed through histologic examination of biopsy specimens from the targeted esophageal tissue site; 2. Stable disease: tumor remission is not attained, but disease progression is halted.
NCT01868139 — Esophageal Cancer
Status: Terminated
http://inclinicaltrials.com/esophageal-cancer/NCT01868139/
Chemoradioresistance in Prospectively Isolated Cancer Stem Cells in Esophageal Cancer-Organoid: RARE STEM-Organoid
Rationale: Current standard treatment of localized esophageal cancer (EC) with neoadjuvant chemoradiotherapy (nCRT) followed by esophagectomy with curative intent results in 30% complete, 40-60% partial and 20% no-response at pathologic examination. Clinical response of nCRT is usually evaluated with PET-CT. However, response measurements are currently still insufficient in optimizing EC treatment. Proper pre-surgical response prediction may allow individualized treatment with esophagus-preservation in complete responders or switching to an alternative treatment in non-responders. Interestingly, in many tumors, a subset of cells has been found to possess cancer stem cell (CSC) properties with associated signaling as drivers of tumor (re-)growth and therapy resistance. Response of CSC-derived tissue resembling in vitro cultured tumor organoids may reflect patient's tumors sensitivity to therapy. Objective: To create a patient derived organoid model for EC patients to predict the pathologic tumor response to nCRT in clinical practice. This will allow a more personalized approach in future treatment of locally advanced EC. Study design: Fresh esophageal tumor material will be collected during diagnostic endoscopic ultrasound (EUS) in participating patients. These biopsies will be used to select cancer stem cells, which will be cultured to derive organoids (esophageal cancer patient derived organoids; EC-PDO). When the EC-PDO contain sufficient cells, these cells will be treated with radiotherapy and/or chemotherapy in order to obtain dose-response curves. The response of these EC-PDOs will be compared to the actual tumor response to nCRT treatment in these EC patients, which will be assessed at the definitive pathologic examination of the resection specimen after esophagectomy with curative intent. Study population: All patients with curatively treatable and resectable esophageal cancer (adenocarcinoma or squamous cell carcinoma) can be included in this trial. Main study parameters/endpoints: The main endpoint is response prediction to chemoradiotherapy by EC-PDO; the steepness of the dose response survival curve in the organoids in relation to the pathologic response after resection in the clinical situation. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients will be asked to undergo 3 to 6 additional biopsies during endoscopic ultrasonography (EUS) for the TNM staging of the tumor. The risk of these additional biopsies is not greater than the biopsies for the diagnosis of EC. The patient will not benefit from participation in this trial. For the future approach we can get more insight into the mechanism of (chemo)radiation response or resistance to nCRT, which might lead to a better patient selection and more individualized esophageal cancer treatment in the future. This improvement in selection and treatment can result in less over or under-treatment of these EC patients.
NCT03283527 — Esophageal Cancer
Status: Recruiting
http://inclinicaltrials.com/esophageal-cancer/NCT03283527/
A Phase Ib/II, Open-Label, Multicenter, Randomized, Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer or esophageal Cancer (Morpheus-Gastric and esophageal Cancer)
A Phase Ib/II, open label, multi-center, randomized study designed to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of immunotherapy-based treatment combinations in patients with locally advanced unresectable or metastatic G/GEJ cancer (hereafter referred to as gastric cancer) and esophageal cancer. Two cohorts of patients with gastric cancer have been enrolled in parallel in this study: the second-line (2L) Gastric Cancer Cohort consists of patients with gastric cancer who have progressed after receiving a platinum-containing or fluoropyrimide-containing chemotherapy regimen in the first-line setting, and the first-line (1L) Gastric Cancer Cohort consists of patients with gastric cancer who have not received prior chemotherapy in this setting. In each cohort, eligible patients will be assigned to one of several treatment arms. Additionally, a cohort of patients with esophageal cancer who have not received prior systemic treatment for their disease will be enrolled in this study. Eligible patients will be randomized to chemotherapy or the combination of chemotherapy with checkpoint inhibitor immunotherapy.
NCT03281369 — Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/other/NCT03281369/
A Phase II Study of the mTOR Inhibitor RAD001 in Previously Treated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Stomach
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with previously treated unresectable or metastatic esophageal cancer or stomach cancer.
NCT00985192 — Gastric Cancer
Status: Completed
http://inclinicaltrials.com/gastric-cancer/NCT00985192/
Randomised Phase III Study of Docetaxel vs Active Symptom Control in Patients With Relapsed Oesophago-gastric Adenocarcinoma
RATIONALE: Analgesics, antiemetics, steroids, and radiation therapy are effective in helping to control symptoms caused by cancer. It is not yet known whether these treatments are more effective when given with or without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer. PURPOSE: This randomized phase II trial is studying symptom control given together with docetaxel to see how well it works compared with symptom control given without docetaxel in treating patients with relapsed esophageal cancer or stomach cancer.
NCT00978549 — Pain
Status: Completed
http://inclinicaltrials.com/pain/NCT00978549/