Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Esophageal Neoplasms

Stomach Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Esophageal Diseases

Stomach Diseases

Esophageal Cancer

Quality of Life

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Pharmaceutical Solutions

Hematinics

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Folic Acid

Folinic Acid

Folate

Vitamin B9

Ocoxin-Viusid group (Experimental). Oral solution of Ocoxin-Viusid (vials of 30 ml), at a rate of 60 ml daily (1 vial every 12 hours), administrado preferably administered after breakfast and dinner. The product will dilute in water, milk or juice. The treatment will have a period of 19 weeks, starting 2 weeks before the onco-specific treatment with FOLFOX chemotherapy and will end 3 weeks after the end of the sixth cycle of chemotherapy. QT FOLFOX will be prescribed intravenously every 14 days for 6 cycles as follows: Oxaliplatin (85 mg x m2) on day 1 Folinic acid (200 mg x m2) on day 1 and 2 5 Fluoracil (400 mg x m2, bolus) on day 1 and 2 5 Fluoracil (600 mg x m2, continuous infusion) on day 1 and 2

Ocoxin-Viusid®

Our main objective is to evaluate the effect of Ocoxin-Viusid on the quality of life of patients with advanced stomach cancer and esophagogastric junction. The Ocoxin-Viusid nutritional supplement is expected to improve quality of life and tolerance to treatment with Chemotherapy.

* To evaluate the effect of Ocoxin-Viusid on the quality of life of patients
* To evaluate the toxicity of Ocoxin-Viusid in combination with chemotherapy (QT).
* To assess the influence of Ocoxin-Viusid on tolerance to treatment with chemotherapy.
* Identify the changes that occur in the nutritional status of patients receiving the supplement.

Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction

Effect of Ocoxin®-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced Stomach Cancer and Esophagogastric Junction. Phase II Clinical Trial.

Karnofsky index (Score of 0-100 points at intervals of 10).

EORTC QLQ-C30 (score of every item and global score)

EORTC QLQ-STO22 if gastric cancer (score of every item and global score)

EORTC QLQ-OG25 if is a gastric esophagus union cancer (score of every item and global score)

Body mass Index calculated by Weight/(Height\*Height), the weight expressed in Kg and, the height expressed in meters.

Adverse Reactions (It will consider the compliance to the Chemotherapy treatment in terms of time and doses plan and, it will classify in "Yes, No").

AE will be measured as: - Type of AE (Description of the EA that is presented) - Causal Agent (QT, Oncoxin -Viusid, Other) - Seriousness of the AE (Serious, Not serious) - Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death, according to the Common Criteria of Adverse Event Terminology (CTCAE) version 4.0) - Duration of the AE (Difference between the start and end date of the event) - Causal relationship (Very likely/Definitive, Probable, Possible, Unlikely, Not related, Not assessable/Not classifiable according to the WHO classification) - Attitude towards treatment (No change, Modification of doses, Temporary interruption, Definitive interruption)

Hematological (hemoglobin, platelets, total leukocytes, CAN) and Blood chemistry (AST, ALT, total bilirubin, creatinine, glycemia, albumin, total proteins, alkaline phosphatase) .The values will be recorded according to the units established for each test, reporting as normal, abnormal, not clinically significant, abnormal clinically significant and not performed, according to the normality ranges of the institution)

Catalysis SL

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Adenocarcinoma

Genital Diseases, Female

Genital Diseases

Adenocarcinoma, Scirrhous

Linitis Plastica

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

TKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week.

TKI258

Novartis Pharmaceuticals

This is a prospective, open-label, single-arm, non-randomized, multi-center, phase II proof of concept (PoC) study with a two-stage design and Bayesian interim monitoring to evaluate efficacy and safety of single agent TKI258 in adult patients with scirrhous gastric carcinoma (SGC) that have progressed after one or two prior systemic treatments.

A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients

A Single-arm, Multi-center, Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Adult Patients With Advanced Scirrhous Gastric Carcinoma That Have Progressed After One or Two Prior Systemic Treatments

Eight-week DCR is defined as the proportion of patients with best overall response of CR, PR or SD at the end of Week 8 as per local investigator's assessment.

TTP is defined as the time from the start date of study treatment to the date of event defined as the first documented progression or death due to underlying cancer as per local investigator's assessment.

ORR is defined as the proportion of patients with best overall response of CR or PR as per local investigator's assessment.

PFS is defined as the time from the start date of study treatment to the date of event defined as the first documented progression or death due to any cause as per local investigator's assessment.

OS is defined as the time from the start date of study treatment to the date of death from any cause.

Eight-week DCR is as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.

TTP as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.

Safety will be measured in terms of type, frequency and severity of adverse events according to CTCAE v4.03.

Pharmacokinetics (PK) of TKI258 at each scheduled time point of single dose and steady dose.

ORR as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.

PFS as defined above. An independent central review of the radiological data will be performed and the results will be used for secondary supportive analyses.

Capecitabine

Apatinib

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

In this arm, patients will receive a daily oral treatment with Apatinib 500mg.

In this arm , patients will receive capecitabine 1000mg/m2 twice for 14 days, and repeat every 3 weeks.

In this arm, no additional treatment will be given, and patients will be followed up at regular time

Capecitabine: 1000mg/m2 bid po, d1-14, q3w

The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of Apatinib/Capecitabine after fluorouracil and platinum based first-line chemotherapy in advanced gastric cancer.

Up to now, whether maintenance therapy after first line treatment can bring survival benefits to patients with advanced gastric cancer is unknown, and let alone which drug is most suitable. Our study is designed to prove whether the maintenance treatment of Apatinib or Capecitabine are better than observation after fluorouracil/platinum based first-line chemotherapy in advanced gastric cancer

The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer

A Phase III Study of Comparing the Maintenance Treatment of Apatinib, Capecitabine and Observation After First-line Therapy in Advanced Gastric Cancer

we will use EORTC QLQ-C30 to evaluate QoL.

we will use CTC AE4.0 to evaluate adverse events.

PFS is calculated from the time of randmization to disease progression or death whichever happen first

OS is calculated from the time of randmization to death

Fudan University

Principal Investigator and Clinical Professor

Symptoms and General Pathology

Recurrence

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

CRS-207 and pembrolizumab will be administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) will be administered by intravenous (IV) infusion over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10e9 colony-forming units \[CFU\]) will be administered by IV infusion over 1 hour on Day 2. If the infusions are well tolerated, pembrolizumab and CRS-207 may be administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab will continue to be administered on Day 1 at each treatment cycle (every 3 weeks); CRS-207 will be administered once every 6 weeks (every other cycle). Treatment will continue for up to 35 cycles as long as there is adequate safety and potential for clinical benefit.

CRS-207

Administered by IV infusion over 30 minutes.

The purpose of this study is to determine whether CRS-207 in combination with pembrolizumab is safe and effective in adults with recurrent or metastatic gastric, gastroesophageal junction, or esophageal cancer who have received one or two prior chemotherapy regimens for advanced disease.

Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers

A Phase 2, Open-label Evaluation of CRS-207 and Pembrolizumab in Adults With Recurrent or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinomas

ORR was evaluated based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each evaluable subject as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and given the following hierarchy of overall response results: complete response (CR) \> partial response (PR) \> stable disease (SD) \> progressive disease (PD) \> not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR RECIST v1.1 values of CR, PR, SD, PD, and NE are provided for this outcome measure. .

The percentage of evaluable subjects who exhibited a post-baseline tumor assessment BOR rating of CR, PR, or SD per RECIST v1.1.

Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) according to RECIST v1.1 or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects who do not experience PD and are alive on or before the data cut-off date will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.

Number of weeks from the first date a study subject achieved an objective disease response of CR or PR according to RECIST v1.1 to the date a study subject exhibited PD or death due to any cause, estimated using KM methods with 95% CIs. Subjects who do not experience PD or death at the time of analysis will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.

Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive, or the data cut-off date, whichever is earlier.

Merck Sharp & Dohme LLC

Aduro Biotech, Inc.

AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.

Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by IV infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 CFU administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).

CRS-207 + Pembrolizumab

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Baseline characteristics provided for all subjects who were administered at least 1 dose of protocol-specified drug (the Safety Analysis Set \[SAF\]).

Study was terminated early and included a small number of subjects, and insufficient data were available to evaluate the clinical activity of the study treatment. Due to low enrollment, some protocol-specified outcome measures were not evaluated.

Medical Affairs

Analysis based upon subjects who received at least 1 dose of CRS-207 and had at least 1 evaluable post-baseline RECIST v1.1 tumor response assessment or were discontinued due to toxicity (the Evaluable Analysis Set \[EAS\]). 2 subjects did not have post-baseline tumor response assessments and could not be evaluated for this outcome measure.

Objective Response Rate (ORR)

Disease Control Rate (DCR)

Analysis of PFS was performed on subjects in the SAF.

Progression-Free Survival (PFS)

No study subjects achieved CR or PR designation, therefore, per the final SAP DOR was not derived.

Duration of Response (DOR)

Analysis of OS was performed on subjects in the SAF.

Overall Survival (OS)

Treatment cycle is once every 3 weeks. Pembrolizumab: 200 mg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle. CRS-207: 1×10e9 colony forming units (CFU) administered by IV infusion on Day 2 of Cycle 1, Day 1 of Cycles 2, 3, 4, and Day 1 every 6 weeks thereafter (every other cycle).

Overall Study

Ulcer

Stomach Ulcer

Hu Liu, M.D.

The investigators study the feasibility of a novel method in oncology based on breath analysis with a nanosensors array for identifying gastric diseases. Alveolar exhaled breath samples collected from volunteers referred for upper endoscopy or surgery are analyzed using a custom-designed array of chemical nanosensors based on organically functionalized gold nanoparticles and carbon nanotubes. Predictive models are built employing discriminant factor analysis (DFA) pattern recognition method. Classification accuracy, sensitivity and specificity are determined using leave-one-out cross-validation or an independent blind test set. The chemical composition of the breath samples is studied using gas chromatography coupled with mass spectrometry (GC-MS).

A pilot study is conducted first (enlistment of 160 subjects at the Department of Oncology, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.)

The pilot study is followed by a large-scale clinical trial to confirm the preliminary results of the Chinese pilot study (enlistment of 800 subjects at the Digestive Diseases Centre GASTRO, Riga East University Hospital, 6 Linezera iela, LV1006 Riga, Latvia). 25% of the samples are used as independent blind test set. The samples are blinded by the medical team and are not disclosed until prediction of blind sample identity is complete.

To further prove the diagnosis of GC from exhaled breath and seek the interrelationship among Breathomics, metabolomics and transcriptomics, saliva samples from about 200 patients are collected from volunteers referred for upper endoscopy or surgery are analyzed using Ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS). Simultaneously, RNA sequencing are preformed on gastric cancer tissue samples and paracancerous tissue samples collected from same group of volunteers. The data of salivary metabonomics and transcriptomics were integrated and analyzed on the on Kyoto Encyclopedia of Genes and Genomes to confirm the diagnostic validity of salivary metabonomics.

Number of patients that will have a definitive diagnosis and Alveolar exhaled breath samples collected from individuals with Tedlar® bags (Keika Ventures, LLC) after endoscopy.. Two breath samples were collected from each person tested.

Two-bed sorption tubes filled with the following sorbents were used as traps for sample collection with simultaneous preconcentration: 100mg matrix Tenax TA and 50mg matrix Tenax TA (35-60 mesh; purchased from Supelo, Bellefonte, PA). Sorbents were separated by glass wool. The samples were collected at a total flow through sorption trap of 200ml/min.

One sample was used for analysis with the nanosensors array, and the other sample was used for Gas Chromatography coupled with Mass Spectrometry (GC-MS) analysis.

Cancer tissue and paracancerous tissue samples were collected in the process of surgical resection. After collection in the operating room, the samples were immediately placed in - 5 ℃ dry ice and transferred to the laboratory. Then, the samples were frozen in liquid nitrogen for 30 minutes, and then placed in - 80℃ freezer for cold storage. After that, the samples were divided into several batches and transported in dry ice for subsequent transcriptome analysis. All the saliva samples were collected using 2ml cryopreservation tube during early morning before surgery or endoscopic resection. The patient had been told not to eat after 22 o'clock the night, and not to drink water, smoke, brush teeth or exercise violently one hour before the collection. The saliva samples were sealed in the -80 C refrigerator after collection and then transported in a foam box equipped with dry ice, followed by UHPLC-MS analysis.

exhaled breath of volunteers; saliva; tissue

Diagnosis of Gastric Lesions From Exhaled Breath and Saliva

Study of the Exhaled Breath and Salivary Metabolites of Patients With Malignant or Benign Gasctric Lesions

Salivary samples collected from 200 subjects referred for upper endoscopy or surgery are analyzed using Ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS). Predictive models are built employing discriminant factor analysis (DFA). Classification accuracy, sensitivity and specificity were determined using leave-one-out cross-validation.

Data from breathomics, salivary metabonomics and transcriptomics are integrated to seek the proof of breath diagnosis at different levels.

Proof-of-concept:

Alveolar exhaled breath samples collected from 160 subjects referred for upper endoscopy at The First Affiliated Hospital of Anhui Medical University are analyzed using a custom-designed array of chemical nanosensors. Predictive models are built employing discriminant factor analysis (DFA). Classification accuracy, sensitivity and specificity were determined using leave-one-out cross-validation. The chemical composition is studied using gas chromatography coupled with mass spectrometry (GC-MS).

Confirmation of proof-of-concept:

Alveolar exhaled breath samples collected from 800 subjects referred for upper endoscopy at Riga East University Hospital are analyzed as was used in the pilot study. Predictive models are built as in the pilot study,using a training set of only 75% of the samples. Classification accuracy, sensitivity and specificity are determined using an independent blind test set (25% of the samples)

Specifically, to compare the VOCs that distinguish between malignant and benign gastric lesions in the Chinese and Latvian cohorts. The cohorts from China and Latvia are matched in terms of sample size, gender ratio, average age, and smoking habits.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction	NCT03549494	Stomach Neoplas... Gastrointestina... Digestive Syste... Esophageal Neop... Head and Neck N... Gastrointestina... Digestive Syste... Esophageal Dise... Stomach Disease... Esophagogastric...	Ocoxin-Viusid®	18 Years -	Catalysis SL
A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients	NCT01576380	Adenocarcinoma,... Linitis Plastic... Stomach Neoplas... Stomach Disease... Neoplasms by Si... Neoplasms	TKI258	20 Years -	Novartis
The Maintenance Treatment of Apatinib/Capecitabine Versus Observation in Advanced Gastric Cancer	NCT03889626	Stomach Neoplas... Gastrointestina... Stomach Disease... Digestive Syste... Capecitabine Apatinib Neoplasms Molecular Mecha...	Apatinib Capecitabine	18 Years - 90 Years	Fudan University
Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction	NCT03549494	Stomach Neoplas... Gastrointestina... Digestive Syste... Esophageal Neop... Head and Neck N... Gastrointestina... Digestive Syste... Esophageal Dise... Stomach Disease... Esophagogastric...	Ocoxin-Viusid®	18 Years -	Catalysis SL
A Phase II Study to Evaluate Efficacy and Safety of Dovitinib (TKI258) in Advanced Scirrhous Gastric Carcinoma Patients	NCT01576380	Adenocarcinoma,... Linitis Plastic... Stomach Neoplas... Stomach Disease... Neoplasms by Si... Neoplasms	TKI258	20 Years -	Novartis
Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers	NCT03122548	Gastric Adenoca... Gastroesophagea... Esophageal Aden...	CRS-207 Pembrolizumab	18 Years -	Aduro Biotech, Inc.
Diagnosis of Gastric Lesions From Exhaled Breath and Saliva	NCT01420588	Stomach Disease...		18 Years - 75 Years	Anhui Medical University
Safety and Efficacy of CRS-207 With Pembrolizumab in Gastric, Gastroesophageal Junction or Esophageal Cancers	NCT03122548	Gastric Adenoca... Gastroesophagea... Esophageal Aden...	CRS-207 Pembrolizumab	18 Years -	Aduro Biotech, Inc.

Spots Global Cancer Trial Database for stomach diseases