Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma in Situ

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Individuals with a pathologically confirmed diagnosis of gastric cancer

Individuals without cancer at the time of blood sampling

A panel of microRNA, whose expression level is tested in serum samples.

DESTINEX

Ajay Goel, PhD

Silei Sui

Caiming Xu

Yasuhiro Kodera

Mitsuo Kanda

Yuji Toiyama

Yoshinaga Okugawa

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. Because conventional endoscopy is invasive and costly, gastric cancer is currently not considered to be screenable at a population level. However, if one could find less invasive and cheaper tools that accurately detect gastric cancer in its early stages, it could make a significant difference. Accurate biomarkers could help identify patients with gastric cancer before it becomes incurable.

This study aims to develop a non-invasive test to detect gastric cancer early. It consists of four phases:

1. Discovering potential biomarkers with a comprehensive and genome-wide transcriptomic sequencing analysis that will involve gastric cancer tissue, normal tissue, and serum samples from patients with gastric cancer, as well as samples from people without the disease.
2. Using machine learning to develop a combination "signature" of cell-free (cf) and exosomal (exo)-miRNA in serum specimens from a training cohort.
3. A validation of this signature in an independent cohort to confirm its accuracy.
4. An evaluation of the temporal trend of this signature in paired samples collected pre-surgery and post-surgery to investigate their potential and specificity as indicators of minimal residual disease.

In summary, this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early. Success could lead to significant improvements in clinical practice by catching cancer when it is most treatable. By combining different genetic markers (cell-free microRNA and exosomal microRNA) for accuracy, this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future.

Formalin-fixed and paraffin-embedded tissue samples Serum

Stomach Cancer Exosome-based Detection

Early Detection of Stomach Cancer With a Liquid Biopsy Based on Exosomal Micro-RNA

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

City of Hope Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Antioxidants

Adjuvant chemotherapy regimen (XELOX or paclitaxel+carboplatin) + Oncoxin 25 ml twice daily for 20 days. In case of nausea/vomiting after ONCX use patients were advised to dilute it in water, juice or milk. Patients with BMI \<20 and serum albumin levels \<30 g/l received nutritional support.

ONCOXIN®

It is expected that additional support with certain micronutrients may improve prognosis, decrease the frequency of side effects and complications and maintain high relative dose intensity of anticancer treatments. Food supplement ONCOXIN (ONCX) contains amino acids, vitamins, minerals and biologically active substances of natural origin with high immunostimulatory and antioxidant activity. Present study is a real world experience study intended to evaluate the efficacy of ONCX in cancer patients.

The study was conducted at 9 centers across the Russia and Kazakhstan. Patients were allocated in 2:1 comparison groups for the ONCX and control groups, respectively. A total of 133 patients were enrolled in the study; 84 in the ONCX group and 49 as controls.

ONCX contains microelements, vitamins, amino acids and certain naturally occurring, biologically active substances.

It is expected that additional support with certain micronutrients may improve prognosis, decrease the frequency of side effects and complications and maintain the Quality of life in cancer patients.

Study multicenter open-label nonrandomized clinical trial in two parallel groups with a 20-day treatment period. No follow-up period was intended. Following visits were scheduled: Visit 1 - the first day of 2nd and further course of ACT before ACT drugs administration; Visit 2 - 7±1 days before next course of ACT; Visit 3 - the day of next course of ACT before ACT drugs administration (21±3 days after Visit 1).

It is expected, that the proportion of patients with MCID improvement in total SDS ESAS was 50% in ONCX group and 20% in control group (with baseline total SDS ESAS of 30 points). Based on patients' allocation as 2:1 in comparison groups for the ONCX and control groups, respectively, alpha 0.05 and power not less than 0.9 data of 120 patients has to be analyzed. With the dropout of 25% 150 patients has to be included in the study (100 ONCX/50 controls).

Oncoxin® and Quality of Life in Cancer Patients

ONCOXIN® and Quality of Life in Cancer Patients in a Real World Setting Study

The proportion of patients who had an improvement in the QoL corresponding to the minimal clinically important difference (MCID) that any patient was able to feel at Visits 2 in total SDS ESAS (6 points within patient change for improvement)

Common toxicity criteria NCI-CTC. Common Terminology Criteria for Adverse Events (AE) is a descriptive terminology which can be utilized for Adverse Event reporting. A grading (severity) scale is provided for each AE term.

Body Mass Index (BMI) combined with albumin. High body mass index (BMI) has been inconsistently associated with overall survival. Preoperative body mass index, blood albumin and triglycerides predict survival for patients with gastric cancer.

Catalysis SL

Oxaliplatin

Capecitabine

Antimetabolites

toripalimab 240 mg d1; q3w, up to two cycles.

Toripalimab

oxaliplatin 130 mg/m2 QD, d1,q3w, up to two cycles

oxaliplatin

apecitabine 1000 mg/m2 BID, d1-d14 ,q3w, up to two cycles

capecitabine

Aiping Zhou, doctor

Aiping Zhou, MD

Ai ping Zhou

Gastric cancer (GC) is one of the most common malignancies. According to the global cancer statistics 2018, there were 1,033,701 new cases of gastric cancer per year, ranked the fifth place in new tumors, and 782,685 deaths, ranked the second place in cancer deaths. At present, surgery is the only way to cure gastric cancer, but the 5-year survival rate is only 20%-30%. studies have confirmed that neoadjuvant therapy could improve the R0 resection rate and overall survival, which is considered a better treatment strategy.

PD 1 monoclonal antibody is definitely effective in neoadjuvant therapy in other tumors such as NSCLC and bladder cancer, especially in PD-L1+ patients. However, there is no research of PD-1 monoclonal antibody in neoadjuvant therapy of gastric cancer. Thus we plan to conduct this prospective phase II clinical trial, evaluating the safety and efficacy of toripalimab, also known as JS001, in combination with XELOX for the neoadjuvant therapy of gastric cancer.

This phase II trial is a single-arm, open Label, non-randomized and single-center clinical study. Patients who met the study criteria will receive the combination of toripalimab (240 mg d1) with XELOX (oxaliplatin 130 mg/m2 QD, d1, capecitabine 1000 mg/m2 BID, d1-d14) of a 3-week treatment cycle up to two cycles. After the second cycle of treatment, clinical efficacy evaluation will be done by MDT according to iRECIST. For patients with CR/PR/SD, surgery will be performed within 4 weeks. For patients with disease progress, MDT will determine whether the surgery could be performed. If resection could not be done, the patients would receive Original chemotherapy with toripalimab for 1 more cycle, chemoradiotherapy or the second line chemotherapy. The primary endpoint is Major pathological response.

Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer

A Phase II Study of XELOX and Toripalimab in the Neoadjuvant Treatment of Stage II/III Gastric or GE Junction Adenocarcinoma

Proportion of subjects with residual tumor less than 10% or complete response

Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE) assessed by CTCAE v5.0.

Proportion of subjects with absence of viable tumor on surgical resection specimen as determined by local pathology review.

Proportion of subjects with initial RECIST 1.1 measurable disease who have complete response (CR) or partial response (PR) according to iRECIST

Time from Cycle 1 Day 1 treatment administration to the first documented event of: disease progression, disease recurrence following surgery (preferably biopsy proven), or death - whichever occurs first.

Time from Cycle 1 Day 1 treatment administration to death due to any cause.

Aiping Zhou

Chief physician

Robotic radical gastrectomy

Yanbing Zhou

Zhou Yanbing

To evaluate the clinical efficacy of robot radical Gastrectomy and laparoscopic radical Gastrectomy, patients with gastric adenocarcinoma (cT2N+M0 or cT3-4a/N+M0, phase II and III) undergoing neoadjuvant treatment were selected as subjects.

1. Research background In the world, gastric cancer is a common malignant tumor, with the incidence rate ranking fourth and tumor related deaths ranking second. Although the incidence rate of gastric cancer in western countries has a downward trend, it still remains at a high level in East Asia. China is a high incidence area of gastric cancer and a traditional country of gastric cancer. A large number of cases have brought patients a heavy Disease burden.

   Unlike early diagnosis and treatment in developed countries such as Japan and South Korea, gastric cancer in China is mostly diagnosed in the middle to late stage, and the treatment effect is not yet satisfactory. Locally advanced gastric cancer remains the main challenge for the treatment of gastric cancer. The current treatment strategy for locally advanced gastric cancer is a multidisciplinary treatment strategy centered on surgery. Since the MAGIC trial, neoadjuvant chemotherapy for gastric cancer has been widely accepted. Possible advantages of neoadjuvant therapy include better patient tolerance, tumor progression, and elimination of occult micro metastasis to improve radical resection and better prognosis.

   Since the first laparoscopic gastric cancer surgery reported by Kitano et al. in 1994, it has undergone more than 20 years of continuous exploration and innovation. Laparoscopic gastric cancer surgery has rapidly developed worldwide and has now been widely recognized both domestically and internationally. A large number of studies on laparoscopic gastric cancer surgery and laparotomy have confirmed that Laparoscopy has the advantages of less complications, less blood loss during operation, less postoperative pain and inflammatory reaction, rapid recovery of gastrointestinal function, short postoperative hospital stay, and good cosmetic effect, and the oncological treatment effect is equivalent to that of open surgery. At present, laparoscopic surgery for gastric cancer is gradually developing, but the traditional Laparoscopy is limited in fine operation, vision and other aspects. In order to overcome the limitations of laparoscopic surgery, the da Vinci robot system has emerged. As an advanced laparoscopic system, the robot has solved many shortcomings of conventional laparoscopy with its unique advantages. A clearer field of view can better display small anatomical structures, which is conducive to achieving skeletonization of gastric perivascular structures. At the same time, it reduces the difficulty of lymph node dissection and bleeding. At the same time, it has a simulated wrist with 7 degrees of freedom, greatly improving the flexibility of operation and reducing the difficulty of suturing. In the field of gastric cancer surgery, since Hashizume et al. first reported robot gastric cancer surgery in 2002, there have been increasing reports on the safety and feasibility of robot surgical systems applied to gastric cancer treatment. At present, a large number of studies have confirmed that compared with Laparoscopy, robotic surgery can also achieve radical resection, and has the advantages of less intraoperative blood loss and more lymph nodes to be cleared.

   However, the safety and effectiveness of da Vinci surgery are still unclear for patients after neoadjuvant chemotherapy. The pro fibrotic response caused by chemotherapy and the loss of normal tissue planes caused by cytotoxicity pose new technological challenges. Whether less trauma and more lymph node dissection are equivalent to better postoperative safety, chemotherapy completion rate, and survival benefits remains a key issue in clinical practice. Previous RCT studies have shown that LADG seems to provide better postoperative safety and adjuvant chemotherapy tolerance than ODG for locally advanced gastric cancer patients receiving neoadjuvant chemotherapy. Therefore, further targeted research is needed to explore robotic gastric cancer surgery for neoadjuvant therapy.

   Based on the above background, the safety and effectiveness of robotic Gastrectomy in gastric cancer patients undergoing new adjuvant treatment is a key clinical problem in gastric surgery that needs to be solved urgently. Therefore, on the basis of traditional laparoscopy and robotic laparoscopy, this study compared the short-term and long-term clinical efficacy of Leonardo da Vinci Gastrectomy in the neoadjuvant treatment of gastric cancer with gastric adenocarcinoma patients undergoing neoadjuvant treatment.
2. Research Purpose To evaluate the clinical efficacy of robot radical Gastrectomy and laparoscopic radical Gastrectomy, patients with gastric cancer (cT2N+M0 or cT3-4a/N+M0, phase II and III) undergoing neoadjuvant treatment were selected as subjects.
3. Research Design Adopting a multicenter, prospective, open, randomized, controlled, and non-inferiority validation design.

3.2 Comparison and grouping Group A (experimental group): Performing robot radical gastrectomy for gastric cancer Group B (control group): Performing laparoscopic radical gastrectomy for gastric cancer 3.3 Estimation of Sample Size This study used the 3-year disease-free survival rate (DFS) as the main efficacy evaluation indicator. Using 1:1 random grouping, The planned collection of cases is 1.5 years, and the last case will be followed up for another 3 years after enrollment. Due to the lack of previous similar research results, the dual standard method described in Neuenschwander et al.'s paper was used to calculate the required sample size to determine the non disadvantages of robotic versus laparoscopic gastric cancer radical surgery based on DFS \[20\]. The first criterion is the critical threshold for HR valuation to be less than 1.08, while the second criterion requires that the upper limit of the one-sided 95% confidence interval for non inferiority margin valuation be less than 1.24. The inspection level is taken as 0.05 (bilateral), and the inspection efficiency is taken as 0.8. Using PASS calculation, the sample size N=269, which means that each group requires 268 people. Considering possible exclusion and loss of follow-up cases (10% dropout rate), the final sample size required for each group is 294, with a total of 588 cases required.

3.4 Blind method: This study adopts an open design 3.5 Research cycle Case enrollment cycle: Complete the required case enrollment within 1.5 years. Follow up period: The first case is included as the starting point for follow-up, and the main research purpose is 3 years after the last case is included End point of follow-up. Expected time: June 2023- December 2024 (completion of enrollment) - December 2027 (completion of follow-up) 3.6 Randomization This study adopts a central dynamic randomization method based on minimization, considering stratified factors such as age, BMI, preoperative staging, chemotherapy regimen, and tumor location. After each case is selected, a dedicated person from the participating research center is responsible for inputting the selected case information (age, BMI, preoperative staging, neoadjuvant treatment plan, tumor location) into the central randomization system. The system will immediately return the randomization results to the research center. Researchers from each participating research center should strictly follow the grouping to determine whether the subjects will enter Group A (experimental group) or Group B (control group).

Group A (experimental group): Performing robot radical gastrectomy Group B (control group): Performing laparoscopic radical gastrectomy

A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer

A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Gastrectomy in Neoadjuvant Gastric Cancer Patients

The Affiliated Hospital of Qingdao University

Laparoscopic bursectomy and D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach are that anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN)

Laparoscopic D2 lymphadenectomy will be performed for the treatment of patients assigned to this group.The key of this approach is that D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN) without dissociation of anterior lobe of transverse mesocolon and capsula pancreatis.

The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy.

Laparoscopic bursectomy and D2 lymphadenectomy

D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).

Laparoscopic D2 lymphadenectomy

Jin Wan, professor

Liao-nan Zou, professor

liao-nan Zou, professor

xin-quan Lu, Dr

To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial.

To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective randomized controlled trial will be performed in the GI department, Guangdong provincial hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases with advanced gastric cancer, will be needed after calculated by the statistics. The 100 cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years' and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall survival（OS）rate, operative time, the total blood loss, the intra-operative complication and the post-operative complication, the number of lymph nodes dissected, the number of conversion to open laparotomy, and the other outcomes are the average time of ground activities, the hospital stay. The data in two groups will be compared.

Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer

Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in II,III Stage Gastric Carcinoma: A Prospective, Randomized, Single Blind, Parallel Group Clinical Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stomach Cancer Exosome-based Detection	NCT06342427	Gastric Cancer Gastric Adenoca... Gastric Cancer ... Gastric Neoplas... Gastric Lesion Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer,... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ... Gastric Cancer ...	DESTINEX	18 Years -	City of Hope Medical Center
Oncoxin® and Quality of Life in Cancer Patients	NCT03550482	Gastric Cancer ... Non-small Cell ... Non-small Cell ... Gastric Cancer ...	ONCOXIN®	50 Years - 70 Years	Catalysis SL
Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer	NCT04119622	Gastric Cancer ... Gastric Cancer ...	Toripalimab oxaliplatin capecitabine	18 Years - 75 Years	ChineseAMS
A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer	NCT06042998	Gastric Cancer ... Gastric Cancer ...	Robotic radical...	18 Years - 75 Years	The Affiliated Hospital of Qingdao University
Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer	NCT02969148	Gastric Cancer ... Gastric Cancer ...	Laparoscopic bu... Laparoscopic D2...	18 Years - 80 Years	Guangdong Provincial Hospital of Traditional Chinese Medicine
Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer	NCT04119622	Gastric Cancer ... Gastric Cancer ...	Toripalimab oxaliplatin capecitabine	18 Years - 75 Years	ChineseAMS

Spots Global Cancer Trial Database for gastric cancer stage ii