Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Postoperative Complications

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Robot-assisted total or subtotal Gastrectomy is carried out through daVinci platform.

(10 patients enrolled for phase 1 of the study and 15 patients for phase 2)

Robot-assisted total or subtotal Gastrectomy is carried out through Hugo platform.

(10 patients enrolled for phase 1 of the study and 15 patients for phase 2)

Robot-assisted total or subtotal Gastrectomy is carried out through Versius platform.

(10 patients enrolled for phase 1 of the study and 15 patients for phase 2)

DaVinci® Surgical System

Hugo™ RAS System

Versius® Robotic Surgery System

Simone SG Giacopuzzi, MD, Prof

Simone Giacopuzzi, MD, Prof

Maria Bencivenga, MD, Prof

The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms:

* DaVinci;
* Hugo;
* Versius.

This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one.

The questions it aims to answer are:

* Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable?
* Are there any differences between the three platforms related to the learning curve for surgeons?

Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:

1. surgery with the daVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform.

Gastrectomy for gastric cancer could be performed through open, laparoscopic and robotic approaches. In the last ten years, robotic surgery, performed with Da Vinci® Robotic System (Intuitive Surgical Inc., Sunnyvale, CA, USA) has been introduced and increasingly used globally also in the field of gastric surgery. Indeed, the technological implementation obtained with the use of robotic surgery should guarantee an easier approach to the different phases of gastric surgery, and in particular to the more complex steps relating to the reconstructive phase of the operation.

Recently, after Intuitive patent expiration, two new CE-marked robotic platforms are available in Europe for minimally invasive procedures:

* Versius® Robotic Surgery System, (Cambridge Medical Robotics (CMR) Ltd., Cambridge, UK);
* HugoTM RAS (Medtronic Dublin, Ireland; Minneapolis, MN, USA).

Both platforms are currently used for urological and gynecological procedures, but, no experiences are reported in Literature related to the field of oncological esophago-gastric surgery. In order to provide evidence regarding the new robotic platforms, the COMPAR-G study has been designed to directly compare the Da Vinci® (as standard), Versius® and HugoTM RAS robotic platforms during gastrectomy.

In this regard, this study was proposed, divided into two phases: a first phase for feasibility of surgical procedure with different platforms and the second one to evaluate the learning curve for surgeons.

This second phase will be carried out only in the event of an extension of the rental of the two new platforms for a further period of one year.

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy (COMPAR-G) in Gastric Cancer Patient.

Number of procedures in which it is necessary to convert to open or laparoscopic approach, due to surgical and/or oncological needs

Major complications are considered according to the GASTRODATA definition (Unintentional intraoperative damage to major vessels and/or organs requiring reconstruction or resection. Intraoperative bleeding requiring urgent treatment. Unforeseen medical conditions that interrupt or change the planned procedure) and according to Clavien-Dindo Classification (7 grades: I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication.

Analysis of surgical times (as minutes of the different surgical steps of the standardized procedure).

Evaluation of analysis of video of surgical procedure, as deviations from the standard.

Major complications are considered according to GASTRODATA definition (surgical and/or general) and according to Clavien-Dindo Classification (7 grades: I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

Adherence to Enhanced recovery after surgery for gastric cancer (ERAS-GC) protocol, which involves a rapid mobilisation and refeeding of patiens.

Days of recovery until the date of release

Numerical Rating Scale (NRS) 0-10 scale for the self-reported rate of pain: zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Number of patients readmitted to the hospital for postoperative complications

Number of damage due to positioning on the operating bed, during the surgical procedure

Positive margin (distal or proximal) at histological examination

EORTC QLQ-C30 questionnaire (30-item instrument designed to measure quality of life in all cancer patients) and EORTC STO-22 questionnaire (for measuring the QOL of patient with gastric cancer)

Set up of operating table, Electric connections, Draping, Undraping, Docking, Undocking, Cleaning: time in minutes

Targeted observation with "I.C.A.R.S" checklist (Interpersonal and Cognitive

Assessment for Robotic Surgery) which includes following domains:

Checklist and equipment; Interpersonal skills and Cognitive skills.

Azienda Ospedaliera Universitaria Integrata Verona

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Uterine Cervical Neoplasms

Cholangiocarcinoma

Breast Neoplasms

Pancreatic Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Transitional Cell

Sarcoma

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Adenocarcinoma of Lung

Adrenocortical Carcinoma

Biliary Tract Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Biliary Tract Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Diseases

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Pancreatic Cancer

Ovarian Cancer

Transitional Cell Carcinoma

Bile Duct Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Biliary Tract Cancer

Germ Cells Tumors

Lung Adenocarcinoma

Testicular Germ Cell Tumor

260 mg once dailly orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle

260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle

RAIN-32

Phase 2, multicenter, single-arm, open-label basket study designed to evaluate the safety and efficacy of milademetan in patients with advanced or metastatic solid tumors refractory or intolerant to standard-of-care therapy that exhibit wild-type (WT) TP53 and MDM2 copy number (CN) ≥ 8 using prespecified biomarker criteria.

Approximately 65 patients will be enrolled to receive milademetan.

Patients will receive the study drug until reaching unequivocal disease progression (per Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1), as determined by the Investigator; experiencing unmanageable toxicity; or until other treatment discontinuation criteria are met. Patients may be treated beyond tumor progression if they are experiencing clinical benefit based on the assessment of the Investigator in discussion with the Medical Monitor.

All patients will be followed for documentation of disease progression and survival information (i.e., date and cause of death). Long-term follow-up will continue every 12 weeks (± 7 days) until the endpoint of death, the patient is lost to follow-up, or for 24 months following the final dose of the study drug, whichever comes first.

Milademetan in Advanced/Metastatic Solid Tumors

A Phase 2 Basket Study of Milademetan in Advanced/Metastatic Solid Tumors (MANTRA-2)

DOR defined as the time from the date of first documentation of CR or PR according to RECIST v1.1 to the date of disease progression or death due to any cause according to Investigator assessment

PFS defined as the time from the date of the first dose of the study drug to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause according to Investigator assessment

GMI defined as the ratio of Time to Progression (TTP) with the nth line of therapy (TTPn; here defined as milademetan) to the most recent prior line of therapy (TTPn-1)

DCR defined as the percentage of patients with confirmed CR, PR, or stable disease (SD) for ≥ 16 weeks

OS as measured from the date of the first dose of the study drug until the date of death due to any cause

Rain Oncology Inc

Neoplasm Metastasis

Antineoplastic Agents

All Drugs and Chemicals

Oxaliplatin

Capecitabine

Antimetabolites

Subjects enrolled are treated with oral capecitabine 1000mg per m2 bid for two weeks（every 3 weeks）and intravenous oxaliplatin 130mg per m2（every 3 weeks）in combination with sintilimab 200mg (every 3 weeks)

oral capecitabine 1000mg per m2 bid d1-14, intravenous oxaliplatin 130mg d1 per m2, sintilimab 200mg (every 3 weeks)

sintilimab

Qiu Li, M.D.

This study aims to evaluate the efficacy and safety of Sintilimab plus CAPOX in the conversion therapy for patients with unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction

In a variety of solid tumors such as colorectal cancer, it has been confirmed that some selected advanced patients still have a chance to cure through multidisciplinary treatment. Because of the poor biological behavior of gastric cancer, few people with advanced gastric cancer can benefit from local treatment, and there are fewer related studies. However, retrospective and small sample size prospective phase II clinical studies have also shown that unresectable locally advanced and some selected limited distant metastatic gastric and gastric junction adenocarcinoma patients may also achieve long-term survival through multimodal treatment strategies. The triple drug regimens were often used as conversion regimens in previous studies. Although the efficiency was improved, the R0 resection rate was only about 60%, the disease-free survival was about 10 months, and the toxicity was high. In order to improve the survival of these patients, more effective and less toxic treatment regimens are urgently needed. Objective response rate was 76.5% with anti-PD-1 antibody nivolumab plus CapeOX. The investigators predict that this regimen will achieve good results in the conversion treatment of advanced gastric cancer. The investigators intend to carry out this study to evaluate the efficacy and safety of Sintilimab plus CAPOX in the conversion therapy for patients with unresectable locally advanced or limited metastatic adenocarcinoma of the stomach or esophagogastric junction. The primary objectives are 12-month progression- free survival (PFS) rate. Secondary objectives include safety, objective response rate (ORR), R0 resection rate , tumor regression grading（TRG）, progression- free survival (PFS) ，overall survival (OS) and exploratory biomarker assessment. Subjects enrolled are treated with oral capecitabine 1000mg per m2 bid for two weeks（every 3 weeks）and intravenous oxaliplatin 130mg per m2（every 3 weeks）in combination with sintilimab 200mg (every 3 weeks) for 3 cycles. After 3 cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\\PR\\SD. Patients with SD,PR,CR will be treated with surgery. 36 patients will be included in this study

Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

An Exploratory Study of Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Proportion of patients with Progression Free Survival in 12-month

Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients

Proportion of patients with complete resection

Assessing the grade of tumor regression according to tumor regression grading criteria

Defined as the time from the date of enrollment to the first date of documented objective progression disease (defined by RECIST 1.1) or of death from any cause

Defined as the time from the date of enrollment to the date of death from any cause

Any adverse events related with treatment with Sintilimab plus CAPOX

Sichuan University

Professor

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Durvalumab

Atezolizumab

Tremelimumab

Antineoplastic Agents, Immunological

previously treated patients with solid tumors harboring a high mutational load.

To determine the efficacy (as measured by overall tumour response rate) of the combination of durvalumab and tremelimumab when given to previously treated patients with solid tumors harboring a high mutational load.

Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors

A Phase II Whole Exome Sequencing-based Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors

measured according to RECIST (version 1.1)

Gustave Roussy, Cancer Campus, Grand Paris

Gastric Cancer Patients who underwent Chemotherapy and will have gastric cancer surgery.

Gastric cancer surgery is performed according to the Japanese Guidelines. Patients will intraoperative evaluate the edema, fibrosis and exudation.

Gastric cancer surgery

Jian-Kun Hu, MD, PhD

Wei-Han Zhang, MD, PhD

This research intend to collect the information of gastric cancer patients who received preoperative neoadjuvant chemotherapy and radical gastric ectomy at Department of Gastrointestinal Surgery, West China Hospital, Sichuan University. Base on The degree of edema, intraoperative effusion, fibrosis of connecting tissues, the investigators aim to constitute the core parameters of the tissue response grading system following neoadjuvant chemotherapy, and explore the mutual effect among the tissue response grading system, tumor regression response and long-term survival outcome of tumor patients.

Gastric cancer is ranked the third malignancy carcinoma which related deaths. In china, gastric cancer always ranked in the top three cancer-related deaths. Early diagnosis ratio of gastric caner is low in china. And the proportion of gastric cancer cases which performed surgical treatment is less than 20% at early stage Therefore, the vast majority of patients with gastric carcinoma already have locally advanced tumors at the time of diagnosis in china, and the current treatment strategy is suggested to receive comprehensive surgical gastrectomy. Current research showed strong evidence that preoperative neoadjuvant therapy represented by neoadjuvant chemotherapy (NAC) can downstaging the primary tumor to increase the possibility of a successful complete resection and destroying occult lymph node and distant micro metastases to decrease the rate of tumor recurrence., and thus provide the survival benefit for locally advanced gastric cancer patients.Therefore, the national comprehensive cancer network(NCCN)guidelines for gastric cancer treatment(2017 version 5),recommended that neoadjuvant chemotherapy (evidential level category 1 ) and neoadjuvant chemotherapy (evidential level category 2B) can be considered.for locally advanced gastric caner cases(T2-4nx).

Through the literature review, the investigators found that residual tumor evaluation criteria which was promoted by Becker and the criteria for tumor regression response which recommended by NCCN guidelines can be used to evaluate the tumor regression after chemotherapy/radiotherapy. However, the rating criteria for connective tissue response around the tumor after chemotherapy/radiotherapy still remain blank area. During the clinical practice, surgeons should not ignored the edema and fibrosis of tumor and connective tissue after chemotherapy/radiotherapy which existed objectively. Recent research generally believed that preoperative chemotherapy with/or not with radiotherapy may lead to edema of gastrointestinal tract and perigastric tissues, intraoperative effusion and fibrosis of tumor and lymph nodes bearing tissues，which may increase the difficulty of tissue dissociation and lymph node dissection, increase the risk of surgical trauma, and may lead to increased incidence of postoperative complications. There is till a lack of evaluation criteria for the degree of tissue fibrosis/edema after radiotherapy and chemotherapy which may have impact on surgery and long-term survival prognosis of patients.

Therefore, it is necessary to analyze and evaluate tissue edema and fibrosis after chemotherapy/radiotherapy and establish corresponding criteria system to explore whether if the tissue fibrosis and edema are involved with the degree of tumor retreat after chemotherapy/radiotherapy at two aspects: general evaluation and histopathology. The interaction effects of tissue fibrosis and edema with the difficulty of operation and incidence rate of postoperative complications. In addition, the mutual effect of tissue fibrosis and edema with the final long-term survival outcome of tumor patients needs to be evaluated from two aspects: general observation and histopathology evaluation.

General Tissue Response Classification System After Chemotherapy

The Establishment of General Tissue Response Classification System After Chemotherapy According to Gastric Cancer Patients With Neoadjuvant Chemotherapy

To assess the degree of fibrosis, edema and exudation in tumor tissue and main perigastric lymph node area during the operation.

To assess the degree of edema in tumor tissue and main perigastric lymph node area during the operation.

To assess the degree of exudation in tumor tissue and main perigastric lymph node area during the operation.

To assess the degree of edema in tumor tissue and main perigastric lymph node area by pathological section.

To assess the degree of fibrosis in tumor tissue and main perigastric lymph node area by pathological section.

Calculated by the number of patients with any operative complication as the numerator and the number of patients undergoing surgical treatment.

West China Hospital

Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy	NCT06362070	Gastric Cancer Gastrointestina... Neoplasms Gastric Diffuse... Gastric Neoplas... Stomach Adenoca...	DaVinci® Surgic... Hugo™ RAS Syste... Versius® Roboti...	18 Years - 80 Years	Azienda Ospedaliera Universitaria Integrata Verona
Milademetan in Advanced/Metastatic Solid Tumors	NCT05012397	Solid Tumors Head and Neck C... Cholangiocarcin... Sarcoma Lung Adenocarci... Bladder Urothel... Stomach Adenoca... Breast Cancer I... Ovarian Carcino... Cervical Cancer Non Small Cell ... Gastric Cancer Biliary Tract C... Melanoma Pancreas Cancer MDM2 Gene Ampli... Testicular Germ... Adrenocortical ...	RAIN-32	18 Years -	Rain Oncology Inc
Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction	NCT04263870	Gastroesophagea... Stomach Adenoca... Locally Advance... Metastatic Gast...	sintilimab	18 Years - 75 Years	Sichuan University
Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors	NCT03982173	Metastatic Colo... Triple Negative... Prostate Adenoc... Stomach Adenoca... Esophageal Aden...	Tremelimumab Durvalumab	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy	NCT06362070	Gastric Cancer Gastrointestina... Neoplasms Gastric Diffuse... Gastric Neoplas... Stomach Adenoca...	DaVinci® Surgic... Hugo™ RAS Syste... Versius® Roboti...	18 Years - 80 Years	Azienda Ospedaliera Universitaria Integrata Verona
General Tissue Response Classification System After Chemotherapy	NCT03791268	Stomach Adenoca...	Gastric cancer ...	18 Years - 75 Years	West China Hospital
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy	NCT06362070	Gastric Cancer Gastrointestina... Neoplasms Gastric Diffuse... Gastric Neoplas... Stomach Adenoca...	DaVinci® Surgic... Hugo™ RAS Syste... Versius® Roboti...	18 Years - 80 Years	Azienda Ospedaliera Universitaria Integrata Verona
General Tissue Response Classification System After Chemotherapy	NCT03791268	Stomach Adenoca...	Gastric cancer ...	18 Years - 75 Years	West China Hospital

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