Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Neoplasm Metastasis

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Oxaliplatin

Capecitabine

Antimetabolites

Antineoplastic Agents, Immunological

Patient takes Trastuzumab (initial dose 8 mg/kg and a maintenance dose 6 mg/kg) anda oxaliplatin (dose 130mg/m2) during the first day os cycle and them Capecitabine (dose 2000 mg/m2)during 14 days in cycle of 21 days.

Trastuzumab: 8 mg/kg day 1 followed by 6 mg/kg every 3 weeks (i.v.)

Capecitabine: 1000 mg/m2/12h/days 1 - 14 every 3 weeks (v.o.)

Oxaliplatin: 130 mg/m2 in 2 h, day 1 / (i.v.) /every 3 weeks

Fernando Rivera NA, Doctor

The objective of the study is assess the efficacy and safety of Trastuzumab in combination with Capecitabine+Oxaliplatin as first-line treatment of patients with advanced or metastatic gastric cancer or gastro-esophageal junction, (HER2)-positive.

Gastric cancer worldwide is the second tumor incidence (10%). There are significant geographical differences in Spain with an incidence of 15 cases/100,000 per year. Although the incidence and mortality of gastric cancer (GC) have experienced a marked reduction in the past 40 years, this disease remains a leading cause of cancer-related mortality, accounting for more than 870,000 deaths worldwide in the year 2000.

Gastric cancer has a high mortality rate because usually diagnosed when in advanced stage and in many cases has a high relapse rate. Advanced gastric cancer cases are considered to be diagnosed with unresectable disease, either by having locally advanced disease (30% of cases at diagnosis), or having metastatic disease (another 30%) and patients with relapses (60% of resected). Thus, overall around 84% of patients with gastric cancer will have advanced disease.

The only curative treatment so far is surgery. Thanks to early detection and implementation of appropriate surgical techniques, survival has improved in some countries such as Japan and Korea, being the rate of 5-year survival of 47%Over the years, a large number of studies with a single agent chemotherapy has been shown that gastric cancer is a relatively sensitive to chemotherapy. Based on these observations, the trend was the investigation of the combination of chemotherapy agents.

Based on these results FDA and EMEA has approved capecitabine in the treatment of advance gastric cancer combined with platinum.

Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive

Phase II Study to Assess the Efficacy and Safety of Trastuzumab in Combination With Xelox as First-line Treatment of Patients With Advanced or Metastatic Gastric Cancer or Gastro-esophageal Junction, (HER2)-Positive.

Overall survival defined as the time from start of treatment until the patient's death

Progression free survival defined as time from start of treatment until date of progression were observed according to RECIST 1.1

Time to progression defined as time elapsed since the beginning of treatment until disease progression

Duration of response defined as the time since the objective complete or partial response until there is disease progression

Time to response, defined as the time from initiation of treatment until objective complete or partial response

Fundación para el Progreso de la Oncología en Cantabria

Docetaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Single-center, open-label, prospective, single-arm, phase I-II study

The study medication will be administered every 3 weeks for a maximum of 8cycles. A study medication will be given to the patients.

* Docetaxel (-1 to 3 level)mg/m2 IV(D1) every 21 days (-1 level: 40, 1 level: 60, 2 level: 80, 3 level: 100)
* Xeloda 937.5 mg/m2/ day PO, twice a day(D1-D14) every 21 days
* Cisplatin 60mg/m2 IV (D1) every 21 days

Min-Hee Ryu, MD

A maximum of 8 cycles of chemotherapy will be administered. Depending on patients' tolerability, 8 cycles of chemotherapy will be given to the patients.

Single-center, open-label, prospective, single-arm, phase I-II study

About 37 patients (Phase I 18, Phase II 31 (including 12 patients from Phase I)

Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer

A Phase I-II Study of Systemic Capecitabine, Cisplatin and Intraperitoneal Docetaxel (XPID) in Patients With Advanced Stomach Cancer With Peritoneal Seeding

Phase I Study

- Maximum tolerated dose of Intraperitoneal Docetaxel

Phase II Study

* Progression-free survival rate at 6 months
* response rate, time to progression, overall survival

Asan Medical Center

Associate Professor

Paclitaxel

Albumin-Bound Paclitaxel

chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress

Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy

40-60mg/m\^2 bid, days 1-14, oral，every 3 weeks.

100mg/m\^2 days 1，intravenous infusion, every 3 weeks.

oxaliplatin

hyperthermic intraperitoneal chemoperfusion

Hyperthermic Intraperitoneal

Kuan Wang

This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world

Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer

Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer

time from enrollment to disease progression or death

measured by recording the subjects' Adverse Events according to CTCAE 4.03

Harbin Medical University

Professor

Anti-Infective Agents

Irinotecan

Epirubicin

Topoisomerase I Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment \* 6 cycles as the second line chemoregime for advanced gastric cancer

second line chemoregime for advanced gastric cancer

Yueyin Pan, MD

Hu Liu, MD

This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.

The main purposes: to determine the progression-free survival (PFS) and overall survival (OS) of gastric cancer patients given irinotecan + epirubicin as second-line treatment, who are at Stage IV with disease progressed or recurred after first-line chemotherapy failed, ,

The Secondary purposes: to determine disease control rate (Disease Control Rate, DCR), the objective response rate (Object Response rate, ORR) and the Quality of life (Quality Of Life, QOL)

The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer

Evaluation progression-free survival (PFS) and overall survival (OS)

RECIST(Response Evaluation Criteria In Solid Tumors)1.1:

1. Complete response (CR)
2. Partial response (PR)
3. Stable disease(SD) and progression disease(PD)
4. CR + PR is efficient.

Anhui Medical University

Camrelizumab: 200 mg, intravenous infusion, d1, q3w;

Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w;

S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w;

Camrelizumab: 200 mg, intravenous infusion, d1, q3w;

Nab-paclitaxel: 130 mg/m2 intraperitoneal and 130 mg/m2 intravenously, d1, q3w;

S-1: calculated based on body surface area Dosage, twice a day, orally, d1-d14, q3w;

The dosage can be adjusted according to the protocol according to the adverse reactions of subjects. Subjects will continue to take medication until completion of the prescribed course of treatment, disease progression, toxicity intolerance, withdrawal of Informed Consent Form, or termination in the investigator's judgment.

Camrelizumab; Nab-paclitaxel; S-1

Li Xiao, Phd

The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.

The incidence of gastric cancer in China is high. Although the guidelines have recommended standard first and second-line chemotherapy, the survival rate of patients with advanced gastric cancer with peritoneal metastasis is still low.Nab-paclitaxel is a taxane drug, because of its binding to albumin, it does not need pretreatment before infusion, which is convenient for infusion, and has great application prospects in the treatment of advanced gastric cancer. There are positive expectations regarding the safety and efficacy of the combination. With the deepening of the understanding of the body's immune system and the rapid development of biotechnology, immunotherapy has become an important means of tumor treatment, and occupies an increasingly important position in the comprehensive tumor treatment system. At the same time, a number of studies have confirmed that camrelizumab combined with chemotherapy has a better therapeutic effect in gastric cancer, and the safety is tolerable.

In summary, how to improve the short-term and long-term efficacy of gastric cancer with peritoneal metastasis, while improving patient tolerance as much as possible and reducing adverse reactions, is an urgent problem to be solved. The purpose of this study was to evaluate the efficacy of camrelizumab combined with nab-paclitaxel intraperitoneal infusion, intravenous chemotherapy and S-1 in the treatment of advanced gastric cancer with peritoneal metastasis, so as to preliminarily explore the feasibility of the three-drug combination regimen in patients with gastric cancer with peritoneal metastasis and safety, and strive to maximize the benefits of different groups of people.

Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis：Single-arm, Prospective Clinical Study

Defined as the time from the date of informed consent to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.

Defined as the time from the date of informed consent until to the date of death, regardless of the cause of death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Trastuzumab, Capecitabine y Oxaliplatine as Treatment Gastric Cancer Metastatic (HER2)Positive	NCT01503983	Stage IV Gastri...	Trastuzumab Capecitabine Oxaliplatin	18 Years -	Fundación para el Progreso de la Oncología en Cantabria
Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer	NCT01525771	Stage IV Gastri...	Docetaxel	18 Years -	Asan Medical Center
Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer	NCT03237507	Stage IV Gastri...	S-1 oxaliplatin Hyperthermic In... Paclitaxel	18 Years -	Harbin Medical University
Safety Study of Combined Systemic and Intraperitoneal Chemotherapy to Treat Stomach Cancer	NCT01525771	Stage IV Gastri...	Docetaxel	18 Years -	Asan Medical Center
The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer	NCT01964027	Stage IV Gastri...	second line che...	18 Years - 75 Years	Anhui Medical University
Camrelizumab Combined With Intraperitoneal Infusion of Nab-paclitaxel, Intravenous Chemotherapy and S-1 in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis：Single-arm, Prospective Clinical Study	NCT05441254	Stage IV Gastri...	Camrelizumab; N...	18 Years - 75 Years	Zhongshan Hospital Xiamen University

Spots Global Cancer Trial Database for stage iv gastric cancer with metastasis