Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Adenocarcinoma

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Cisplatin

Drug: S-1:

S-1 will be administered at 40 mg/m2 orally, twice daily (80 mg/m2 total daily dose) on Days 1 through 21 of each 35-day treatment cycle.

Drug: Cisplatin:

Cisplatin will be administered at 60 mg/m2 by intravenous infusion on Day 8 of each 35-day treatment cycle.

Drug: Capecitabine:

Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.

Drug: Cisplatin:

Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.

Akira Tsuburaya

The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.

XP and SP are either standard treatment for advanced gastric cancer. The aim of this study is to elucidate the efficacy and safety of Capecitabine/Cisplatin and S-1/Cisplatin for first-line treatment of Advanced Gastric Cancer.

XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer

A Randomized Phase II Trial Comparing Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer (XParTS II)

Epidemiological and Clinical Research Information Network

Neoplasm Metastasis

Paclitaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Tubulin Modulators

Antimitotic Agents

Paclitaxel will be administered intraperitoneally at 40mg/m2 on Days 1 and 8 in a 21-day cycle in patients receiving intravenous oxaliplatin 100mg/m2 on Day 1 and capecitabine 1000mg/m2 twice daily on Days 1-14.

Each treatment cycle will consist of 21 days, with 14 days on treatment and 7 days off-treatment. Oxaliplatin will be administered intravenously (on Day 1 of each cycle). Paclitaxel will be administered intra-abdominally on Day 1 and Day 8 of each cycle. In particular, a needle will be inserted into the intraperitoneal injection port for normal saline to be injected intra-abdominally over one hour, followed by paclitaxel chemotherapy over a further one hour. Capecitabine will be taken by mouth from Day 1 to 14 of each cycle.

IP Paclitaxel

Wei Peng Yong, MBBS

Robert Lim, MBBS

Maricel Cordero

This is a single arm phase 2 trial evaluating the efficacy and tolerability of intraperitoneal paclitaxel with oxaliplatin and capecitabine in advanced gastric cancer patients with peritoneal metastasis and/or cancer cells on peritoneal cytology. Twenty patients will be recruited into the study for an estimated period of two years. Paclitaxel will be administered intraperitoneally at 40mg/m2 on Day 1 and 8 in patients receiving standard intravenous oxaliplatin 130mg/m2 on Day 1 and capecitabine 1000mg/m2 on day 1-14. The study hypothesizes that the addition of intraperitoneal paclitaxel with chemotherapy will improve treatment efficacy.

The median survival of patients with unresectable gastric cancer treated with systemic chemotherapy is about 12 months. In patients with histologically proven unresectable or recurrent gastric cancer limited to the peritoneum and/or cancer cells in peritoneal cytology, the combination of i.p. paclitaxel with systemic chemotherapy reported a median survival time of 23.6 months. The peritoneal cytology turned negative for 86% of patients. In an updated report, gastrectomy was performed on 52 patients after disappearance or obvious shrinkage of peritoneal metastasis. In this cohort, the median survival time (MST) was 34.9 months. A phase III trial (PHOENIX-GC trial (Phase III study of S-1 plus intravenous and intraperitoneal paclitaxel versus S-1 plus cisplatin for gastric cancer with peritoneal metastasis )) comparing intraperitoneal(IP) regimen with systemic chemotherapy versus systemic therapy alone is currently opened for recruitment in Japan.

The multidisciplinary treatment combining IP-containing chemotherapy and surgery was found to be safe and effective for gastric cancer patients with peritoneal metastasis. A phase I study combining i.p. paclitaxel with oxaliplatin and S-1, found no dose limiting toxicity in all dose levels. Grade 3 neutropenia was observed in one patient at recommended phase 2 dose (RP2D) of i.p. paclitaxel of 40 mg/m2. In addition, grade 2 non-hematological toxicities observed were anorexia (n=6/12), fatigue (n=4/12) and nausea (n=2/12).

Both S-1 and capecitabine are orally available fluoropyrimidine. When combined with oxaliplatin, both S-1 and capecitabine were found to be equally active and well tolerated in advanced gastric cancer patients. As S-1 is not yet widely available worldwide, the combination of capecitabine and a platinum chemotherapy is still one of the most commonly adopted chemotherapy regimen for patients with advanced gastric cancer. In this study, we intend to assess the efficacy and feasibility of combining weekly i.p. paclitaxel with oxaliplatin and capecitabine.

Feasibility Study of Intraperitoneal Paclitaxel

Feasibility Study of Intraperitoneal Paclitaxel With Oxaliplatin and Capecitabine in Patients With Advanced Gastric Cancer

The primary end point is 1-year survival because most patients may not have measurable disease, hence response rate and progression free survival are less easy to assess.

Toxicity will be monitored 3-weekly and graded according to the National Cancer Institute -Common Terminology Criteria for Adverse Events version 4.0.

National University Hospital, Singapore

Dr. Yong Wei Peng

Esophageal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Micronutrients

Hematinics

Vitamins

Docetaxel

Trastuzumab

Leucovorin

Fluorouracil

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Drug Dose (mg/m2) Schedule

Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).

Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17

\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg

Treatment for Her2 Positive Participants

Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Trastuzumab Administered on an every 2 week dosing schedule. Initial loading dose of 6 mg/kg over 90 minutes, followed by trastuzumab 4 mg/kg every 2 weeks over 30 minutes.

Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)

Docetaxel, Leucovorin, Fluorouracil, Cisplatin

Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17

\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg

Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.

Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen

Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab

Yelena Janjigian, MD

Chemotherapy given together is a standard way to treat your cancer. One standard treatment includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original combination of these three drugs can cause many side effects. This study is being done to find out if these three drugs can be given at lower doses more often, with fewer side effects and still maintain the same benefit as the standard way of giving this three drug combination. If your tumor overexpresses a protein called Her2, you are also eligible to receive trastuzumab with chemotherapy. Trastuzumab is a medicine that has been approved by the US Food and Drug Administration for the treatment of Her2 positive breast cancer. Trastuzumab is now also a standard treatment in combination with chemotherapy for the treatment of Her2 positive stomach cancer. If your tumor is Her2 positive, you would receive the modified administration schedule of docetaxel, cisplatin, and fluorouracil with trastuzumab.

Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

A Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Patients With Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate

Sanofi

Roche-Genentech

City of Hope National Medical Center

Piedmont Hospital Research Institute

Medical College of Wisconsin

Queens Health Network

Weill Medical College of Cornell University

Memorial Cancer Institute, Florida

University of Pittsburgh

Long Island Jewish Medical Center

Nebraska Cancer Specialists Methodist Estabrook Cancer Center

Memorial Sloan Kettering Cancer Center

Drug Dose (mg/m2) Schedule

Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 mg/m2/d daily x 2 days Cisplatin 40 Day 2 OR 3 IVPB (30 min) Arm A is repeated every 2 weeks, and a cycle will be considered 6 weeks (eg 3 treatments).

Docetaxel, Leucovorin, Fluorouracil, Cisplatin: Drug Dose (mg/m2) Schedule Docetaxel 40 Day 1 IVPB (60 min) Leucovorin 400 Day 1 IVPB (30 min) Fluorouracil 400 IVP day 1 Fluorouracil 1000 IVCI x 48 hours Cisplatin 40 Day 2 OR 3 IVPB (30 min)

Arm A, - Modified DCF

Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17 \* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg

Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen: Drug Dose (mg/m2) Schedule Docetaxel 75 Day 1 IVPB (60 min) Cisplatin 75 Day 1 IVPB (60 min) Fluorouracil 750 IVCI daily x 5 days Neulasta 6 mg subcut on d 8, 9, or 10 or Neupogen 300 or 480 mcg\* subcut x 7 d 10-17

\* 300 mcg for weight \< 60 kg, 480 mcg for weight \> 60 kg

Arm B is repeated every 3 weeks, and a cycle will be considered every 6 weeks (eg 2 treatments). Tumor assessments will be performed following the completion of every cycle for the first 6 cycles, and then every 2 cycles thereafter.

ARM B - Parent DCF With G-CSF

Arm C - Modified DCF+ Trastuzumab

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Yelena Janjigian, MD

6 Month Progression Free Survival (PFS)

Overall Survival

Overall Study

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

1. Apatinib :

   A starting dose of apatinib was administered 500 mg daily on days 1 through 21 of each 3-week cycle.
2. Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle.
3. S-1:40mg，bid，d1-14，po，in a 21 day cycle.

Apatinib :A starting dose of apatinib was administered 500 mg daily

Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle

S-1:40mg，bid，d1-14，po，in a 21 day cycle.

Hongqing Xi, Master

Lin Chen, Master

Lin Chen

This is a Prospective，Single-center，Single-arm，Open-label exploratory clinical trial evaluating the efficacy and safety of Conversion Surgery for Apatinib plus SOX for patients with unresectable gastric cancer.

Gastric cancer is the second most common cause of cancer-related deaths worldwide, and surgical resection during the early stage has improved treatment outcomes.However, many patients are diagnosed with unresectable advanced or metastatic stage disease losing the radical surgery opportunity. Systemic chemotherapy is the leading treatment that prolongs survival times for such patients.

Approximate 20 patients with unresectable gastric cancer will be enrolled in this study,the investigators will evaluate the efficacy and security of Apatinib + SOX(oxaliplatin+S-1) for unresectable gastric cancer.

The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer

The Exploratory Study of Conversion Surgery for Apatinib in Combination With Oxaliplatin/S-1(SOX) for Patients With Unresectable Gastric Cancer

Chinese PLA General Hospital

Director of the General Surgery Department, Chinese PLA General Hospital

Immunomodulating Agents

Pengfei Yu, MD, PhD

Cheng Xiangdong, MD

Xiangdong Cheng, MD, PhD

This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.

A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer

A Retrospective Study of Sintilimab Combined With Chemotherapy in Conversion Therapy of Unresectable Locally Advanced or Stage IV Gastric Cancer/Gastroesophageal Junction Carcinoma

Defined as no residue under the microscope after resection

MPR is defined as less than 10% residual tumor after neoadjuvant therapy

ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment

Innovent Biologics, Inc.

Zhejiang Cancer Hospital

Systemic Chemotherapy + Oral Chemotherapy Group

Arterial catheter infusion chemotherapy plus oral chemotherapy group

Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group

Arterial catheter infusion chemotherapy

Arterial catheter infusion Sodium Bicarbonate

Sodium Bicarbonate

Systemic Chemotherapy

Oral Chemotherapy

Ming Chao

Min Chao

This project intends to compare the clinical effects and side effects of three kinds of treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. It is clear that intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate is not suitable for the treatment of unresectable gastric cancer. The clinical practice value of resection of gastric cancer can provide high quality evidence-based medical basis for the treatment guidelines of advanced gastric cancer, and explore a new clinical technology with exact curative effect and higher safety.

Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer

A Randomized Controlled Trial for Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate and Systemic Chemotherapy for Unresectable Gastric Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer	NCT01406249	Gastric Cancer	SP XP	20 Years - 74 Years	Epidemiological and Clinical Research Information Network
Feasibility Study of Intraperitoneal Paclitaxel	NCT01739894	Gastric Cancer	IP Paclitaxel	21 Years - 99 Years	National University Hospital, Singapore
XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer	NCT01406249	Gastric Cancer	SP XP	20 Years - 74 Years	Epidemiological and Clinical Research Information Network
Feasibility Study of Intraperitoneal Paclitaxel	NCT01739894	Gastric Cancer	IP Paclitaxel	21 Years - 99 Years	National University Hospital, Singapore
Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma	NCT00515411	Gastroesophagea... Gastric Cancer	Docetaxel, Leuc... Docetaxel, Cisp... Docetaxel, Leuk...	18 Years -	Memorial Sloan Kettering Cancer Center
The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer	NCT03007446	Gastric Cancer	Apatinib Oxaliplatin S-1	18 Years - 70 Years	Chinese PLA General Hospital
Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma	NCT00515411	Gastroesophagea... Gastric Cancer	Docetaxel, Leuc... Docetaxel, Cisp... Docetaxel, Leuk...	18 Years -	Memorial Sloan Kettering Cancer Center
A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer	NCT05385809	Unresectable Ga...		18 Years - 75 Years	Zhejiang Cancer Hospital
Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer	NCT03822130	Successful Conv... Unresectable Ga...	Arterial cathet... Sodium Bicarbon... Systemic Chemot... Oral Chemothera...	18 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
The Study of Conversion Surgery for Apatinib in Combination With SOX for Patients With Unresectable Gastric Cancer	NCT03007446	Gastric Cancer	Apatinib Oxaliplatin S-1	18 Years - 70 Years	Chinese PLA General Hospital

Spots Global Cancer Trial Database for unresectable gastric cancer