关于胃癌分子靶向治疗的临床研究

1. A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer（recruiting participants）

Purpose

This 2 arm study will compare the efficacy and safety of Avastin versus placebo, in combination with Xeloda and cisplatin, in patients who have received no prior treatment for advanced or metastatic gastric cancer.

Patients will be randomized to receive either Avastin 7.5mg/kg iv or placebo iv, in combination with Xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle, and cisplatin 80mg/m2 every 3 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Condition Gastric Cancer Intervention Drug: bevacizumab [Avastin] Drug: capecitabine [Xeloda] Drug: cisplatin Drug: Placebo Phase Phase III

Study Type:

Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator),

Parallel Assignment, Safety/Efficacy Study Official Title:

A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Chinese Patients With Advanced Gastric Cancer.

2. Pre-Operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma

This study is currently recruiting participants.

Verified by Memorial Sloan-Kettering Cancer Center, July 2009

First Received: August 15, 2008 Last Updated: July 1, 2009 History of Changes Sponsors and Center Collaborators: Memorial Sloan-Kettering Cancer Genentech Information provided by: Memorial Sloan-Kettering Cancer Center ClinicalTrials.gov Identifier: NCT00737438 Purpose

This study is being done to find out how effective a new treatment strategy is on your cancer. In this strategy, the response your tumor has to the first cycle of therapy will help select the next treatments. We also will find out the effects, both good and/or bad, a drug called bevacizumab has on you and your tumor when given with chemotherapy. Condition Esophageal Cancer Gastric Cancer Study Type:

Intervention Phase Drug: epirubicin, cisplatin, capecitabine, bevacizumab, Phasdocetaxel and irinotecan e II Interventional

Study Design: Treatment, Open Label, Single Group Assignment, Efficacy

Study

Official Title:

A Phase II Study of Pre-Operative Chemotherapy Plus Bevacizumab With Early Salvage Therapy Based on PET Assessment of Response in Patients With Locally Advanced But Resectable Gastric and GEJ Adenocarcinoma

3.Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer

This study is ongoing, but not recruiting participants.

First Received: August 15, 2005 Last Updated: May 12, 2009 History of Changes Dana-Farber Cancer Institute Bristol-Myers Squibb Sponsors and Collaborators: Massachusetts General Hospital Beth Israel Deaconess Medical Center Information provided by: Dana-Farber Cancer Institute ClinicalTrials.gov Identifier: NCT00130689 Purpose

The purpose of this study is to determine the response rate of cetuximab in patients with advanced esophageal or gastric cancer.

The secondary purposes are to determine the safety and to evaluate the duration of response in patients treated with cetuximab.

Condition Esophageal Cancer Gastric Cancer Neoplasm Metastasis

Intervention Drug: Cetuximab Phase Phase II

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control,

Single Group Assignment, Safety/Efficacy Study Official Title:

A Phase II Trial of Cetuximab in Unresectable or Metastatic Esophageal and Gastric Carcinoma

4.Lapatinib（拉帕替尼）in Treating Patients With Locally Advanced or Metastatic Stomach Cancer

This study is ongoing, but not recruiting participants.

First Received: February 7, 2005 Last Updated: July 23, 2008 History of Changes Sponsors and Collaborators: Southwest Oncology Group National Cancer Institute (NCI) Information provided by: National Cancer Institute (NCI) ClinicalTrials.gov Identifier: NCT00103324 Purpose

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic stomach cancer.

Condition Gastric Cancer

Study Type:

Intervention Drug: lapatinib ditosylate Phase Phase II Interventional

Study Design: Treatment, Open Label

Official Title:

Phase II Study of GW572016 (NSC #727989) as First Line Therapy in Patients With Advanced or Metastatic Gastric Cancer

5. Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)

in Metastatic Esophageal and Gastric Cancer

This study is ongoing, but not recruiting participants.

First Received: October 31, 2006 Last Updated: December 5,

2008 History of Changes Dana-Farber Cancer Institute Brigham and Women's Hospital Sponsors and Collaborators: Massachusetts General Hospital Genentech Information provided by: Dana-Farber Cancer Institute ClinicalTrials.gov Identifier: NCT00394433 Purpose

The purpose of this research study is to determine if the combination of docetaxel, cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric cancer and how the cancer responds to this

combination. Bevacizumab is a new drug that is believed to stop the formation of new blood vessels that carry nutrients to tumors. Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin and

irinotecan are traditional chemotherapy agents that have been tested together in another clinical trial for esophageal and gastric cancer. Of the 40 patients on this trial, 60% of the patients showed a response of some kind and the regimen was well tolerated. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.

ClinicalTrials.gov Identifier: NCT00486954 Purpose EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is

designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in

patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel. Condition Advanced Gastric Cancer Gastric Cancer Study Type:

Intervention Drug: lapatinib oral tablets, paclitaxel infusion Phase Phase III Interventional

Study Design: Treatment, Randomized, Open Label, Single Group

Assignment Official Title:

A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone in the Second Line Treatment of ErbB2 Amplified Advanced Gastric Cancer

16. Selective COX-II Inhibitor as an Adjuvant Therapy

in

Patients

With

Resectable

Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: November 16,

2005 History of Changes

Sponsored by: Chinese University of Hong Kong Information provided by: Chinese University of Hong Kong ClinicalTrials.gov Identifier: NCT00164892 Purpose

The purpose of this study is to investigate the efficacy of selective COX-II inhibitor in patients with curative resection performed for locally advanced stomach cancer.

Condition Intervention Phase Cancer of Stomach Drug: Oral Vioxx (Rofecoxib) Phase III

Study Type:

Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control,

Parallel Assignment, Efficacy Study Official Title:

Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial

17. Study Of Axitinib In Combination With

Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer

This study is currently recruiting participants.

Verified by Pfizer, August 2009

First Received: February 11, 2009 Last Updated: August 9, 2009 History of Changes Sponsored by: Pfizer

Information provided by: Pfizer ClinicalTrials.gov Identifier: NCT00842244 Purpose

The purpose of this study is to determine the safe and tolerable dose of axitinib given together with cisplatin and capecitabine in patients with advanced

gastric cancer who have not received prior chemotherapy for their advanced cancer.

Condition Stomach Neoplasms Advanced Gastric Cancer

Study Type:

Intervention Drug: axitinib Drug: capecitabine Drug: cisplatin Phase Phase I Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group

Assignment, Safety/Efficacy Study Official Title:

A Phase 1 Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer

18. Erlotinib in Treating Patients With Locally

Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

This study has been completed.

First Received: March 8, 2002 Last Updated: July 23, 2008 History of Changes Sponsors and Collaborators: Southwest Oncology Group National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI) ClinicalTrials.gov Identifier: NCT00032123 Purpose

RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating

patients who have locally advanced or metastatic stomach cancer or cancer of the gastroesophageal junction.

Condition Intervention Phase Esophageal Cancer Drug: erlotinib hydrochloride Phase II Gastric Cancer

Study Type:

Interventional

Study Design: Treatment Official Title:

A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction

19. Docetaxel With or Without Vandetanib in

Treating Patients With Metastatic Stomach Cancer Cancer

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), July 2009

First Received: May 21, 2008 Last Updated: July 3, 2009 History of Changes

or Gastroesophageal Junction

Sponsors and Collaborators: Roswell Park Cancer Institute National Cancer Institute (NCI) Information provided by: National Cancer Institute (NCI) ClinicalTrials.gov Identifier: NCT00683787 Purpose RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in

different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given together with or without vandetanib.

PURPOSE: This randomized phase II trial is studying docetaxel to see how well it works compared with docetaxel given together with vandetanib in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.

Condition Gastric Cancer

Study Type:

Intervention Drug: docetaxel Drug: vandetanib Phase Phase II Interventional

Study Design: Treatment, Randomized, Open Label Official Title:

Multicenter Randomized Phase II Trial of Docetaxel

With/Without VANDETANIB for Advanced Gastroesophageal Cancer

. 20. Sorafenib Gastric Cancer Asian Phase I Study

This study is ongoing, but not recruiting participants.

First Received: April 17, 2008 Last Updated: July 3, 2009 History of Changes

Gastric Cancer

Study Type:

Interventional

Drug: cetuximab Phase II Study Design: Treatment, Open Label, Uncontrolled, Single Group

Assignment, Safety/Efficacy Study Official Title:

Phase II Study of Cetuximab (Erbitux?) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-Line Chemotherapy

25. Study Of Sunitinib In Combination With Cisplatin And

5-Fluorouracil In Patients With Advanced Gastric Cancer

This study is currently recruiting participants.

Verified by Pfizer, August 2009

First Received: November 8, 2007 Last Updated: August 14, 2009 History of Changes Sponsored by: Pfizer Information provided by: Pfizer ClinicalTrials.gov Identifier: NCT00555672 Purpose The purpose of this study is to determine the safe and tolerable dose of

sunitinib when given together with cisplatin and 5-fluorouracil in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.

Condition Stomach Neoplasms Intervention Drug: 5-fluorouracil Drug: cisplatin Drug: sunitinib malate Phase Phase I

Study Type:

Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group

Assignment, Safety/Efficacy Study Official Title:

A Phase I Study Of Sunitinib Malate In Combination With Cisplatin And 5-Fluorouracil In Patients With Advanced Gastric Cancer

26. Efficacy and Safety of Sunitinib in Metastatic Gastric

Cancer

This study is ongoing, but not recruiting participants.

First Received: December 11, 2006 Last Updated: February 9,

2009 History of Changes Sponsors and Mainz Collaborators: Johannes Gutenberg University Pfizer Information provided by: Johannes Gutenberg University Mainz ClinicalTrials.gov Identifier: NCT00411151 Purpose

This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer. Despite the efforts in front-line therapy, second-line protocols have not yet been established in randomized clinical trials for those patients. Although many patients are still in good performance status and present with low tumor burden after failure of first-line chemotherapy, they may clearly benefit from second-line treatment. Increasingly more metachronic metastatic patients are urging for new platinum-free therapeutic options due to the

fast-growing use of (neo-) adjuvant platin-based protocols. So far, only sparse data on chemotherapy are available after failure of platin-based protocols. Nearly only irinotecan-containing combinations have properly been analyzed, and produced excellent response rates and survival times of up to 30% and 7.6 months, respectively. However, irinotecan has not been approved yet for this indication. In addition, as irinotecan-containing regimens have been submitted for approval for first-line therapy, second-line regimens in

irinotecan-refractory patients have not been evaluated in any trial. Thus, there is an urgent need to establish new second-line treatment options for both, cisplatinum- or irinotecan-combination refractory patients with advanced or metastatic gastric cancer. Sunitinib inhibits the receptor tyrosine kinases (RTKs) involved in tumor proliferation and angiogenesis, specifically the

VEGFR, PDGFR, KIT, FLT-3, and RET. The VEGF pathway has been shown to be a significant factor in metastatic gastric cancer. In gastric carcinoma cells, VEGF ligands and its receptors are definitely involved in the process of tumor progression. KDR and FLT-1 are expressed widely and VEGF

stimulated KDR-positive tumor cell growth directly. The ligand VEGF-C has also been shown to be involved in progression of human gastric carcinoma, particularly via lymphangiogenesis. In addition, peritoneal metastases of some cancers such as gastric cancers were largely dependent on VEGF.

Therefore, patients with chemo-refractory metastatic gastric cancer might benefit from VEGFR inhibitory therapy with sunitinib.

Condition Intervention Phase Adenocarcinoma of Stomach Drug: Sunitinib-Malate Phase II Barrett Esophagus

Study Type:

Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled,

Single Group Assignment, Safety/Efficacy Study Official Title:

An Open-Label, Multicenter Phase II Trial of Sunitinib for Patients With Chemo-Refractory Metastatic Gastric Cancer

27.Epirubicin Cisplatin and Fluorouracil (FU) Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer

This study is currently recruiting participants.

Verified by Fudan University, May 2009

First Received: January 4, 2008 Last Updated: May 18, 2009 History of Changes Sponsored by: Fudan University Information provided by: Fudan University ClinicalTrials.gov Identifier: NCT00595972 Purpose

The purpose of this study is to evaluate the efficacy and tolerability of the ECF regimen (epirubicin, cisplatin and FU) combined with endostar-- a inhibitor of angiogenesis, in patients with advanced or metastatic gastric cancer (A/MGC).

Condition Gastric Cancer

Study Type:

Interventional

Intervention Drug: ECF-endostar Phase Phase II Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled,

Single Group Assignment, Efficacy Study Official Title:

Phase II Trial of Epirubicin Cisplatin and FU Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer

28.Study Of Sunitinib In Combination With

Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

This study is currently recruiting participants.

Verified by Pfizer, August 2009

First Received: November 6, 2007 Last Updated: August 14, 2009 History of Changes Sponsored by: Pfizer Information provided by: Pfizer ClinicalTrials.gov Identifier: NCT00555620 Purpose The purpose of the study is to determine the safe and tolerable doses of

sunitinib given together with either cisplatin and capecitabine or oxaliplatin and

capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer

Condition Stomach Neoplasms Intervention Drug: capecitabine Drug: oxaliplatin Drug: sunitinib malate Drug: cisplatin Phase Phase I

Study Type:

Interventional

Study Design: Treatment, Non-Randomized, Open Label, Parallel

Assignment, Safety/Efficacy Study Official Title:

A Phase 1 Study Of Sunitinib Malate In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

29.Study of Cetuximab to Treat Gastric Cancer (EFFI)

This study is currently recruiting participants.

Verified by Fudan University, June 2008

First Received: June 17, 2008 No Changes Posted

Sponsored by: Fudan University Information provided by: Fudan University ClinicalTrials.gov Identifier: NCT00699881 Purpose

The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy

Condition

Intervention Phase

Gastric Cancer

Study Type:

Interventional

Drug: cetuximab Phase II Study Design: Treatment, Open Label, Uncontrolled, Single Group

Assignment, Safety/Efficacy Study Official Title:

Phase II Study of Cetuximab (Erbitux?) in Combination With Modified FOLFIRI in Patients With Advanced Gastric Cancer Who Failed to First-Line Chemotherapy

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