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COMPLETEDPHASE1/PHASE2

Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC): Sorafenib+XP

A Phase I-II Study of Sorafenib (Nexavar®) in Combination With Capecitabine and Cisplatin (XP) in Patients With Advanced Gastric Cancer

NCT00565370•Asan Medical Center

View on ClinicalTrials.gov

Summary

There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Having given signed written informed consent
•Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred
•No history of chemotherapy or radiation
•Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
•Age 18-75 years
•Estimated life expectancy of more than 3 months
•Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•Adequate bone marrow function (absolute neutrophil count \> 1,500/µL, platelets \> 100,000/µL, hemoglobin \> 8g/dl),
•Adequate kidney function (creatinine clearance \> 60 ml/min)
•Adequate liver function (bilirubin \< 2.0 mg/dL, transaminases levels \< 3 times the upper normal limit \[5 times for patients with liver metastasis\])

Exclusion Criteria

•Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start
•Presence of central nervous system metastasis
•Obvious peritoneal seeding or bowel obstruction
•Evidence of serious gastrointestinal bleeding
•Peripheral neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Event version 3.0 \> Grade I)
•History of significant neurologic or psychiatric disorders
•Pregnant or lactating women, women of childbearing potential not employing adequate contraception
•Other serious illness or medical conditions
•Known allergy to study drugs

Locations (1)

Asan Medical Center

Seoul, South Korea

Key Dates

Start Date

November 1, 2007

Primary Completion Date

December 1, 2009

Completion Date

December 1, 2009

Last Updated

January 18, 2020

Enrollment

ACTUAL participants

Conditions

Advanced Gastric Cancer

Interventions

Capecitabine, Cisplatin, Sorafenib

DRUG

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers

NCT07259226

Advanced Breast CancerAdvanced Gastric Cancer+2 more

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RECRUITINGPHASE2

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

NCT07102901

Advanced Gastric CancerMetastatic Gastric Cancer+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC): Sorafenib+XP

Inclusion Criteria

Exclusion Criteria

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers

Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

First-Line and Neoadjuvant Immunotherapy for Gastric Cancer

Machine Learning-driven Noninvasive Screening of Transcriptomics Liquid Biopsies for Early Diagnosis of Occult Peritoneal Metastases in Locally Advanced Gastric Cancer

SHR-A1811 for Subjects With Her2-positive Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on or After First-line Anti-HER2 Therapy-containing Regimen

Evaluation of Pressurized Intraperitoneal Aerosol Chemotherapy With VRT106 Versus PIPAC in Patients With Advanced Gastric Cancer and PeritonealMetastasis: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial