Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine, Cisplatin, Sorafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- XP+sorafenib
- interventionNames
- Drug: Capecitabine, Cisplatin, Sorafenib
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- XP
- interventionNames
- Drug: Capecitabine, Cisplatin, Sorafenib
Primary outcomes (2)
- measure
- Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
- timeFrame
- 28weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available