Clinical trial · Interventional
Phase II Study of Neoadjuvant XELOX + Lapatinib in HER2(+) Gastric Cancer Patients With Liver Metastasis
NCT02015169CI-TRIAL-00031213completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
We planned this study to investigate the efficacy and safety of XELOX (capecitabine and oxaliplatin) plus lapatinib treatment in HER2-positive gastric cancer patients with liver metastasis.
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 |
|---|---|---|---|
| HER2-positive Gastric Cancer Patients With Liver Metastasis | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- XELOX+lapatinib
- description
- D1 Oxaliplatin130mg/m2 + D5W 500ml MIV over 2hrs D1-D14 Capecitabine 850mg/m2 p.o bid D1 \~ Lapatinib 1250 mg qd dailiy
- interventionNames
- Drug: Lapatinib
Primary outcomes (1)
- measure
- complete resection rate (R0 resection rate) (defined as no macroscopic or microscopic residual tumor).
- timeFrame
- after surgery, up to 3weeks
Secondary outcomes (5)
- measure
- response rate based on RECIST 1.1
- timeFrame
- every 3 cycles, up to 24weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven gastric cancer with metastatic lesion(s) that is (are) unresectable * locally advanced gastric cancer that are NOT resectable * distant metastases limited to abdominal lymph node, liver only :Patients with liver metastasis : Number of liver metastasis between 2 and 5 or maximal diameter should be under 5 cm (2 = liver mets = 5 or maximal diameter = 5cm) No LN metastasis within group 3 and no bulky N2 metastasis Clinically no distant metastasis (lung metastasis, mediastinal LN metastasis, neck LN metastasis, bone metastasis, brain metastasis, and peritoneal seeding in abdominal and pelvis CT; in cases of suspicious peritoneal seeding in imaging without any evidence of ascites and/or peritoneal enhancement will be allowed to enter the study based on investigators' decision) * chemo-naïve (adjuvant treatment will be allowed if the last date of treatment is ≥ 6 months from the study entry date 2. Age ≥ 18 3. ECOG performance 0 - 1 4. Adequate organ function (AST and ALT ≤2x upper limit of normal, bilirubin ≤1.5 x upper limit of normal, and creatinine \< 1.5x upper limit of normal, platelet \> 100,000/ul, absolute neutrophil count ≥ 1,500/ul) 5. At least one measurable lesion by RECIST 1.1 criteria 6. HER 2 (+) by HercepTest(IHC 3+ alone, or IHC 2+ with FISH amplification) 7. Written informed consent Exclusion Criteria: 1. Prior therapy for metastatic disease 2. Pregnant or lactating women 3. Uncontrolled medical illnesses including medically uncontrolled infection, uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within 6 months 4. Any comorbidities which are not suitable for general anesthesia and surgical resection 5. Distant metastases other than liver or abdominal lymph nodes (As outlined in inclusion criteria, and peritoneal seeding in abdominal and pelvis CT; in cases of suspicious peritoneal seeding in imaging without any evidence of ascites and/or peritoneal enhancement will be allowed to enter the study based on investigators' decision) 6. Known immediate or delayed hypersensitivity reaction to lapatinib ,capecitabine, oxaliplatin or any other platinum compounds, any recipients. 8\) Subjects with DPD deficiency 9) Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) 10) Pre-existing hand and foot syndrome and peripheral neuropathy of grade 2 or greater 11) Subjects unsuitable to resection or general anesthesia
References
Publications (0)
Data not yet available
No reference posted for this study.