Clinical trial · Interventional
T- XELOX in HER2-positive Stage III Gastric Cancer After D2 Gastrectomy
Trastuzumab Plus XELOX for HER2-positive Stage III Gastric Cancer After D2 Gastrectomy：Prospective Observational Study.
NCT02250209CI-TRIAL-00015707unknownPhase 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)
The objective of this study is to assess the clinical efficacy and safety of trastuzumab plus XELOX for treatment of HER2-positive Stage III Gastric Cancer After D2 Gastrectomy.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Trastuzumab,Capecitabine,Oxaliplatin
- description
- Patients receive eight 3-week cycles of oral capecitabine (800-1000 mg/m2 twice daily on days 1-14 of each cycle) ,intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) plus intravenous Trastuzumab (440mg on day 0 of each cycle). Number of cycle:capecitabine and oxaliplatin --8 cycles; Trastuzumab--14-16 cycles.
- interventionNames
- Drug: Trastuzumab
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- 3-year disease-free survival (DFS)
- timeFrame
- Measure at every 6 weeks (every 2 cycles)
- description
- Defined as the time from study treatment to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed informed-consent form. 2. Aged 18-80 years. 3. Had partial or total D2 gastrectomy and achieved R0 resection. 4. Histologically confirmed gastric or gastro-oesophageal junction adenocarcinoma，mucinous adenocarcinoma ，signet-ring cell carcinoma 5. Pathologic Stage III (IIIA-C). 6. HER2-positive: (IHC 3+ or IHC 2+ and FISH positive). 7. Patients must have received no preoperative chemotherapy or radiation therapy. 8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 . 9. Adequate liver/bone marrow function.Blood and biochemical parameters; 10. Compliant, and can be followed up regularly. Exclusion Criteria: 1. Patients who do not meet the Inclusion Criteria. 2. Pregnant or breast-feeding female, or not willing to take contraception measures during study. 3. Serious infection requiring antibiotics intervention during recruitment. 4. Allergic to study drug or with metabolism disorder. 5. Histologically confirmed small cell carcinoma of the stomach、gastric neuroendocrine carcinoma or others. 6. Uncontrolled brain metastasis or mental illness. 7. Organ transplant recipients (Autologous transplantation of bone marrow and peripheral stem cell transplantation included). 8. Congestive heart failure, uncontrolled cardiac arrhythmia, etc. 9. With severe hepatic/kidney/respirator/disease,or chronic disease like uncontrolled diabetes,hypertension,etc. 10. with other malignant tumors. 11. Can be followed up or obey protocol. 12. Ineligible by the discretion of the investigator.
References
Publications (12)
- RESULTBang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7. PMID 22226517
- RESULTGravalos C, Jimeno A. HER2 in gastric cancer: a new prognostic factor and a novel therapeutic target. Ann Oncol. 2008 Sep;19(9):1523-9. doi: 10.1093/annonc/mdn169. Epub 2008 Apr 25. PMID 18441328
- RESULTHofmann M, Stoss O, Shi D, Buttner R, van de Vijver M, Kim W, Ochiai A, Ruschoff J, Henkel T. Assessment of a HER2 scoring system for gastric cancer: results from a validation study. Histopathology. 2008 Jun;52(7):797-805. doi: 10.1111/j.1365-2559.2008.03028.x. Epub 2008 Apr 18. PMID 18422971
- RESULTTanner M, Hollmen M, Junttila TT, Kapanen AI, Tommola S, Soini Y, Helin H, Salo J, Joensuu H, Sihvo E, Elenius K, Isola J. Amplification of HER-2 in gastric carcinoma: association with Topoisomerase IIalpha gene amplification, intestinal type, poor prognosis and sensitivity to trastuzumab. Ann Oncol. 2005 Feb;16(2):273-8. doi: 10.1093/annonc/mdi064. PMID 15668283
- RESULTPiccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Lang I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Ruschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72. doi: 10.1056/NEJMoa052306. PMID 16236737
- RESULTSlamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101.