Clinical trial · Interventional
Apatinib Plus XELOX as Neoadjuvant Therapy in Locally Advanced Gastric Cancer
Apatinib Plus XELOX Regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer Patients With Lymph Node Metastasis
NCT03229096CI-TRIAL-00039253unknownPhase 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)
Apatinib plus XELOX regime as Neoadjuvant Therapy in Locally Advanced Gastric Cancer PatientsWith lymph node metastasis
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib plus XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib plus XELOX
- description
- Patients will be given the perioperative chemotherapy of Apatinib plus XELOX once recruited
- interventionNames
- Drug: Apatinib plus XELOX
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 3 months
- description
- Both CR and PR according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1
Secondary outcomes (4)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients, age ≥18 years. 2. Karnofsky score 70%. 3. Histologically confirmed adenocarcinoma of gastric cancer with Lauren classification Clinically diagnosed stage T2-T4aN+M0 according to CT/MRI scan. 4. At least one measurable and evaluable disease based on response evaluation criteria in solid tumors (RECIST v1.1), that is one or more perigastric lymph note were greater than or equal to 1.5cm in diameter. 5. Laparoscopic exploration confirms no peritoneal metastasis and negative peritoneal lavage. 6. Physical condition and adequate organ function to ensure the success of abdominal surgery. 7. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥8g/dL. Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.Adequate renal function: Serum creatinine ≤ 1 x ULN, and serum albumin≥30g/L. 8. Life expectancy of more than 5 years without serious concomitant diseases. 9. Written (signed) informed consent. 10. Able to comply with study and follow-up procedures. 11. Consent to provide tissue sample. Exclusion Criteria: 1. Pregnant or lactating women. 2. pregnancy tests before entering the group (in serum) of the childbearing age women were positive, or no pregnancy tests. 3. patients with distant metastases or local unresectable factors. 4. tumor stage considered as cT1 by imaging or ultrasound gastroscopy. 5. Patients who received prior anti-tumor therapy including cytotoxic chemotherapy, radiotherapy, hormonal therapy and immunotherapy. 6. History of other malignancies within the last 5 years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix. 7. History of significant neurological or mental disorder, including seizures or dementia, which may interfere compliance and sign of consent inform. 8. Unstable, persistent cardiac disease despite medicinal treatment; myocardial infarction within 12 months before the start of the trial. 9. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management. 10. Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug absorption. 11. Patients who experienced GI bleeding within two weeks, or with high risk of bleeding. 12. Patients with symptomatic peripheral neuropathy NCI CTC version\> 1.0 grade, except only the deficiency of Deep tendon reflex. 13. Organ transplant patient need immunosuppression treatment. 14. Active or uncontrolled severe infection or other severe and /or uncontrolled diseases 15. Patients with moderate or severe chronic kidney disease estimated glomerular filtration rate≤50 ml/min or serum creatinine ≥the upper limit of normal(ULN), 16. deficiency of dihydropyrimidine dehydrogenase (DPD) 17. Allergy to the drugs in this protocol 18. Less than 4 weeks from the last clinical trial.
References
Publications (18)
- BACKGROUNDSasako M, Sano T, Yamamoto S, Kurokawa Y, Nashimoto A, Kurita A, Hiratsuka M, Tsujinaka T, Kinoshita T, Arai K, Yamamura Y, Okajima K; Japan Clinical Oncology Group. D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer. N Engl J Med. 2008 Jul 31;359(5):453-62. doi: 10.1056/NEJMoa0707035. PMID 18669424
- BACKGROUNDSongun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19. PMID 20409751
- BACKGROUNDFujitani K, Yang HK, Mizusawa J, Kim YW, Terashima M, Han SU, Iwasaki Y, Hyung WJ, Takagane A, Park DJ, Yoshikawa T, Hahn S, Nakamura K, Park CH, Kurokawa Y, Bang YJ, Park BJ, Sasako M, Tsujinaka T; REGATTA study investigators. Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial. Lancet Oncol. 2016 Mar;17(3):309-318. doi: 10.1016/S1470-2045(15)00553-7. Epub 2016 Jan 26. PMID 26822397
- BACKGROUNDSano T, Coit DG, Kim HH, Roviello F, Kassab P, Wittekind C, Yamamoto Y, Ohashi Y. Proposal of a new stage grouping of gastric cancer for TNM classification: International Gastric Cancer Association staging project. Gastric Cancer. 2017 Mar;20(2):217-225. doi: 10.1007/s10120-016-0601-9. Epub 2016 Feb 20. PMID 26897166
- BACKGROUNDYoshikawa T, Sasako M, Yamamoto S, Sano T, Imamura H, Fujitani K, Oshita H, Ito S, Kawashima Y, Fukushima N. Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer. Br J Surg. 2009 Sep;96(9):1015-22. doi: 10.1002/bjs.6665. PMID 19644974
- BACKGROUNDCunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.