Clinical trial · Interventional
Clinical Study of Apatinib and XELOX Combination Regimen to Treat Colorectal Cancer Patients
A Phase II Clinical Trial Study on Apatinib and XELOX Combination Regimen in the First-line Treatment of End-stage Colorectal Cancer Patients
NCT02829385CI-TRIAL-00022960unknownPhase 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)
This study makes an observation over the objective response rate of Apatinib and XELOX combination regimen in the first-line treatment of metastatic colorectal cancer. All the participants will receive the treatment of Apatinib and XELOX combination regimen.
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib and XELOX combined treatment group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib combined treatment group
- description
- Apatinib Mesylate Tablets 500 mg P.O.d1-21 and XELOX (oxaliplatin 130mg/㎡ i.v. d1, capecitabine 1000mg P.O. d1-d14) Every 3-week time is a cycle until PD or intolerance of drug toxicity occurs.
- interventionNames
- Drug: Apatinib and XELOX combined treatment group
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 9 months
- description
- ORR=complete response (CR) + partial response (PR) .And expected ORR is 0.55.
Secondary outcomes (2)
- measure
- Progression-free Survival (PFS)
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable colorectal cancer confirmed by histological means with measurable indication(a minimum size of 10mm by spiral CT scan,which meets the criteria of RECIST 1.1). * Time interval traced back to the latest administration of xelox and folfox combination must be no less than 1 year. * age range: ≥18 and ≤75. * ECOG PS scale 0 or 1;expected survival time ≥12 weeks. * Sufficient blood function:absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥80×109/L and hemoglobin≥9g/dL. * Sufficient hepatic function:total bilirubin ≤1.5 times upper normal limit(ULN), AST ≤2.5 times ULN, ALT ≤2.5 times ULN and AKP ≤5 times ULN. \*AST,ALT relevant criteria alters into AST ≤5 times ULN and ALT ≤5 times ULN if with hepatic metastasis. * sufficient renal function: serum creatinin ≤ULN, creatinine clearance rate ≥60 mL/min * Female patients under age 50 with complete uterus must be tested negative for pregnancy within 28 days before enrollment (except for those who suffered amenorrhea for more than 24 months). If the pregnancy test was carried out more than 7 days before the first administration, then the urine pregnancy test is required for validation. (within the 7-day interval before administration) * Informed consent subscription. (The consent should be approved by independent Ethics Committee, and signed by patients before any substantial trial is initiated.) Exclusion Criteria: * Have got other malignant tumors within last 5 years, excluding basal cell skin cancer and cervical carcinoma in situ that has already been cured. * With evidence of CNS metastasis, even if the treatment had been carried out before, patients with doubts of CNS metastasis should be conducted MRI or enhanced CT scan on within 28 days before enrollment for ruling out. * AST ≤2.5 times ULN and/or ALT ≤2.5 times ULN * Had been treated with chemotherapy for last 12 months * Had been treated with radiotherapy (except for palliative radiotherapy with evaluable focus outside radiotherapy field on purpose of alleviating pains) * With any uncontrolled systemic disease, including active infection, hypertension without treatment, diabetes mellitus, angina pectoris, congestive heart failure, myocardial infarction, severe arrhythmia requires treatment and hepatic/renal/metabolic diseases * Taking experimental treatment from another clinical trial study. * Being allergic to any relevant chemotherapy drug. * With evidence-proved other diseases, neural or metabolic disorders, physical or lab examination abnormalities, which might be contraindication of study drugs or leading to treating-related lethal complications.
References
Publications (12)
- RESULTLi J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16. PMID 26884585
- RESULTTabernero J, Van Cutsem E, Lakomy R, Prausova J, Ruff P, van Hazel GA, Moiseyenko VM, Ferry DR, McKendrick JJ, Soussan-Lazard K, Chevalier S, Allegra CJ. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer. 2014 Jan;50(2):320-31. doi: 10.1016/j.ejca.2013.09.013. Epub 2013 Oct 16. PMID 24140268
- RESULTKara O, Duman BB, Kara B, Erdogan S, Parsak CK, Sakman G. Analysis of PTEN, VEGF, HER2 and P53 status in determining colorectal cancer benefit from bevacizumab therapy. Asian Pac J Cancer Prev. 2012;13(12):6397-401. doi: 10.7314/apjcp.2012.13.12.6397. PMID 23464465
- RESULTCustodio A, Barriuso J, de Castro J, Martinez-Marin V, Moreno V, Rodriguez-Salas N, Feliu J. Molecular markers to predict outcome to antiangiogenic therapies in colorectal cancer: current evidence and future perspectives. Cancer Treat Rev. 2013 Dec;39(8):908-24. doi: 10.1016/j.ctrv.2013.02.004. Epub 2013 Mar 16. PMID 23510598
- RESULTBruera G, Cannita K, Giordano AV, Vicentini R, Ficorella C, Ricevuto E. Effectiveness and safety of intensive triplet chemotherapy plus bevacizumab, FIr-B/FOx, in young-elderly metastatic colorectal cancer patients. Biomed Res Int. 2013;2013:143273. doi: 10.1155/2013/143273. Epub 2013 Nov 6. PMID 24307987
- RESULTSclafani F, Cunningham D. Bevacizumab in elderly patients with metastatic colorectal cancer. J Geriatr Oncol. 2014 Jan;5(1):78-88. doi: 10.1016/j.jgo.2013.08.006. Epub 2013 Sep 20.