Clinical trial · Interventional
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical
NCT02748772CI-TRIAL-00021892unknownPhase 3ClinicalTrials.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 purpose of this study is to determine whether Endostar pumping into vein with Thalidomide are more effective in the treatment of Advanced Colorectal Cancer (ACRC).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pure chemotherapy(Xelox) | Drug | — | UNRESOLVED |
| Two Anti-angiogenesis Drugs(Endostar and Thalidomide) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Two Anti-angiogenesis Drugs(Endostar and Thalidomide)
- description
- Two Anti-angiogenesis Drugs(Endostar and Thalidomide) Combined With Chemotherapy for the patients of Advanced Colorectal Cancer
- interventionNames
- Drug: Two Anti-angiogenesis Drugs(Endostar and Thalidomide)
- Drug: Pure chemotherapy(Xelox)
- type
- PLACEBO_COMPARATOR
- label
- Pure chemotherapy(Xelox)
- description
- chemotherapy alone for the patients of Advanced Colorectal Cancer
- interventionNames
- Drug: Pure chemotherapy(Xelox)
Primary outcomes (1)
- measure
- PFS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patients with stage IV colorectal cancer can't receive operative treatment diagnosed by Histopathological or cytological examination or can receive operation after conversion therapy. 2. The niave patients relapse and metastasize after more than 6 months' chemotherapeutic diapause after operation or adjuvant chemotherapy or refuse to another operate or need operate only after conversion therapy 3. Have at least one measurable nidus, Ordinary CT or MRI scan nidus 20 mm or higher, Spiral CT and PET - CT scan nidus 10 mm or higher. 4. The first 3 weeks before entering the group have stopped chemotherapy or radiotherapy and recovered from previous treatment of toxic effects. The patients who have received the treatment of delayed toxicity drugs (such as mitomycin or nitrourea) should stop treatment of 6 weeks; 5. ECOG score of 0 to 2 points. 6. Expected survival period for 3 months or more. 7. Aged 18 to 75 years of age, and gender not limited. 8. The electrocardiogram is normal and the body doesn't have unhealed wounds. 9. Peripheral blood cell count, WBC 4.0 x 109 / L or higher, PLT 80 x 109 / L or higher, Hb 90 g/L or higher. 10. Renal function, Cr 2.0 x UNL (upper limit of normal) or less. 11. Liver function, AST, ALT were 2.5 times the normal limit or less (if identified as liver metastasis, five times the normal limit or less). 12. Previous have no severe allergic reactions on biological agents, especially e. coli genetically engineered products. 13. Voluntary to participate in groups, good compliance, willing to cooperate with test observation and sign a written informed consent. Exclusion Criteria: 1. Pregnant, lactating women,or female patient who have fertility ability but have not taken contraceptive measures; 2. Patients who exist serious acute infection and have not been controlled;or patients who exist purulent infection,chronic infection and delayed wound healing; 3. Patients with serious heart disease, including:congestive heart failure ,uncontrollable high-risk arrhythmias,unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension; 4. Patients whose target lesions had previously received radiation therapy or other topical treatment(radio frequency, ultrasonic, freezing); 5. Patients who suffered from uncontrollable neurological and psychiatric diseases or mental disorders, have poor compliance as well as can not cope with others and failed to narrative therapy respond;patients whose primary brain or central nervous system metastases disease had not been controlled and those with Cranial hypertension or neuropsychiatric symptoms; 6. Patients who had meanwhile participated in other clinical trials; 7. Other circumstances which researchers considered that patients should not participate in this test.
References
Publications (19)
- BACKGROUNDGamelin E, Delva R, Jacob J, Merrouche Y, Raoul JL, Pezet D, Dorval E, Piot G, Morel A, Boisdron-Celle M. Individual fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: results of a multicenter randomized trial of patients with metastatic colorectal cancer. J Clin Oncol. 2008 May 1;26(13):2099-105. doi: 10.1200/JCO.2007.13.3934. PMID 18445839
- BACKGROUNDHaller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011 Apr 10;29(11):1465-71. doi: 10.1200/JCO.2010.33.6297. Epub 2011 Mar 7. PMID 21383294
- BACKGROUNDFolkman J. Angiogenesis: an organizing principle for drug discovery? Nat Rev Drug Discov. 2007 Apr;6(4):273-86. doi: 10.1038/nrd2115. PMID 17396134
- BACKGROUNDO'Reilly MS, Boehm T, Shing Y, Fukai N, Vasios G, Lane WS, Flynn E, Birkhead JR, Olsen BR, Folkman J. Endostatin: an endogenous inhibitor of angiogenesis and tumor growth. Cell. 1997 Jan 24;88(2):277-85. doi: 10.1016/s0092-8674(00)81848-6. PMID 9008168
- BACKGROUNDWang J, Sun Y, Liu Y, Yu Q, Zhang Y, Li K, Zhu Y, Zhou Q, Hou M, Guan Z, Li W, Zhuang W, Wang D, Liang H, Qin F, Lu H, Liu X, Sun H, Zhang Y, Wang J, Luo S, Yang R, Tu Y, Wang X, Song S, Zhou J, You L, Wang J, Yao C. [Results of randomized, multicenter, double-blind phase III trial of rh-endostatin (YH-16) in treatment of advanced non-small cell lung cancer patients]. Zhongguo Fei Ai Za Zhi. 2005 Aug 20;8(4):283-90. doi: 10.3779/j.issn.1009-3419.2005.04.07. Chinese. PMID 21108883
- BACKGROUNDLing Y, Yang Y, Lu N, You QD, Wang S, Gao Y, Chen Y, Guo QL. Endostar, a novel recombinant human endostatin, exerts antiangiogenic effect via blocking VEGF-induced tyrosine phosphorylation of KDR/Flk-1 of endothelial cells. Biochem Biophys Res Commun. 2007 Sep 14;361(1):79-84. doi: 10.1016/j.bbrc.2007.06.155. Epub 2007 Jul 10.