CClinicalTrials.gg
Sign In
Status unknownNCT02748772Updated Apr 22, 2016

Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical

A Phase 3 interventional study of Two Anti-angiogenesis Drugs（Endostar and Thalidomide） and Pure chemotherapy（Xelox） in Colorectal Neoplasms, sponsored by The First People's Hospital of Hefei. Status unknown at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-22.

Sponsored by The First People's Hospital of Hefei · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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).

Read the detailed description

Endostar have anti-tumor activity by against vascular endothelial growth factor.

Thalidomide is a therapeutic for insomnia and vomiting. It is also used for tumor treatment as an Anti-angiogenesis drug and immune regulator in recently years.

  1. Evaluated the therapeutic effects and survival benefits of ACRC treatment by using the Endostar and Thalidomide combined with XELOX regimens. (including the RR, DCR, PFS, and QOL);
  2. Evaluated the security and tolerance by treating with Endostar and Thalidomide (the occurrence of adverse reaction, the degree, the regularity and control measures, etc.);
  3. Detected the histological markers (VEGF/VEGFR, PDGF/PDGFR, BFGF/FGFR, cox-2, Her-2, K-Ras and p53) before the patients into the group. Make a retrospective analysis of individual molecules indicators to guide significant therapy of ACRC.
02

Conditions studied

  • Colorectal Neoplasms

Keywords

  • Anti-angiogenesis Drugs
  • Advanced Colorectal Cancer
  • Endostar
  • Thalidomide
  • Vascular Endothelial Growth Factor A
03

In context

Colorectal Neoplasms

5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 148 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

This is the only study on the registry with The First People's Hospital of Hefei as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
148 participants (estimated)

Study arms

  • Active comparator
    Two Anti-angiogenesis Drugs（Endostar and Thalidomide）

    Two Anti-angiogenesis Drugs（Endostar and Thalidomide） Combined With Chemotherapy for the patients of Advanced Colorectal Cancer

    Drug: Two Anti-angiogenesis Drugs（Endostar and Thalidomide） · Drug: Pure chemotherapy（Xelox）

  • Placebo comparator
    Pure chemotherapy（Xelox）

    chemotherapy alone for the patients of Advanced Colorectal Cancer

    Drug: Pure chemotherapy（Xelox）

Interventions

  • DrugTwo Anti-angiogenesis Drugs（Endostar and Thalidomide）

    Endostar:30 mg/d, CIV (continous intravenous pumping) on day 7 of each 21 day cycle，5 days before the chemotherapy is the first day; Thalidomide:100-200mg/d,PO (peros) on day 14 of each 21 day cycle Number of Cycles: 6 cycle or progression or unacceptable toxicity develops.

    Also known as: rh-Endostatin；Distaval

  • DrugPure chemotherapy（Xelox）

    CapeOX (also called XELOX) is a chemotherapy regimen consisting of capecitabine (trade name Xeloda) combined with oxaliplatin. Oxaliplatin 130mg/m2 IV over 2 hours,day1 Capecitabine 850-1000mg/m2 twice daily PO for 14 days Repeat every 3 weeks Number of Cycles: 6 cycle or progression or unacceptable toxicity develops.

    Also known as: CapeOX

06

What researchers measure

Primary outcomes

  1. PFS

    Adoption of internationally accepted evaluation oncology research progression-free survival (PFS) as a main observation indexes.

    Time frame: 2 Years

Secondary outcomes

  1. RR

    Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment. divided into complete remission (CR), partial response (PR), stable (SD) and development (PD). The total effective rate (RR) refers to the percentage of CR + PR.

    Time frame: 2 Years

07

Study locations

3 of 3 sites recruiting
  • Anhui Cancer Hospital
    Hefei, Anhui 230000, China
    Recruiting
  • Anhui Jimin Cancer Hospital
    Hefei, Anhui 230000, China
    Recruiting
  • The First People's Hospital of Hefei
    Hefei, Anhui 230000, China
    Recruiting
08

References and documents

Publications

  • Gamelin 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. Erratum In: J Clin Oncol. 2013 Oct 1;31(28):3612. PubMed 18445839 ↗
  • Haller 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. PubMed 21383294 ↗
  • Folkman J. Angiogenesis: an organizing principle for drug discovery? Nat Rev Drug Discov. 2007 Apr;6(4):273-86. doi: 10.1038/nrd2115. PubMed 17396134 ↗
  • O'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. PubMed 9008168 ↗
  • Wang 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. PubMed 21108883 ↗
  • Ling 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. PubMed 17644065 ↗
  • Kim YM, Hwang S, Kim YM, Pyun BJ, Kim TY, Lee ST, Gho YS, Kwon YG. Endostatin blocks vascular endothelial growth factor-mediated signaling via direct interaction with KDR/Flk-1. J Biol Chem. 2002 Aug 2;277(31):27872-9. doi: 10.1074/jbc.M202771200. Epub 2002 May 23. PubMed 12029087 ↗
  • Li XQ, Shang BY, Wang DC, Zhang SH, Wu SY, Zhen YS. Endostar, a modified recombinant human endostatin, exhibits synergistic effects with dexamethasone on angiogenesis and hepatoma growth. Cancer Lett. 2011 Feb 28;301(2):212-20. doi: 10.1016/j.canlet.2010.12.004. Epub 2011 Jan 7. PubMed 21216091 ↗
  • Dahut WL, Gulley JL, Arlen PM, Liu Y, Fedenko KM, Steinberg SM, Wright JJ, Parnes H, Chen CC, Jones E, Parker CE, Linehan WM, Figg WD. Randomized phase II trial of docetaxel plus thalidomide in androgen-independent prostate cancer. J Clin Oncol. 2004 Jul 1;22(13):2532-9. doi: 10.1200/JCO.2004.05.074. PubMed 15226321 ↗
  • McMeekin DS, Sill MW, Darcy KM, Stearns-Kurosawa DJ, Webster K, Waggoner S, Benbrook D. A phase II trial of thalidomide in patients with refractory leiomyosarcoma of the uterus and correlation with biomarkers of angiogenesis: a gynecologic oncology group study. Gynecol Oncol. 2007 Sep;106(3):596-603. doi: 10.1016/j.ygyno.2007.05.013. Epub 2007 Jun 27. PubMed 17597196 ↗
  • Dredge K, Marriott JB, Macdonald CD, Man HW, Chen R, Muller GW, Stirling D, Dalgleish AG. Novel thalidomide analogues display anti-angiogenic activity independently of immunomodulatory effects. Br J Cancer. 2002 Nov 4;87(10):1166-72. doi: 10.1038/sj.bjc.6600607. PubMed 12402158 ↗
  • Gupta D, Treon SP, Shima Y, Hideshima T, Podar K, Tai YT, Lin B, Lentzsch S, Davies FE, Chauhan D, Schlossman RL, Richardson P, Ralph P, Wu L, Payvandi F, Muller G, Stirling DI, Anderson KC. Adherence of multiple myeloma cells to bone marrow stromal cells upregulates vascular endothelial growth factor secretion: therapeutic applications. Leukemia. 2001 Dec;15(12):1950-61. doi: 10.1038/sj.leu.2402295. PubMed 11753617 ↗
  • Wang Z, Dabrosin C, Yin X, Fuster MM, Arreola A, Rathmell WK, Generali D, Nagaraju GP, El-Rayes B, Ribatti D, Chen YC, Honoki K, Fujii H, Georgakilas AG, Nowsheen S, Amedei A, Niccolai E, Amin A, Ashraf SS, Helferich B, Yang X, Guha G, Bhakta D, Ciriolo MR, Aquilano K, Chen S, Halicka D, Mohammed SI, Azmi AS, Bilsland A, Keith WN, Jensen LD. Broad targeting of angiogenesis for cancer prevention and therapy. Semin Cancer Biol. 2015 Dec;35 Suppl(Suppl):S224-S243. doi: 10.1016/j.semcancer.2015.01.001. Epub 2015 Jan 16. PubMed 25600295 ↗
  • Narita K, Fujii T, Ishiwata T, Yamamoto T, Kawamoto Y, Kawahara K, Nakazawa N, Naito Z. Keratinocyte growth factor induces vascular endothelial growth factor-A expression in colorectal cancer cells. Int J Oncol. 2009 Feb;34(2):355-60. PubMed 19148469 ↗
  • Heldin CH, Westermark B. Mechanism of action and in vivo role of platelet-derived growth factor. Physiol Rev. 1999 Oct;79(4):1283-316. doi: 10.1152/physrev.1999.79.4.1283. PubMed 10508235 ↗
  • Appelmann I, Liersch R, Kessler T, Mesters RM, Berdel WE. Angiogenesis inhibition in cancer therapy: platelet-derived growth factor (PDGF) and vascular endothelial growth factor (VEGF) and their receptors: biological functions and role in malignancy. Recent Results Cancer Res. 2010;180:51-81. doi: 10.1007/978-3-540-78281-0_5. PubMed 20033378 ↗
  • Casanovas O, Hicklin DJ, Bergers G, Hanahan D. Drug resistance by evasion of antiangiogenic targeting of VEGF signaling in late-stage pancreatic islet tumors. Cancer Cell. 2005 Oct;8(4):299-309. doi: 10.1016/j.ccr.2005.09.005. PubMed 16226705 ↗
  • Chao C, Carmical JR, Ives KL, Wood TG, Aronson JF, Gomez GA, Djukom CD, Hellmich MR. CD133+ colon cancer cells are more interactive with the tumor microenvironment than CD133- cells. Lab Invest. 2012 Mar;92(3):420-36. doi: 10.1038/labinvest.2011.185. Epub 2011 Dec 12. PubMed 22157717 ↗
  • Saukkonen K, Nieminen O, van Rees B, Vilkki S, Harkonen M, Juhola M, Mecklin JP, Sipponen P, Ristimaki A. Expression of cyclooxygenase-2 in dysplasia of the stomach and in intestinal-type gastric adenocarcinoma. Clin Cancer Res. 2001 Jul;7(7):1923-31. PubMed 11448905 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02748772
Lead sponsor
The First People's Hospital of Hefei
Collaborators
Anhui Provincial Cancer Hospital, Anhui Jimin Cancer Hospital, Simcere Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Apr 22, 2016
Start date
Jan 2016
Primary completion
Dec 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Apr 22, 2016

Study contacts

FU DAI, Master
Contact
hfsyydf@sina.com
+8613705609377
YANGYI BAO, Bachelor
Contact
Dr_yangyibao@hotmail.com
+8618655168357

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colorectal Neoplasms→

Start the discussion