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Colorectal NeoplasmsPhase 3NCT02748772

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

A Phase 3 study testing Two Anti-angiogenesis Drugs（Endostar and Thalidomide） and Pure chemotherapy（Xelox） in people with Colorectal Neoplasms, run by The First People's Hospital of Hefei at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Neoplasms
What is being tested?
Two Anti-angiogenesis Drugs（Endostar and Thalidomide） and Pure chemotherapy（Xelox）
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
148 participants
Where
3 sitesChina
Study dates
Jan 2016to Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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
  • 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.
  • 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;
  • ECOG score of 0 to 2 points.
  • Expected survival period for 3 months or more.
Show all 13Show fewer
  • Aged 18 to 75 years of age, and gender not limited.
  • The electrocardiogram is normal and the body doesn't have unhealed wounds.
  • 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.
  • Renal function, Cr 2.0 x UNL (upper limit of normal) or less.
  • 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).
  • Previous have no severe allergic reactions on biological agents, especially e. coli genetically engineered products.
  • Voluntary to participate in groups, good compliance, willing to cooperate with test observation and sign a written informed consent.

Who cannot join

  • Pregnant, lactating women,or female patient who have fertility ability but have not taken contraceptive measures;
  • Patients who exist serious acute infection and have not been controlled；or patients who exist purulent infection,chronic infection and delayed wound healing;
  • Patients with serious heart disease, including:congestive heart failure ,uncontrollable high-risk arrhythmias,unstable angina, myocardial infarction, severe heart valve disease and resistant hypertension;
  • Patients whose target lesions had previously received radiation therapy or other topical treatment(radio frequency, ultrasonic, freezing);
  • 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;
  • Patients who had meanwhile participated in other clinical trials;
  • Other circumstances which researchers considered that patients should not participate in this test.

Trial locations and contacts

3 sites in 1 country.

FU DAI, Master contact

+8613705609377

hfsyydf@sina.com

YANGYI BAO, Bachelor contact

+8618655168357

Dr_yangyibao@hotmail.com

China3 sites, 3 recruiting

  • Anhui Cancer Hospital

    Hefei, Anhui, 230000

    CHANGLU HU, Bachelor, +8613955116061, huchanglu@csco.org.cn

    Recruiting

  • Anhui Jimin Cancer Hospital

    Hefei, Anhui, 230000

    AIGUO LIU, Doctor, +8613805512862, lag5912@163.com

    Recruiting

  • The First People's Hospital of Hefei

    Hefei, Anhui, 230000

    FU DAI, Master, +8613705609377, hfsyydf@sina.com

    YANGYI BAO, Bachelor, +8618655168357, Dr_yangyibao@hotmail.com

    Recruiting

Other trials in China

About this study

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.
Being tested
Two Anti-angiogenesis Drugs（Endostar and Thalidomide）, Pure chemotherapy（Xelox）
Keywords
Anti-angiogenesis Drugs, Advanced Colorectal Cancer, Endostar, Thalidomide, Vascular Endothelial Growth Factor A
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Two Anti-angiogenesis Drugs（Endostar and Thalidomide）Drug

    Also called rh-Endostatin；Distaval

    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.

  • Pure chemotherapy（Xelox）Drug

    Also called CapeOX

    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.

Study groups in NCT02748772
Study groupRoleWhat they receive
Two Anti-angiogenesis Drugs（Endostar and Thalidomide）Active comparatorTwo Anti-angiogenesis Drugs（Endostar and Thalidomide） Combined With Chemotherapy for the patients of Advanced Colorectal Cancer
Receives: Drug: Two Anti-angiogenesis Drugs（Endostar and Thalidomide）; Drug: Pure chemotherapy（Xelox）
Pure chemotherapy（Xelox）Placebo comparatorchemotherapy alone for the patients of Advanced Colorectal Cancer
Receives: Drug: Pure chemotherapy（Xelox）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

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

    Measured: 2 Years

Secondary outcomes (1)

  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.

    Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
148 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02748772
Sponsor's protocol ID
FirstPeoplesHHeFei
Status last verified
Apr 2016
First submitted
20 Apr 2016
Last updated
22 Apr 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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.

    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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Two Anti-angiogenesis Drugs（Endostar and Thalidomide） and Pure chemotherapy（Xelox） in people with Colorectal Neoplasms, run by The First People's Hospital of Hefei at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact FU DAI, Master (+8613705609377, hfsyydf@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02748772, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.

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