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Trial record 10 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

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

This study is currently recruiting participants.
Verified April 2016 by The First People's Hospital of Hefei
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748772
First Posted: April 22, 2016
Last Update Posted: April 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Anhui Cancer Hospital
Anhui Jimin Cancer Hospital
Simcere Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
The First People's Hospital of Hefei
  Purpose
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).

Condition Intervention Phase
Colorectal Neoplasms Drug: Two Anti-angiogenesis Drugs(Endostar and Thalidomide) Drug: Pure chemotherapy(Xelox) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The First People's Hospital of Hefei:

Primary Outcome Measures:
  • PFS [ Time Frame: 2 Years ]
    Adoption of internationally accepted evaluation oncology research progression-free survival (PFS) as a main observation indexes.


Secondary Outcome Measures:
  • RR [ Time Frame: 2 Years ]
    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.


Estimated Enrollment: 148
Study Start Date: January 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.
Other Name: rh-Endostatin;Distaval
Drug: Pure 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.

Other Name: CapeOX
Placebo Comparator: Pure chemotherapy(Xelox)
chemotherapy alone for the patients of Advanced Colorectal Cancer
Drug: Pure 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.

Other Name: CapeOX

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748772


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

Locations
China, Anhui
Anhui Cancer Hospital Recruiting
Hefei, Anhui, China, 230000
Contact: CHANGLU HU, Bachelor    +8613955116061    huchanglu@csco.org.cn   
Anhui Jimin Cancer Hospital Recruiting
Hefei, Anhui, China, 230000
Contact: AIGUO LIU, Doctor    +8613805512862    lag5912@163.com   
The First People's Hospital of Hefei Recruiting
Hefei, Anhui, China, 230000
Contact: FU DAI, Master    +8613705609377    hfsyydf@sina.com   
Contact: YANGYI BAO, Bachelor    +8618655168357    Dr_yangyibao@hotmail.com   
Sponsors and Collaborators
The First People's Hospital of Hefei
Anhui Cancer Hospital
Anhui Jimin Cancer Hospital
Simcere Pharmaceutical Co., Ltd
  More Information

Publications:

Responsible Party: The First People's Hospital of Hefei
ClinicalTrials.gov Identifier: NCT02748772     History of Changes
Other Study ID Numbers: FirstPeoplesHHeFei
First Submitted: April 20, 2016
First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by The First People's Hospital of Hefei:
Anti-angiogenesis Drugs
Advanced Colorectal Cancer
Endostar
Thalidomide
Vascular Endothelial Growth Factor A

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents