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

Primary Purpose

Colorectal Neoplasms

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Two Anti-angiogenesis Drugs(Endostar and Thalidomide)
Pure chemotherapy(Xelox)
Sponsored by
The First People's Hospital of Hefei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Anti-angiogenesis Drugs, Advanced Colorectal Cancer, Endostar, Thalidomide, Vascular Endothelial Growth Factor A

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Cancer HospitalRecruiting
  • Anhui Jimin Cancer HospitalRecruiting
  • The First People's Hospital of HefeiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Two Anti-angiogenesis Drugs(Endostar and Thalidomide)

Pure chemotherapy(Xelox)

Arm Description

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

chemotherapy alone for the patients of Advanced Colorectal Cancer

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 20, 2016
Last Updated
April 21, 2016
Sponsor
The First People's Hospital of Hefei
Collaborators
Anhui Provincial Cancer Hospital, Anhui Jimin Cancer Hospital, Simcere Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02748772
Brief Title
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First People's Hospital of Hefei
Collaborators
Anhui Provincial Cancer Hospital, Anhui Jimin Cancer Hospital, Simcere Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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. 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); Evaluated the security and tolerance by treating with Endostar and Thalidomide (the occurrence of adverse reaction, the degree, the regularity and control measures, etc.); 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Anti-angiogenesis Drugs, Advanced Colorectal Cancer, Endostar, Thalidomide, Vascular Endothelial Growth Factor A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Two Anti-angiogenesis Drugs(Endostar and Thalidomide)
Arm Type
Active Comparator
Arm Description
Two Anti-angiogenesis Drugs(Endostar and Thalidomide) Combined With Chemotherapy for the patients of Advanced Colorectal Cancer
Arm Title
Pure chemotherapy(Xelox)
Arm Type
Placebo Comparator
Arm Description
chemotherapy alone for the patients of Advanced Colorectal Cancer
Intervention Type
Drug
Intervention Name(s)
Two Anti-angiogenesis Drugs(Endostar and Thalidomide)
Other Intervention Name(s)
rh-Endostatin;Distaval
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pure chemotherapy(Xelox)
Other Intervention Name(s)
CapeOX
Intervention Description
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.
Primary Outcome Measure Information:
Title
PFS
Description
Adoption of internationally accepted evaluation oncology research progression-free survival (PFS) as a main observation indexes.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
RR
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FU DAI, Master
Phone
+8613705609377
Email
hfsyydf@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
YANGYI BAO, Bachelor
Phone
+8618655168357
Email
Dr_yangyibao@hotmail.com
Facility Information:
Facility Name
Anhui Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHANGLU HU, Bachelor
Phone
+8613955116061
Email
huchanglu@csco.org.cn
Facility Name
Anhui Jimin Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AIGUO LIU, Doctor
Phone
+8613805512862
Email
lag5912@163.com
Facility Name
The First People's Hospital of Hefei
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FU DAI, Master
Phone
+8613705609377
Email
hfsyydf@sina.com
First Name & Middle Initial & Last Name & Degree
YANGYI BAO, Bachelor
Phone
+8618655168357
Email
Dr_yangyibao@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical

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