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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

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.

Two Anti-angiogenesis Drugs（Endostar and Thalidomide）

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.

Pure chemotherapy（Xelox）

FU DAI, Master

YANGYI BAO, Bachelor

CHANGLU HU, Bachelor

AIGUO LIU, Doctor

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).

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.

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

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

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.

Anhui Provincial Cancer Hospital

Anhui Jimin Cancer Hospital

Simcere Pharmaceutical Co., Ltd

The First People's Hospital of Hefei

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical	NCT02748772	Colorectal Neop...	Two Anti-angiog... Pure chemothera...	18 Years - 75 Years	The First People's Hospital of Hefei
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical	NCT02748772	Colorectal Neop...	Two Anti-angiog... Pure chemothera...	18 Years - 75 Years	The First People's Hospital of Hefei
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical	NCT02748772	Colorectal Neop...	Two Anti-angiog... Pure chemothera...	18 Years - 75 Years	The First People's Hospital of Hefei
Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical	NCT02748772	Colorectal Neop...	Two Anti-angiog... Pure chemothera...	18 Years - 75 Years	The First People's Hospital of Hefei

Spots Global Cancer Trial Database for pure chemotherapy（xelox）