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

NCT02748772 | Unknown Phase 3 DMC

• 1 other identifier: FirstPeoplesHHeFei
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 3

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).

Conditions

Colorectal Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• PFS

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

  2 Years

Secondary Outcomes (1)

• RR

  2 Years

Study Arms (2)

Two Anti-angiogenesis Drugs（Endostar and Thalidomide）

ACTIVE COMPARATOR

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）

Pure chemotherapy（Xelox）

PLACEBO COMPARATOR

chemotherapy alone for the patients of Advanced Colorectal Cancer

Drug: Pure chemotherapy（Xelox）

Interventions

Two Anti-angiogenesis Drugs（Endostar and Thalidomide） DRUG

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

Two Anti-angiogenesis Drugs（Endostar and Thalidomide）

Pure chemotherapy（Xelox） DRUG

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

Pure chemotherapy（Xelox）; Two Anti-angiogenesis Drugs（Endostar and Thalidomide）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Hefei: lead
• Anhui Provincial Cancer Hospital: collaborator
• Anhui Jimin Cancer Hospital: collaborator
• Simcere Pharmaceutical Co., Ltd: collaborator

Study Sites (3)

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

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

FU DAI, Master

CONTACT

+8613705609377; hfsyydf@sina.com

YANGYI BAO, Bachelor

CONTACT

+8618655168357; Dr_yangyibao@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

CN (3)