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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-OPC-15005865 |
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Date of registration:
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2015-09-01 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective, Multicenter, Registry study of Oxaliplatin (Eloxatin)/Fluorouracil based regimen for Chinese Local Advanced or Metastatic Hepatocellular Carcinoma patients ineligible for curative resection and local treatment
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Scientific title:
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Prospective, Multicenter, Registry study of Oxaliplatin (Eloxatin)/Fluorouracil based regimen for Chinese Local Advanced or Metastatic Hepatocellular Carcinoma patients ineligible for curative resection and local treatment |
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Date of first enrolment:
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2014-09-01 |
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Target sample size:
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Case series:500; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=10309 |
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Study type:
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Observational study |
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Study design:
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Case series
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Wang Qianqian
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Address:
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2F, Haihang Building, 108 Jianguo Road, Chaoyang District, Beijing
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Telephone:
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+86 010-65634982 |
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Email:
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Qianqian.Wang@sanofi.com |
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Affiliation:
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SANOFI (CHINA) INVESTMENT CO., LTD. |
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Name:
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Liu Qing
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Address:
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17F Tower III, Kerry Centre 1228 Yan'an Road, Jing An District, Shanghai
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Telephone:
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+86 021-22266623 |
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Email:
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Qing1.Liu@sanofi.com |
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Affiliation:
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SANOFI (CHINA) INVESTMENT CO., LTD. SHANGHAI BRANCH |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male or female;
2. From 18 to 70 years old;
3. Histologically, cytologically diagnosed HCC which are ineligible for curative resection and local treatment;
4. Or clinically diagnosed HCC which are ineligible for curative resection or local treatment;
5. Or patients with histologically, cytological or clinically diagnosed HCC who are not willing to accept resection and local treatment;
6. Physicians intention to treat with Eloxatin/Fluorouracil based systemic chemotherapy;
7. Signed informed consent form (ICF) prior to study entry.
Exclusion criteria: 1. Patients who are receiving any other study treatments or experimental medical treatment within 30 days prior to study entry;
2. Documented allergy to platinum compound;
3. Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatocellular Carcinoma
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Intervention(s)
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Case series:NA;
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Primary Outcome(s)
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The frequency of drug-related high-grade (Grade 3 and 4) liver toxicity;
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Secondary Outcome(s)
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The frequency and severity of all other adverse events (AE);Overall Survival (OS);Progression Free Survival (PFS);Objective Response Rate (ORR);Disease Control Rate (DCR);Number of cycles;Dose-intensity;Relative dose-intensity;
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Source(s) of Monetary Support
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Sanofi (Hangzhou) Pharmaceuticals Co., Ltd
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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