Study to Evaluate the Safety, Preliminary Efficacy and Pharmacokinetics of 3810
- Registration Number
- NCT03260179
- Lead Sponsor
- Haihe Biopharma Co., Ltd.
- Brief Summary
This project intends to make a study of personalized medicine evaluation system establishment for liver cancer, gastric cancer and nasopharynx cancer to provide strong support for the development of Precision Medicine and personalized medicine for the patients of high-incidence-rates cancer in China.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description gastric carcinoma AL3810 20 gastric carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810 hepatocellular carcinoma AL3810 20 hepatocellular carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810 Nasopharyngeal carcinoma AL3810 20 Nasopharyngeal carcinoma patients were randomly divided into two groups: 4W on or 3w on/1w off, oral AL3810
- Primary Outcome Measures
Name Time Method AE through study completion, an average of 1 year the number of patients with grade 3 and 4 AE according to CTC AE 4.03
- Secondary Outcome Measures
Name Time Method ORR through study completion, an average of 1 year The proportion of patients who have observed overall remission (CR) or partial remission (PR) as the overall optimal remission based on the RECIST 1.1.
AUC up to 3 cycles(28 days/cycle) Area under the plasma concentration versus time curve
Cmax up to 3 cycles(28 days/cycle) Peak Plasma Concentration
DoR through study completion, an average of 1 year All patients with the best overall response to CR or PR were required to calculate the duration of the response. This time is the duration (progression or death, whichever occurs first) from the first decision to CR or PR to tumor progression or death (death for any cause)
DCR through study completion, an average of 1 year DCR refers to the percentage of patients who have achieved confirmation during the treatment of CR, confirmed PR and / or SD
PFS through study completion, an average of 1 year To the date of randomization to the date of the onset of the disease or the date of death (regardless of the cause of the death) (whichever is the earlier).
Trial Locations
- Locations (6)
The 307th Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Sun Yat-sen University Cancer Center
🇨🇳Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
The 81st Hospital of People's Liberation Army
🇨🇳Nanjing, Jiangsu, China