Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
| Beijing gene plus technology co., LTD | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Limited agents have been approved after standard first and second line treatment. Regorafenib and Trifluridine/Tipiracil (TAS-102) are still not approved in China.Apatinib has shown significant efficacy in refractory advanced gastric cancer regarding PFS and OS with controllable toxicity.This study is aimed to explore the efficacy,safety as well as predictive biomarker in advanced colorectal cancer failed to standard therapy in Chinese population.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug,apatinib | Experimental | apatinib 500mg/qd, 28d/cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib | Drug | apatinib 500mg/qd, 28d/cycle |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival(PFS) | PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. | From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from date of assignment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact. | From assignment of the first subject until 40 death events observed, up to 2 years. |
| Disease control rate (DCR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yanhong Gu, Dr. | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the second hospital of Changzhou city | Changzhou | Jiangsu | 213000 | China | ||
| Nanjing 81 Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26884585 | Background | Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16. | |
| 23918952 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C553458 | apatinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD) |
| From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019 |
| Objective response rate(ORR) | The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR) | From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019 |
| Quality of life | The general well-being of participants, outlining negative and positive features of life. | From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019 |
| relationship between the tumor molecular burden & gene mutation and the drug efficacy. | The tumor molecular clones and gene mutations of 1021 tumor related genes will be detected by next-generation sequencing,which will be matched with the CT scanning . | From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | adverse events will be assessed according to CTCAE v4.0, including hematological and non-hematological adverse events. Non-hematological adverse events will be collected by patients reported outcomes questionaire. The adverse events of interest include hypertension,hand-foot syndrome,proteinuria,hoarseness,rash,etc.The dose reduction and drug discontinuance due to adverse events will also be recorded. | From assignment of the first subject to 3 months later after the last participant is recruited.The last participant will be recruited before Mar 30,2019. |
| Nanjing |
| Jiangsu |
| 210000 |
| China |
| the first affiliated hospital with Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| Jiangnan University affiliated hospital | Wuxi | Jiangsu | 214000 | China |
| Background |
| Li J, Qin S, Xu J, Guo W, Xiong J, Bai Y, Sun G, Yang Y, Wang L, Xu N, Cheng Y, Wang Z, Zheng L, Tao M, Zhu X, Ji D, Liu X, Yu H. Apatinib for chemotherapy-refractory advanced metastatic gastric cancer: results from a randomized, placebo-controlled, parallel-arm, phase II trial. J Clin Oncol. 2013 Sep 10;31(26):3219-25. doi: 10.1200/JCO.2013.48.8585. Epub 2013 Aug 5. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |