Safety and Efficacy of Anlotinib in Combination With Irinotecan in Patients With Pretreated Advanced Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03545711|
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : August 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colo-rectal Cancer||Drug: Anlotinib Hydrochloride with Irinotecan||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Irinotecan Combined With Anlotinib in Patients With Pretreated Advanced Colorectal Cancer|
|Actual Study Start Date :||May 26, 2018|
|Estimated Primary Completion Date :||November 24, 2019|
|Estimated Study Completion Date :||November 24, 2020|
|Experimental: Anlotinib plus Irinotecan||
Drug: Anlotinib Hydrochloride with Irinotecan
Dose escalation of anlotinib starts from 8mg qd d1-14/q21d in combination with fixed dose of irinotecan at 180mg/m2 d1/q14d.
- MTD [ Time Frame: 6 months ]the maximum tolerated dose (MTD) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.
- ORR [ Time Frame: 18 months ]the overall response rate (ORR) of Anlotinib when administered in combination with fixed dose of irinotecan in advanced colorectal cancer patients.
- DCR [ Time Frame: 18 months ]the disease control rate (DCR) of the combination of Anlotinib with Irinotecan in pretreated advanced colorectal cancer patients.
- PFS [ Time Frame: 18 months ]the progression free survival (PFS) of the combination of Anlotinib with Irinotecan in pretreated advanced colorectal cancer patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545711
|Contact: Jing Huang, MDemail@example.com|
|Contact: Yan Song, M.D|
|Beijing, China, 100021|
|Contact: Jing Huang, MD|
|Principal Investigator:||Jing Huang, MD||Cancer Hospital,CAMS|