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| Name | Class |
|---|---|
| General Hospital of Ningxia Medical University | OTHER |
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Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor celltebiz related kinase -c-Kit kinase. In the phase III study, Patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months.
It is an open, single-arm, multi-center clinical trial conducted in China, and plan to Recruiting 72 patients in the elderly without systemic chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib Hydrochloride | Experimental | Anlotinib Hydrochloride p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib Hydrochloride | Drug | Anlotinib Hydrochloride ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage. Other Name: AL3818 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progress free survival (PFS) | Time Frame: each 42 days up to PD or death(up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival (OS) | From randomization until death (up to 24 months) |
| DCR | Disease Control Rate (DCR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| da zhao, professor | Contact | 0086-13369287188 | Ydfyzhaohon@163.com | |
| rui chen, doctor | Contact | 0086-13919899287 | chrui-001@163.com |
| Name | Affiliation | Role |
|---|---|---|
| xiaoming hou, professor | LanZhou University | Principal Investigator |
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| ORR | Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until 30 day safety follow-up visit |
| EORTC QLQ-C30 | use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life | each 42 days up to intolerance the toxicity or PD (up to 24 months) |