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Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. |
|
| Placebo group | Placebo Comparator | Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | A multi-target receptor tyrosine kinase inhibitor. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) evaluated by IRC | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) evaluated by investigator | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. | up to 24 months |
| Overall Survival (OS) |
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Inclusion Criteria:
5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi, Doctor | Contact | 010-87788293 | syuankaipumc@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100083 | China |
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| Placebos |
| Drug |
Anlotinib blank analog capsule. |
|
| Paclitaxel | Drug | Paclitaxel 175 mg/m^2 IV on Day 1 of each 21-day cycle. |
|
| Carboplatin | Drug | Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle. |
|
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
| up to 24 months |
| Overall Response Rate (ORR) | Percentage of participants achieving complete response (CR) and partial response (PR). | up to 24 months |
| Disease Control Rate(DCR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 24 months |
| Duration of Overall Response (DOR) | The time when the patient first achieved complete or partial remission to disease progression. | up to 24 months |
| PFS rate at month 6 | The percentage of PFS at month 6. | up to 6 months |
| PFS rate at month 12 | The percentage of PFS at month 12. | up to 12 months |
| OS rate at month 6 | The percentage of OS at month 6. | up to 6 months |
| OS rate at month 12 | The percentage of OS at month 12. | up to 12 months |
| OS rate at month 18 | The percentage of OS at month 18. | up to 18 months |
| Adverse Event (AE) | Safety data | up to 24 months |
| Serious Adverse Event (SAE) | Safety data | up to 24 months |
| Abnormal laboratory test index | Safety data | up to 24 months |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 50011 | China |
|
| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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