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
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus standard second-line chemotherapy. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or standard second-line chemotherapy, with 1:1 random ratio.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib hydrochloride capsule + AK105 injection | Experimental | Anlotinib hydrochloride capsule 12mg 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) plus AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle. |
|
| Standard Second-line Chemotherapy | Active Comparator | Participants receive 80 mg/m² IV paclitaxel on Days 1, 8 and 15 of each 28-day cycle, or 75mg/m² docetaxel every 3 weeks of each 21-day cycle until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib hydrochloride capsule | Drug | Anlotinib hydrochloride capsule 12mg 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS defined as the time from randomization to death from any cause. Subjects 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 45 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. | up to 45 weeks |
| Overall response rate (ORR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihua Xu | Contact | 020-87343468 | ruihxu@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AK105 injection | Drug | AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle. |
|
| Paclitaxel injection | Drug | Paclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle. |
|
| Docetaxel injection | Drug | Docetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle. |
|
Percentage of subjects achieving complete response (CR) and partial response (PR).
| up to 45 weeks |
| Disease control rate (DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 45 weeks |
| Duration of response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | up to 45 weeks |
| Beijing Shijitan Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | 100038 | China |
|
| The Sixth Medical Center of PLA General Hospital | Beijing | Beijing Municipality | 100048 | China |
|
| Peking University Shougang Hospital | Beijing | Beijing Municipality | 100144 | China |
|
| Beijing Luhe Hospital Capital Medical University | Beijing | Beijing Municipality | 101100 | China |
|
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | 102218 | China |
|
| Fujian Provincial Cancer Hospital | Fuzhou | Fujian | 350011 | China |
|
| Quanzhou First Hospital | Quanzhou | Fujian | 362000 | China |
|
| The Second Affiliated Hospital of Fujian Medical University | Quanzhou | Fujian | 362000 | China |
|
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
|
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | 361004 | China |
|
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
|
| Gansu Wuwei Tumour Hospital | Wuwei | Gansu | 733000 | China |
|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
|
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510610 | China |
|
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524000 | China |
|
| Guangxi Medical University Affiliated Tumor Hospital | Nanning | Guangxi | 530021 | China |
|
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050010 | China |
|
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | 150040 | China |
|
| AnYang Tumor Hospital | Anyang | Henan | 455000 | China |
|
| Xinxiang Central Hospital | Xinxiang | Henan | 453000 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450003 | China |
|
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
|
| Union Hospital,Tongji Medical College,Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei | 430030 | China |
|
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
|
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
|
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | 410011 | China |
|
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
|
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | 210009 | China |
|
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
|
| Nantong Cancer Hospital | Nantong | Jiangsu | 226361 | China |
|
| Wuxi People's Hospital | Wuxi | Jiangsu | 214023 | China |
|
| Hospital of Jiangnan University | Wuxi | Jiangsu | 214062 | China |
|
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
|
| Liaoning Cancar Hospital | Shenyang | Liaoning | 110042 | China |
|
| People's Hospital of Ningxia Hui Autonomous Region | Yinchuan | Ningxia | 750021 | China |
|
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
|
| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | 030013 | China |
|
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | 710004 | China |
|
| First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | 710061 | China |
|
| Tianjin Medical University General Hospital | Tianjing | Tianjing | 300050 | China |
|
| Tianjin Medical University Cancer Institute and Hospital | Tianjing | Tianjing | 300060 | China |
|
| The First People's Hospital of kashi region | Kashgar | XinJiang Uighur Autonomous Region | 844000 | China |
|
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided