Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

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.

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.

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).

Anlotinib hydrochloride capsule

AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle.

AK105 injection

Paclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle.

Paclitaxel injection

Docetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle.

Docetaxel injection

Ruihua Xu

Kangsheng Gu, Doctor

Jirun Peng, Doctor

Xinhong Zhang, Doctor

Delin Wang

Dong Yan, Doctor

Zhuo Yu, Doctor

Zengqing Guo

Peiling Xin

Tianwen Xu, Doctor

Jiayi Li

Zhijie Ding, Doctor

Xiaoming Hou, Doctor

Linzhi Lu

Ruihua Xu, Doctor

Yanhong Deng, Doctor

Zhong Xie

Jiansi Chen

Da Jiang

Yanqiao Zhang, Doctor

Tao Wu

Guifang Zhang

Yanru Qin, Doctor

Huijuan Wu

Tao Zhang, Doctor

Xianglin Yuan, Doctor

Xinjun Liang, Doctor

Shan Zeng, Doctor

Hongliang Yao, Doctor

Shanzhi Gu

Jianwei Lu, Doctor

Lingjun Zhu, Doctor

Jianhong Wang

Chaoying Liu

Yong Mao, Doctor

Junhe Li, Doctor

Baoli Qin, Doctor

Qingxin Zhuang

Changzheng Li

Qi Li, Doctor

Yusheng Wang, Doctor

Xi Chen, Doctor

Enxiao Li, Doctor

Diansheng Zhong, Doctor

Yi Ba, Doctor

Wei Wang

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.

A Study of Anlotinib Hydrochloride Capsule Combined With AK105 Injection in Subject With Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma

A Randomized, Open-label, Controlled, Multicenter Phase III Study of Hydrochloride Capsule Combined With AK105 Injection Versus Standard Second-line Chemotherapy for Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma

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.

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

Percentage of subjects achieving complete response (CR) and partial response (PR).

Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Amino Acids

Oxaliplatin

Bevacizumab

Fluorouracil

Antibodies

Antibodies, Monoclonal

Capecitabine

Immunoglobulins

Tyrosine Kinase Inhibitors

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tyrosine

Treatment period (6 cycles):

AK105 injection: intravenous drip on Day 1; Anlotinib hydrochloride capsule: oral administration, once daily(QD) ; Oxaliplatin for injection: intravenous infusion on Day 1; Capecitabine tablet:oral administration, twice daily (BID) .

Maintenance period:

AK105 injection: intravenous drip on Day 1; Anlotinib hydrochloride capsule: oral administration, once daily(QD) ; Capecitabine tablet:oral administration, twice daily (BID) . Every 3 weeks is as one cycle.Oxaliplatin is administered for 6 cycles, and AK105 can be administered continuously for 1 year but at most for 2 years. Other cases continue to be administered until the treatment termination event specified in the plan occurs.

Treatment period (6 cycles) Anlotinib hydrochloride capsule: QD orally; Oxaliplatin for injection: D1 intravenous infusion on Day 1; Capecitabine tablet: BID oral administration.

Maintenance period:

Anlotinib hydrochloride capsule: QD orally; Capecitabine tablet: BID oral administration. Every 3 weeks is as one cycle, and Oxaliplatin is administered for 6 cycles. Other cases continue to be administered until the treatment termination event specified in the plan occurs.

Treatment period (6 cycles):

Bevacizumab D1 intravenous infusion; Oxaliplatin D1 intravenous infusion; Capecitabine BID oral administration.

Maintenance period:

Bevacizumab D1 intravenous infusion; Capecitabine BID oral administration. Every 3 weeks is as one cycle, and Oxaliplatin is administered for 6 cycles. Other cases continue to be administered until the treatment termination event specified in the plan occurs.

AK105 is programmed death 1（PD-1） monoclonal antibody

Anlotinib is small molecule multi-target tyrosine kinase inhibitor.

CapeOX is Capecitabine+Oxaliplatin. Capecitabine is a kind of fluorouracil drug, and Oxaliplatin is a kind of platinum anticancer drug.

CapeOX

Bevacizumab is a recombinant human monoclonal antibody.

Jin Li, Doctor

Zhonghua Chu, Doctor

Zhong Xie, Doctor

Yuxian Bai, Doctor

Jun Yao, Doctor

Zhenyang Liu, Doctor

Xizhi Zhang, Doctor

Ying Cheng, Doctor

Bo Liu, Doctor

A clinical study to compare the efficacy and safety of AK105 plus anlotinib and Capecitabine/Oxaliplatin (CapeOx) , anlotinib plus CapeOx, bevacizumab plus CapeOx. A total of 120 cases will be enrolled to the group.

A Clinical Study to Compare the Efficacy and Safety of AK105 Plus Anlotinib and Capecitabine/Oxaliplatin (CapeOx) , Anlotinib Plus CapeOx, Bevacizumab Plus CapeOx

A Multi-center, Randomized, Open-label Phase II Clinical Study to Evaluate the Efficacy and Safety of AK105 Plus Anlotinib and CapeOx, Anlotinib in Combination With CapeOx Versus Bevacizumab in Combination With CapeOx in the Fisrt-line Treatment of Unresectable Metastatic Colorectal Cancer

According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the time between the beginning of randomization and the first occurrence of objective disease progression or recurrence or death from various causes (whichever occurs first).

Refers to the time between random grouping and death caused by various causes.

Percentage of subjects with complete remission (CR) or partial remission (PR) as determined by RECIST 1.1.

Percentage of subjects with CR, PR, or disease stabilization (SD) at 6 weeks or more as determined by RECIST 1.1.

For subjects whose best remission is CR or PR, it is defined as from the date when tumor remission is first recorded to the date when disease progression is first recorded or the date of death from any cause (whichever occurs first).

Carcinoma, Hepatocellular

Liver Neoplasms

Liver Diseases

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

AK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus Anlotinib capsules 10mg 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).

Sorafenib Tosylate Tablets 400mg given orally, twice daily in 21-day cycle.

AK105 200mg intravenously (IV) on day 1 of each 21-day cycle.

AK105 Injection

Anlotinib capsules 10mg 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).

Anlotinib Hydrochloride Capsules

Sorafenib Tosylate Tablets

Jia Fan, Doctor

Rui Wang, Master

Weidong Jia, Doctor

Hu Liu, Doctor

Jinglong Chen, Master

Bin Xu, Doctor

Chunyi Hao, Doctor

Haitao Zhao, Doctor

Shunchang Jiao, Master

Yuewei Zhang, Doctor

Jianjun Leng, Doctor

Hong Ren, Master

Shangeng Weng, Doctor

Wenchang Yu, Doctor

Xiaorong Mao, Doctor

Wenhua Zhang

Minshan Chen, Doctor

Zhixiang Jian, Doctor

Wenbo Guo, Doctor

Yajin Chen, Doctor

Bangde Xiang, Doctor

Jie Ma, Doctor

Jinfang Zheng, Doctor

Sichen Wei, Master

Yuemin Nan, Doctor

Shundong Cang, Doctor

Hailiang Li, Doctor

Zhiming Wang, Doctor

Shanzhi Gu, Master

Zhiqiang Meng, Doctor

Jian Zhou, Doctor

Zhenggang Ren, Doctor

Shuangsuo Dang, Doctor

Jianqi Lian, Doctor

Wei Yang, Doctor

Qinyang Zhang, Bachelor

Jianrong Wu, Bachelor

Tianqiang Song, Doctor

Tao Han, Doctor

Yamin Zhang, Doctor

Jia Li, Doctor

Xiaobo Lu, Doctor

This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus Sorafenib. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or Sorafenib, with 2:1 random ratio. Every 21 days is a treatment cycle.

A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

OS defined as the time from the first dose 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Anlotinib Hydrochloride Capsule Combined With AK105 Injection in Subject With Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma	NCT04385550	Advanced Gastri...	Anlotinib hydro... AK105 injection Paclitaxel inje... Docetaxel injec...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Study to Compare the Efficacy and Safety of AK105 Plus Anlotinib and Capecitabine/Oxaliplatin (CapeOx) , Anlotinib Plus CapeOx, Bevacizumab Plus CapeOx	NCT05068206	Unresectable Me...	AK105 injection Anlotinib hydro... CapeOX Bevacizumab	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)	NCT04344158	Advanced Hepato...	AK105 Injection Anlotinib Hydro... Sorafenib Tosyl...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)	NCT04344158	Advanced Hepato...	AK105 Injection Anlotinib Hydro... Sorafenib Tosyl...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for ak105 injection