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This study adopts a randomized, open label, placebo-controlled, multicenter trial design. OS was the primary endpoint, and eligible subjects were randomly divided into 1:1 groups and received TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy, compared to placebo combined with chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapy | Experimental | TQB2868 Injection+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection |
|
| TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapy | Placebo Comparator | TQB2868 Placebo+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2868 Injection | Drug | TQB2868 injection: PD-L1 and Transforming Growth Factor-beta (TGF - β) dual antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | By evaluating overall survival (OS), this study aims to demonstrate the efficacy of TQB2868 injection combined with anlotinib hydrochloride capsules in chemotherapy compared to placebo combined with chemotherapy in the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). | The duration is approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival evaluated by researchers | Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Progression-Free Survival evaluated by researchers. | The duration is approximately 1 year |
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Inclusion Criteria:
7. Eastern Cooperative Oncology Group (ECOG) score from 0 to 1; Expected survival is greater than 12 weeks; 9. The laboratory inspection meets the protocol standards; 10. Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study, and have a negative serum test within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianjun Yu, Doctor | Contact | 13801669875 | yxj@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | 230001 | China |
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| Anlotinib Hydrochloride Capsules | Drug | Anlotinib Hydrochloride Capsules |
|
| Gemcitabine Hydrochloride Injection | Drug | Gemcitabine Hydrochloride Injection |
|
| Paclitaxel for Injection | Drug | Paclitaxel for Injection |
|
| TQB2868 Placebo | Drug | TQB2868 Placebo without drug substance |
|
| Objective Response Rate evaluated by researchers | Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Objective Response Rate evaluated by researchers. | The duration is approximately 1 year |
| The Disease Control Rate evaluated by the researchers | Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Disease Control Rate evaluated by researchers. | The duration is approximately 1 year |
| The Duration of Response (DOR) evaluated by the researchers | Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Duration of Response evaluated by researchers. | The duration is approximately 1 year |
| The Time to Tumor Recurrence evaluated by the researchers | Evaluate the effectiveness of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) using the Time to Tumor Recurrence evaluated by researchers. | The duration is approximately 1 year |
| Adverse events | Evaluate the safety of TQB2868 injection and anlotinib hydrochloride capsules combined with chemotherapy compared to placebo combined with chemotherapy in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) by assessing the incidence and severity of adverse events, determined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 5.0 grading scale. | Sign the informed consent form, and until 28 days after the last medication administration |
| Anhui Provincial Cancer Hospital | Not yet recruiting | Hefei | Anhui | 230031 | China |
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| Peking University First Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Beijing Friendship Hospital,Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100050 | China |
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| The Fifth Medical Center of Chinese People's Liberation Army General Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100071 | China |
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| Beijing Daxing District People'S Hospital | Not yet recruiting | Beijing | Beijing Municipality | 102699 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| Mengchao Hepatobiliary Hospital OF Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | 350001 | China |
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| The Firstaffiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | 361001 | China |
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| Zhongshan Hospital Xiamen University | Not yet recruiting | Xiamen | Fujian | 361001 | China |
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| Gansu Provincial Hospital | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| The First Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| Lanzhou University Second Hospital | Not yet recruiting | Lanzhou | Gansu | 730030 | China |
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| Sun Yat-Sen University | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510030 | China |
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| Sun Yat-Sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510062 | China |
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| Longhua District Central Hospital | Not yet recruiting | Shenzhen | Guangdong | 518000 | China |
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| Guangxi Cancer Institute | Not yet recruiting | Nanning | Guangxi | 530000 | China |
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| Guizhou Medical University Affiliated Cancer Hospital Co., LTD | Not yet recruiting | Guiyang | Guizhou | 550001 | China |
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| Affiliated Hospital of Zunyi Medical Universityl | Not yet recruiting | Zunyi | Guizhou | 563000 | China |
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| Hainan general hospital | Not yet recruiting | Haikou | Hainan | 570311 | China |
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| Cancer Hospital Chinese Academy pf Medical Sciences | Not yet recruiting | Langfang | Hebei | 065000 | China |
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| Tangshan peopel's Hospital | Not yet recruiting | Tangshan | Hebei | 063001 | China |
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| Daqing Oilfield General Hospital | Not yet recruiting | Daqing | Heilongjiang | 163001 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Haerbin | Heilongjiang | 150000 | China |
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| The First Affiliated Hospital of Henan University of Science & Technology | Not yet recruiting | Luoyang | Henan | 471000 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| Hubei Cancer Hospital | Not yet recruiting | Wuhan | Hubei | 430079 | China |
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| Xiangyang Central Hospital | Not yet recruiting | Xiangyang | Hubei | 441021 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| People's Hospital of Hunan Province | Not yet recruiting | Changsha | Hunan | 410005 | China |
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| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| Peking University Cancer Hospital Inner Mongolia Hospital | Not yet recruiting | Hohhot | Inner Mongolia | 10000 | China |
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| Jiangyin People'S Hospital | Not yet recruiting | Jiangyin | Jiangsu | 214431 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| Nantong Tumor Hospital | Not yet recruiting | Nantong | Jiangsu | 226361 | China |
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| The First Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | 215006 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | 221004 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| Jilin Cancer Hospital | Not yet recruiting | Changchun | Jilin | 130000 | China |
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| The first hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130000 | China |
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| Liaoning Cancer Hospital | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
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| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110801 | China |
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| The Second Affiliated Hospital of PLA Air Force Military Medical University | Not yet recruiting | Xi'an | Shaanxi | 710038 | China |
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| The First Affiliated Hospital of Xi 'An Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710061 | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | 250012 | China |
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| Linyi people's hospital | Not yet recruiting | Linyi | Shandong | 276000 | China |
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| Linyi Cancer Hospital | Not yet recruiting | Liyi | Shandong | 276034 | China |
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| The Affiliated Hospital Of Medical College Qingdao University | Not yet recruiting | Qingdao | Shandong | 266000 | China |
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| Zhongshan Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Shanghai Sixth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200233 | China |
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| Shanghai General Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 201620 | China |
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| Shanxi Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 030000 | China |
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| First Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 030045 | China |
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| Sichuan Cancer Hospital | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | 646000 | China |
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| Affiliated Hospital of North Sichuan Medical College | Not yet recruiting | Nanchong | Sichuan | 637000 | China |
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| Tianjin Cancer Hospital Airport Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300300 | China |
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| Tianjin Medical University Cancer Institute & Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300300 | China |
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| People's Hospital of Xinjiang Uygur Autonomous Region | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
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| The First Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | 650000 | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | 650118 | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 311000 | China |
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| Ningbo Medical Center Lihuili Hospital | Not yet recruiting | Ningbo | Zhejiang | 315100 | China |
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| Shaoxing People's Hospital | Not yet recruiting | Shaoxing | Zhejiang | 312000 | China |
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| Wenzhou Medical University Affiliated First Hospital | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D007267 | Injections |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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