Metastatic Pancreatic Ductal AdenocarcinomaPhase 3NCT07165951
Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
A Phase 3 study testing TQB2868 Injection, Anlotinib Hydrochloride Capsules and Gemcitabine Hydrochloride Injection in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 71 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- TQB2868 Injection, Anlotinib Hydrochloride Capsules and Gemcitabine Hydrochloride Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 566 participants
- Where
- 71 sitesChina
- Study dates
- 2 Dec 2025to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joined this study, signed the Informed Consent Form (ICF), and showed good compliance;
- On the date of signing the ICF, aged between 18 and 75 years old (inclusive);
- Pancreatic ductal adenocarcinoma (PDAC) diagnosed by tissue or cytology;
- According to the American Joint Commission on Cancer (AJCC) 8th Edition Tumor, Node, Metastasis (TNM) staging system for pancreatic cancer, patients with stage IV metastatic pancreatic cancer;
- Have not received any systemic anti-tumor treatment or investigational drug therapy; If receiving neoadjuvant/adjuvant therapy, the time interval between the last administration and recurrence/progression must be ≥ 6 months, and the toxicity related to anti-tumor therapy has recovered to ≤ level 1 or the toxicity level specified in the inclusion criteria (excluding hair loss); According to RECIST v1.1, there is at least one measurable lesion. If the lesion has undergone local treatment (radiotherapy, ablation, interventional therapy, etc.) in the past, it must be clearly proven to have progressed in accordance with RECIST v1.1 before it can be considered a measurable lesion;
- 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;
Who cannot join
- Have had or currently have other malignant tumors within the past 5 years prior to the first use of medication;
- There are various factors that affect intravenous injection, venous blood collection diseases, or oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- Adverse reactions from previous treatments have not recovered to NCI CTCAE v5.0 score ≤ 1, except for toxicity that has been determined by researchers to have no safety risks, such as grade 2 hair loss, grade 2 peripheral neurotoxicity, non clinically significant, and asymptomatic laboratory abnormalities;
- Those who have received major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks before the first medication, or have long-term untreated wounds or fractures;
- Subjects who experience any bleeding or bleeding events ≥ NCI CTCAE v5.0 grade 3 within 4 weeks prior to the first administration;
- Individuals who have experienced arterial/venous thrombotic events within 6 months prior to the first administration, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, or any other history of severe thromboembolism (implantable venous infusion port or catheter-related thrombosis, or superficial vein thrombosis is not considered "severe" thromboembolism);
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- hepatitis B virus (HBV) infected individuals cannot receive regular antiviral treatment throughout the entire process; HCV infected individuals (HCV Ab or HCV RNA positive): Researchers determine that they are in an unstable state or need to continue antiviral treatment. Regular antiviral treatment cannot be accepted during the study;
- Active syphilis infected individuals who require treatment;
- History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia;
- Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
- Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;
- Subjects with any severe and/or uncontrolled illnesses;
- Subjects who require immunosuppressive therapy, systemic or absorbable local hormone therapy to achieve immunosuppression and continue to use it within 7 days prior to the first dose (excluding corticosteroids with a daily dose of<10 mg prednisone or other therapeutic hormones);
- Tumor related symptoms are difficult to control;
- Known to be allergic to the components of research drug excipients;
- Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;
- Pregnant or breastfeeding subjects; According to the judgment of the researchers, there are serious situations that pose a threat to the safety of the subjects or affect their ability to complete the study.
Trial locations and contacts
71 sites in 1 country. Contact the study team or a site near you to ask about taking part.
71 sites in 1 country
China71 sites, 71 recruiting
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Shikai Wu, Doctor, 15810037303, skywu4923@sina.com
- Not yet recruiting
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050
Wei Deng, Doctor, 13426136152, dengweiwei@126.com
- Not yet recruiting
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100071
Guanghai Dai, Doctor, 13801232381, daigh301@vip.sina.com
- Not yet recruiting
Beijing Daxing District People'S Hospital
Beijing, Beijing Municipality, 102699
Qing Li, Doctor, 13701288153, qinli128003@163.com
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
Lixia Ma, Master, 13578670958, 13578670958@163.com
- Not yet recruiting
The first hospital of Jilin University
Changchun, Jilin, 130000
Yuguang Zhao, Doctor, 15804303822, zhaohuan81@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Zhenyang Liu, Master, 18673181133, 18673181133@163.com
- Not yet recruiting
People's Hospital of Hunan Province
Changsha, Hunan, 410005
Huaxin/ Duan, Doctor, 13347315509, 317102912@qq.com
Yi Liu, Doctor, 13077383585, liuyi0802@hunnu.edu.cn
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Xuejun Gong, Doctor, 13974870421, peigong158@csu.edu.cn
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Xielin Feng, Doctor, 18908173272, llxxff@163.com
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Yong Chen, Doctor, 13883001073, doctorcy007@163.com
- Not yet recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001
Liangyu Zhang, Doctor, 13359812997, hdfi8d@sina.com
- Not yet recruiting
Mengchao Hepatobiliary Hospital OF Fujian Medical University
Fuzhou, Fujian, 350001
Xiong Chen, Doctor, 13625082108, Zpccx81@163.com
- Not yet recruiting
Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Zhihua Li, Bachelor, 13710818805, lzhdoct@163.com
- Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510030
Guoying Wang, Doctor, 13632407313, wanggy3@126.com
- Not yet recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510062
Feng Wang, Doctor, 18620880867, wangfeng@sysucc.org.cn
- Not yet recruiting
Guizhou Medical University Affiliated Cancer Hospital Co., LTD
Guiyang, Guizhou, 550001
Yaozhen Pan, Doctor, 18984389506, panyaozhen112@163.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150000
Zhiwei Li, Doctor, 15004683651, lzhwo0451@163.com
- Not yet recruiting
Hainan general hospital
Haikou, Hainan, 570311
Yanjing Huang, Doctor, 13888025075, zhayong888@sina.com
- Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Yuan Ding, Doctor, 18858101960, dingyuan@zju.edu.cn
- Not yet recruiting
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, 311000
Hong Yu, Doctor, 13605705907, blueyu000@zju.edu.cn
- Not yet recruiting
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, 230001
Juan Cai, Doctor, 18375330952, caijuan1987@yeah.ne
- Not yet recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
Yifu He, Doctor, 18963789042, 834638033@qq.com
- Not yet recruiting
Peking University Cancer Hospital Inner Mongolia Hospital
Hohhot, Inner Mongolia, 10000
Xiaotian Zhang, Doctor, 13810995536, zhangxiaotianmed@163.com
- Not yet recruiting
Jiangyin People'S Hospital
Jiangyin, Jiangsu, 214431
Qiong Wang, Doctor, 15861484311, wangqiong55@hotmail.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Lei Wang, Doctor, 13605313603, qlwanglei1102@163.com
Jiang Hao, Doctor, 18560082857, hedi0084@hotmail.com
- Not yet recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000
Chao Dong, Doctor, 13211607680, dcayy_2008@163.com
- Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Yong Zha, Doctor, 13888025075, zhayong888@sina.com
- Not yet recruiting
Cancer Hospital Chinese Academy pf Medical Sciences
Langfang, Hebei, 065000
Yongkun Sun, Doctor, 13141276041, hsunyk@126.com
- Not yet recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
Mingxu Da, Doctor, 15095321201, Hxdamingxu1968@hotmail.com
Xiaojun Yang, Doctor, 18993113172, yangxjmd@aliyun.com
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Wenbo Meng, Doctor, 13919177177, mengwb@163.com
Shoucheng Ma, Master, 13893453504, 1054763332@qq.com
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Wence Zhou, Doctor, 13893699909, Zhouwc129@163.com
- Not yet recruiting
Linyi people's hospital
Linyi, Shandong, 276000
Zhongmin Zhang, Master, 13853912929, rtog@163.com
- Not yet recruiting
Linyi Cancer Hospital
Liyi, Shandong, 276034
Zhen Li, Bachelor, 13869908100, lizhensdly@126.com
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000
Jun Yao, Doctor, 13663790098, yaojun74@163.com
- Not yet recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Li Xiang, Doctor, 13882728599, xl790927@sina.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yong Li, Doctor, 15879155066, liyongcsco@qq.com
- Not yet recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Yan Gui, Master, 15882618827, 15882618827@163.com
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000
Juan Du, Doctor, 13951826526, dujuanglyy@163.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Kuirong Jiang, Doctor, 15312995688, jiangkuirong@163.com
- Not yet recruiting
Guangxi Cancer Institute
Nanning, Guangxi, 530000
Feixiang Wu, Doctor, 137 0787 3326, wufx2013@163.com
- Not yet recruiting
Nantong Tumor Hospital
Nantong, Jiangsu, 226361
Aibing Xu, Bachelor, 13806298983, liurui9092@aliyun.com
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315100
Yongfei Hua, Doctor, 13095951515, lhlhuayongfei@nbu.edu.cn
- Not yet recruiting
The Affiliated Hospital Of Medical College Qingdao University
Qingdao, Shandong, 266000
Jingyu Cao, Doctor, 18661809587, cjy7027@163.com
- Not yet recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200030
Yuehong Cui, Doctor, 13916912156, cui.yuehong@zs-hospital.sh.cn
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, Doctor, 13801669875, yxj@163.com
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Jun Yan, Doctor, 18930172345, shanghaijunyan007@163.com
- Not yet recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 201620
Jiang Long, Doctor, 18017317460, jiang.long@shgh.cn
- Not yet recruiting
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000
Baochun Lu, Master, 13002638081, lbc111@yeah.net
- Not yet recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000
Yefu Liu, Doctor, 13386836868, 979021153@cmu.edu.cn
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110801
Jinglei Qu, Doctor, 15904058133, qujinglei@hotmail.com
- Not yet recruiting
Longhua District Central Hospital
Shenzhen, Guangdong, 518000
Xiaonhong Liu, Doctor, 13972065126, 723303637@qq.com
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Wei Li, Doctor, 15895401045, liwei10@suda.edu.cn
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
Mudan Yang, Master, 13803433331, yangmd6000@163.com
Hongxia Lu, Master, 17735165937, 53473139@qq.com
- Not yet recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030045
Yusheng Wang, Doctor, 13834646436, wangyusheng1972@163.com
- Not yet recruiting
Tangshan peopel's Hospital
Tangshan, Hebei, 063001
Zhiwu Wang, Doctor, 18931506162, tcm2000@163.com
- Not yet recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300300
Huikai Li, Doctor, 18622228639, tjchlhk@126.com
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300300
Ting Deng, Doctor, 15802243063, xymcdengting@126.com
- Not yet recruiting
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000
Jiang Liu, Master, 13999822688, Liujiang@medmail.com.cn
Xiong Chen, Master, 13565852575, nhcx123@126.com
- Not yet recruiting
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, 325000
Gang Chen, Doctor, 13616619566, cg_2188@126.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Jin Peng, Doctor, 13971235235, pjxp888@126.com
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Dongde Wu, Doctor, 15629019627, 971070316@qq.com
- Not yet recruiting
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, Shaanxi, 710038
Dong Wang, Doctor, 15509186180, wdyt021@126.com
- Not yet recruiting
The First Affiliated Hospital of Xi 'An Jiaotong University
Xi'an, Shaanxi, 710061
Zheng Wu, Doctor, 13609195898, woozheng@xjtu.edu.cn
- Not yet recruiting
The Firstaffiliated Hospital of Xiamen University
Xiamen, Fujian, 361001
Feng Ye, Doctor, 13860458889, yefengdoctor@sina.com
- Not yet recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361001
Zhenyu Yin, Doctor, 13950120518, yinzy@xmu.edu.cn
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Wei Gong, Doctor, 13597483320, gongzhewei@sina.com
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004
Wenxing Zhao, Bachelor, 18052268377, WXZHAO@sina.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Xiaobin Chen, Doctor, 13937100233, 2290773710@qq.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yongxu Jia, Doctor, 15237128281, Jiayongxu111@126.co
- Not yet recruiting
Affiliated Hospital of Zunyi Medical Universityl
Zunyi, Guizhou, 563000
Rongshu Shi, Bachelor, 13985263013, shirongshujieru@163.com
About this study
Official title: A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules to Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
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.
- Being tested
- TQB2868 Injection, Anlotinib Hydrochloride Capsules, Gemcitabine Hydrochloride Injection, Paclitaxel for Injection, TQB2868 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2868 InjectionDrug
TQB2868 injection: PD-L1 and Transforming Growth Factor-beta (TGF - β) dual antibody
Anlotinib Hydrochloride CapsulesDrug
Anlotinib Hydrochloride Capsules
Gemcitabine Hydrochloride InjectionDrug
Gemcitabine Hydrochloride Injection
Paclitaxel for InjectionDrug
Paclitaxel for Injection
TQB2868 PlaceboDrug
TQB2868 Placebo without drug substance
| Study group | Role | What they receive |
|---|---|---|
| TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapy | Experimental | TQB2868 Injection+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection Receives: Drug: TQB2868 Injection; Drug: Anlotinib Hydrochloride Capsules; Drug: Gemcitabine Hydrochloride Injection; Drug: Paclitaxel for Injection |
| TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapy | Placebo comparator | TQB2868 Placebo+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection Receives: Drug: Anlotinib Hydrochloride Capsules; Drug: Gemcitabine Hydrochloride Injection; Drug: Paclitaxel for Injection; Drug: TQB2868 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The duration is approximately 2 years
Secondary outcomes (6)
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.
Measured: The duration is approximately 1 year
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Sign the informed consent form, and until 28 days after the last medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start2 Dec 2025
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 566 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165951
- Sponsor's protocol ID
- TQB2868-ALTN-III-01
- Status last verified
- Jun 2025
- First submitted
- 3 Sep 2025
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules to Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
- ClinicalTrials.gov ID
- NCT07165951
- Acronym / sponsor ID
- TQB2868-ALTN-III-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapy | Experimental | Drug: TQB2868 Injection, Drug: Anlotinib Hydrochloride Capsules, Drug: Gemcitabine Hydrochloride Injection, Drug: Paclitaxel for InjectionTQB2868 Injection+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection |
| TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapy | Placebo comparator | Drug: Anlotinib Hydrochloride Capsules, Drug: Gemcitabine Hydrochloride Injection, Drug: Paclitaxel for Injection, Drug: TQB2868 PlaceboTQB2868 Placebo+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subjects voluntarily joined this study, signed the Informed Consent Form (ICF), and showed good compliance;
- On the date of signing the ICF, aged between 18 and 75 years old (inclusive);
- Pancreatic ductal adenocarcinoma (PDAC) diagnosed by tissue or cytology;
- According to the American Joint Commission on Cancer (AJCC) 8th Edition Tumor, Node, Metastasis (TNM) staging system for pancreatic cancer, patients with stage IV metastatic pancreatic cancer;
- Have not received any systemic anti-tumor treatment or investigational drug therapy; If receiving neoadjuvant/adjuvant therapy, the time interval between the last administration and recurrence/progression must be ≥ 6 months, and the toxicity related to anti-tumor therapy has recovered to ≤ level 1 or the toxicity level specified in the inclusion criteria (excluding hair loss); According to RECIST v1.1, there is at least one measurable lesion. If the lesion has undergone local treatment (radiotherapy, ablation, interventional therapy, etc.) in the past, it must be clearly proven to have progressed in accordance with RECIST v1.1 before it can be considered a measurable lesion;
Key exclusion criteria (17 listed)
- Have had or currently have other malignant tumors within the past 5 years prior to the first use of medication;
- There are various factors that affect intravenous injection, venous blood collection diseases, or oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- Adverse reactions from previous treatments have not recovered to NCI CTCAE v5.0 score ≤ 1, except for toxicity that has been determined by researchers to have no safety risks, such as grade 2 hair loss, grade 2 peripheral neurotoxicity, non clinically significant, and asymptomatic laboratory abnormalities;
- Those who have received major surgical treatment, significant traumatic injury, or are expected to undergo major surgery during the expected study treatment period within 4 weeks before the first medication, or have long-term untreated wounds or fractures;
- Subjects who experience any bleeding or bleeding events ≥ NCI CTCAE v5.0 grade 3 within 4 weeks prior to the first administration;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2868 InjectionTQB2868 injection: PD-L1 and Transforming Growth Factor-beta (TGF - β) dual antibody | Drug | TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapy |
| Anlotinib Hydrochloride CapsulesAnlotinib Hydrochloride Capsules | Drug | TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapy, TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapy |
| Gemcitabine Hydrochloride InjectionGemcitabine Hydrochloride Injection | Drug | TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapy, TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapy |
| Paclitaxel for InjectionPaclitaxel for Injection | Drug | TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapy, TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapy |
| TQB2868 PlaceboTQB2868 Placebo without drug substance | Drug | TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapy |
Primary outcome
Overall Survival
Time frame: The duration is approximately 2 years
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).
6 secondary outcomes
Progression-Free Survival evaluated by researchers
Time frame: The duration is approximately 1 year
Objective Response Rate evaluated by researchers
Time frame: The duration is approximately 1 year
The Disease Control Rate evaluated by the researchers
Time frame: The duration is approximately 1 year
The Duration of Response (DOR) evaluated by the researchers
Time frame: The duration is approximately 1 year
The Time to Tumor Recurrence evaluated by the researchers
Time frame: The duration is approximately 1 year
Adverse events
Time frame: Sign the informed consent form, and until 28 days after the last medication administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
71 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB2868 Injection, Anlotinib Hydrochloride Capsules and Gemcitabine Hydrochloride Injection in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 71 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianjun Yu, Doctor (13801669875, yxj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: The duration is approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.