Actively Recruiting
A Randomized, Double-blind, Parallel-controlled, Multicenter Phase III Trial Comparing TQB2868 Injection Plus Anlotinib Hydrochloride Capsules to Placebo Plus Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma
Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2026-05-29
566
Participants Needed
71
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for metastatic pancreatic ductal adenocarcinoma (mPDAC) in this randomized, double-blind, placebo-controlled, multicenter phase III clinical trial. The study aims to compare overall survival between patients receiving a combination of TQB2868 injection, anlotinib hydrochloride capsules, and chemotherapy versus those receiving placebo combined with chemotherapy. This trial evaluates whether adding TQB2868, a dual antibody targeting PD-L1 and TGF-beta, to standard treatment may impact survival outcomes in patients with advanced pancreatic cancer. Participants are randomly assigned to one of two groups. The experimental group receives TQB2868 injection plus anlotinib hydrochloride capsules combined with gemcitabine hydrochloride injection and paclitaxel for injection. The control group receives a placebo injection combined with anlotinib hydrochloride capsules and the same chemotherapy drugs. Treatments are given as first-line therapy for metastatic disease, with dosing and administration schedules based on the trial protocol. The study includes an approximately two-year period for measuring overall survival as the primary outcome. During the trial, participants will undergo regular assessments including imaging scans to evaluate tumor response, laboratory tests, and monitoring for adverse events. Secondary outcomes include progression-free survival, objective response rate, disease control rate, duration of response, and time to tumor recurrence, observed over about one year. Safety is closely monitored until 28 days after the last treatment. The total participation time varies depending on individual outcomes and follow-up schedules.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old (inclusive)
- Diagnosed with pancreatic ductal adenocarcinoma by tissue or cytology
- Stage IV metastatic pancreatic cancer according to AJCC 8th Edition TNM system
- No prior systemic anti-tumor or investigational drug therapy; at least 6 months since last neoadjuvant/adjuvant therapy if given
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Expected survival greater than 12 weeks
- Laboratory tests meeting protocol standards
- Women of childbearing age and men agree to use effective contraception during and for 6 months after the study
- Provided informed consent and demonstrate good compliance
You will not qualify if you...
- History of other malignant tumors within 5 years before first medication
- Conditions affecting intravenous injection, venous blood collection, or oral medication
- Unresolved adverse reactions from prior treatments above NCI CTCAE v5.0 grade 1, except some non-safety risks
- Recent major surgery, trauma, or untreated wounds/fractures within 4 weeks before first medication
- Bleeding events of grade 3 or higher within 4 weeks before first administration
- Arterial or venous thrombotic events within 6 months prior to first administration
- HBV infection without regular antiviral treatment or unstable HCV infection requiring treatment
- Active syphilis infection requiring treatment
- History of active pulmonary tuberculosis or other serious lung conditions
- History of psychotropic drug abuse or mental disorders unable to quit
- Previous or planned allogeneic bone marrow or solid organ transplantation
- Severe or uncontrolled illnesses
- Need for immunosuppressive therapy or systemic steroid use above allowed dose within 7 days before first dose
- Uncontrolled tumor-related symptoms
- Known allergies to study drug components
- Participation in other anti-tumor clinical trials within 4 weeks before first medication
- Pregnant or breastfeeding
- Any serious condition threatening safety or study completion as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants receive either TQB2868 Injection combined with Anlotinib Hydrochloride Capsules and chemotherapy, or placebo combined with Anlotinib Hydrochloride Capsules and chemotherapy as first-line treatment for metastatic pancreatic ductal adenocarcinoma.
Visits occur according to treatment cycles and assessments throughout treatment
Duration - Up to approximately 1 year after treatment
Participants are monitored for safety and overall survival after treatment ends, including adverse event assessments up to 28 days after the last medication administration.
Follow-up visits as scheduled until study completion
Trial Site Locations
Total: 71 locations
1
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
Not Yet Recruiting
3
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Not Yet Recruiting
4
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100050
Not Yet Recruiting
5
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China, 100071
Not Yet Recruiting
6
Beijing Daxing District People'S Hospital
Beijing, Beijing Municipality, China, 102699
Not Yet Recruiting
7
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
8
Mengchao Hepatobiliary Hospital OF Fujian Medical University
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
9
The Firstaffiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361001
Not Yet Recruiting
10
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361001
Not Yet Recruiting
11
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
12
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
13
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
Not Yet Recruiting
14
Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
15
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510030
Not Yet Recruiting
16
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510062
Not Yet Recruiting
17
Longhua District Central Hospital
Shenzhen, Guangdong, China, 518000
Not Yet Recruiting
18
Guangxi Cancer Institute
Nanning, Guangxi, China, 530000
Not Yet Recruiting
19
Guizhou Medical University Affiliated Cancer Hospital Co., LTD
Guiyang, Guizhou, China, 550001
Not Yet Recruiting
20
Affiliated Hospital of Zunyi Medical Universityl
Zunyi, Guizhou, China, 563000
Not Yet Recruiting
21
Hainan general hospital
Haikou, Hainan, China, 570311
Not Yet Recruiting
22
Cancer Hospital Chinese Academy pf Medical Sciences
Langfang, Hebei, China, 065000
Not Yet Recruiting
23
Tangshan peopel's Hospital
Tangshan, Hebei, China, 063001
Not Yet Recruiting
24
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China, 163001
Not Yet Recruiting
25
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China, 150000
Not Yet Recruiting
26
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 471000
Not Yet Recruiting
27
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
28
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
29
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Not Yet Recruiting
30
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Not Yet Recruiting
31
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
Not Yet Recruiting
32
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
33
People's Hospital of Hunan Province
Changsha, Hunan, China, 410005
Not Yet Recruiting
34
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Actively Recruiting
35
Peking University Cancer Hospital Inner Mongolia Hospital
Hohhot, Inner Mongolia, China, 10000
Not Yet Recruiting
36
Jiangyin People'S Hospital
Jiangyin, Jiangsu, China, 214431
Not Yet Recruiting
37
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
38
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
39
Nantong Tumor Hospital
Nantong, Jiangsu, China, 226361
Not Yet Recruiting
40
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Not Yet Recruiting
41
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221004
Not Yet Recruiting
42
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
43
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Not Yet Recruiting
44
The first hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
45
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
46
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110801
Not Yet Recruiting
47
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, Shaanxi, China, 710038
Not Yet Recruiting
48
The First Affiliated Hospital of Xi 'An Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
49
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
50
Linyi people's hospital
Linyi, Shandong, China, 276000
Not Yet Recruiting
51
Linyi Cancer Hospital
Liyi, Shandong, China, 276034
Not Yet Recruiting
52
The Affiliated Hospital Of Medical College Qingdao University
Qingdao, Shandong, China, 266000
Not Yet Recruiting
53
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
54
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
55
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Not Yet Recruiting
56
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 201620
Not Yet Recruiting
57
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
58
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030045
Not Yet Recruiting
59
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
60
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Not Yet Recruiting
61
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China, 637000
Not Yet Recruiting
62
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300300
Not Yet Recruiting
63
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300300
Not Yet Recruiting
64
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
65
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China, 650000
Not Yet Recruiting
66
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
67
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
68
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 311000
Not Yet Recruiting
69
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315100
Not Yet Recruiting
70
Shaoxing People's Hospital
Shaoxing, Zhejiang, China, 312000
Not Yet Recruiting
71
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
X
Xianjun Yu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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