Actively Recruiting
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)
Led by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Updated on 2025-12-24
566
Participants Needed
70
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Subjects voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years old inclusive
- Diagnosis of pancreatic ductal adenocarcinoma confirmed by tissue or cytology
- Stage IV metastatic pancreatic cancer according to AJCC 8th Edition TNM system
- No prior systemic anti-tumor or investigational drug treatment; if prior neoadjuvant/adjuvant therapy, at least 6 months since last administration and toxicity recovered to acceptable levels
- At least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status score of 0 to 1
- Expected survival longer than 12 weeks
- Laboratory tests meet protocol standards
- Women of childbearing potential must use effective contraception during study and for 6 months after, with negative serum pregnancy test within 7 days prior to enrollment
- Men must agree to use effective contraception during study and for 6 months after
You will not qualify if you...
- History or current other malignant tumors within 5 years prior to first medication
- Conditions affecting intravenous injection, venous blood collection, or oral medication intake
- Unresolved adverse reactions from previous treatments above certain severity levels, except certain specified toxicities
- Major surgery, significant trauma, or long-term untreated wounds/fractures within 4 weeks before first medication
- Severe bleeding events within 4 weeks prior to first administration
- Arterial or venous thrombotic events within 6 months before first administration
- Hepatitis B or unstable hepatitis C infection requiring antiviral treatment during study
- Active syphilis infection requiring treatment
- History of active pulmonary infections or symptomatic pneumonia
- History of psychotropic drug abuse or mental disorders preventing participation
- Previous allogeneic bone marrow or solid organ transplantation
- Severe or uncontrolled illnesses
- Need for immunosuppressive therapy or certain hormone treatments within 7 days before first dose
- Tumor-related symptoms difficult to control
- Known allergy to components of study drugs
- Participation in other anti-tumor clinical trials within 4 weeks prior to first medication
- Pregnancy or breastfeeding
- Other serious conditions judged by researchers to threaten safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 70 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
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
66
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
67
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 311000
Not Yet Recruiting
68
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315100
Not Yet Recruiting
69
Shaoxing People's Hospital
Shaoxing, Zhejiang, China, 312000
Not Yet Recruiting
70
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
X
Xianjun Yu, Doctor
CONTACT
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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