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 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)
1 other identifier
interventional
566
1 country
70
Brief 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 chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2025
Typical duration for phase_3
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2025
CompletedFirst Posted
Study publicly available on registry
September 10, 2025
CompletedStudy Start
First participant enrolled
December 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
December 24, 2025
June 1, 2025
2.4 years
September 3, 2025
December 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Progression-Free Survival evaluated by researchers
The duration is approximately 1 year
Objective Response Rate evaluated by researchers
The duration is approximately 1 year
The Disease Control Rate evaluated by the researchers
The duration is approximately 1 year
The Duration of Response (DOR) evaluated by the researchers
The duration is approximately 1 year
The Time to Tumor Recurrence evaluated by the researchers
The duration is approximately 1 year
- +1 more secondary outcomes
Study Arms (2)
TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapy
EXPERIMENTALTQB2868 Injection+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection
TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapy
PLACEBO COMPARATORTQB2868 Placebo+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection
Interventions
TQB2868 injection: PD-L1 and Transforming Growth Factor-beta (TGF - β) dual antibody
Anlotinib Hydrochloride Capsules
Gemcitabine Hydrochloride Injection
Paclitaxel for Injection
TQB2868 Placebo without drug substance
Eligibility Criteria
You may qualify if:
- 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;
- \. 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;
You may not qualify if:
- 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);
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050, China
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100071, China
Beijing Daxing District People'S Hospital
Beijing, Beijing Municipality, 102699, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Mengchao Hepatobiliary Hospital OF Fujian Medical University
Fuzhou, Fujian, 350001, China
The Firstaffiliated Hospital of Xiamen University
Xiamen, Fujian, 361001, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361001, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Sun Yat-Sen University
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510030, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510062, China
Longhua District Central Hospital
Shenzhen, Guangdong, 518000, China
Guangxi Cancer Institute
Nanning, Guangxi, 530000, China
Guizhou Medical University Affiliated Cancer Hospital Co., LTD
Guiyang, Guizhou, 550001, China
Affiliated Hospital of Zunyi Medical Universityl
Zunyi, Guizhou, 563000, China
Hainan general hospital
Haikou, Hainan, 570311, China
Cancer Hospital Chinese Academy pf Medical Sciences
Langfang, Hebei, 065000, China
Tangshan peopel's Hospital
Tangshan, Hebei, 063001, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001, China
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
People's Hospital of Hunan Province
Changsha, Hunan, 410005, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Peking University Cancer Hospital Inner Mongolia Hospital
Hohhot, Inner Mongolia, 10000, China
Jiangyin People'S Hospital
Jiangyin, Jiangsu, 214431, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226361, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The first hospital of Jilin University
Changchun, Jilin, 130000, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110801, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, Shaanxi, 710038, China
The First Affiliated Hospital of Xi 'An Jiaotong University
Xi'an, Shaanxi, 710061, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Linyi people's hospital
Linyi, Shandong, 276000, China
Linyi Cancer Hospital
Liyi, Shandong, 276034, China
The Affiliated Hospital Of Medical College Qingdao University
Qingdao, Shandong, 266000, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200030, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 201620, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030045, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300300, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300300, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, 311000, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315100, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000, China
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2025
First Posted
September 10, 2025
Study Start
December 2, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
December 24, 2025
Record last verified: 2025-06