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Clinical Trials in China / NCT07165951
Recruiting Phase 3

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)

NCT07165951 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
Phase
Phase 3
Started
2025-12-02
Last updated
2026-05-29

Condition(s) studied

Metastatic Pancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

TQB2868 InjectionAnlotinib Hydrochloride CapsulesGemcitabine Hydrochloride InjectionPaclitaxel for InjectionTQB2868 Placebo

TQB2868 Injection: TQB2868 injection: PD-L1 and Transforming Growth Factor-beta (TGF - β) dual antibody

Anlotinib Hydrochloride Capsules: Anlotinib Hydrochloride Capsules

Gemcitabine Hydrochloride Injection: Gemcitabine Hydrochloride Injection

Paclitaxel for Injection: Paclitaxel for Injection

TQB2868 Placebo: TQB2868 Placebo without drug substance

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. The subjects voluntarily joined this study, signed the Informed Consent Form (ICF), and showed good compliance; 2. On the date of signing the ICF, aged between 18 and 75 years old (inclusive); 3. Pancreatic ductal adenocarcinoma (PDAC) diagnosed by tissue or cytology; 4. 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; 5. 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; Exclusion Criteria: 1. Have had or currently have other malignant tumors within the past 5 years prior to the first use of medication; 2. 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); 3. 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; 4. 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; 5. Subjects who experience any bleeding or bleeding events ≥ NCI CTCAE v5.0 grade 3 within 4 weeks prior to the first administration; 6. 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); 7. 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; 8. Active syphilis infected individuals who require treatment; 9. History of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, radiation pneumonitis requiring treatment, or clinically symptomatic active pneumonia; 10. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 11. Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation; 12. Subjects with any severe and/or uncontrolled illnesses; 13. 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); 14. Tumor related symptoms are difficult to control; 15. Known to be allergic to the components of research drug excipients; 16. Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication; 17. 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.

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
The First Affiliated Hospital of USTC Anhui Provincial Hospital Hefei Anhui Not Yet Recruiting
Anhui Provincial Cancer Hospital Hefei Anhui Not Yet Recruiting
Peking University First Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing Friendship Hospital,Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
The Fifth Medical Center of Chinese People's Liberation Army General Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing Daxing District People'S Hospital Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Not Yet Recruiting
Mengchao Hepatobiliary Hospital OF Fujian Medical University Fuzhou Fujian Not Yet Recruiting
The Firstaffiliated Hospital of Xiamen University Xiamen Fujian Not Yet Recruiting
Zhongshan Hospital Xiamen University Xiamen Fujian Not Yet Recruiting
Gansu Provincial Hospital Lanzhou Gansu Not Yet Recruiting
The First Hospital of Lanzhou University Lanzhou Gansu Not Yet Recruiting
Lanzhou University Second Hospital Lanzhou Gansu Not Yet Recruiting
Sun Yat-Sen University Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Not Yet Recruiting
Sun Yat-Sen University Cancer Center Guangzhou Guangdong Not Yet Recruiting
Longhua District Central Hospital Shenzhen Guangdong Not Yet Recruiting
Guangxi Cancer Institute Nanning Guangxi Not Yet Recruiting
Guizhou Medical University Affiliated Cancer Hospital Co., LTD Guiyang Guizhou Not Yet Recruiting
Affiliated Hospital of Zunyi Medical Universityl Zunyi Guizhou Not Yet Recruiting
Hainan general hospital Haikou Hainan Not Yet Recruiting
Cancer Hospital Chinese Academy pf Medical Sciences Langfang Hebei Not Yet Recruiting
Tangshan peopel's Hospital Tangshan Hebei Not Yet Recruiting
Daqing Oilfield General Hospital Daqing Heilongjiang Not Yet Recruiting
Harbin Medical University Cancer Hospital Haerbin Heilongjiang Not Yet Recruiting
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan Not Yet Recruiting
Henan Cancer Hospital Zhengzhou Henan Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Not Yet Recruiting
Zhongnan Hospital of Wuhan University Wuhan Hubei Not Yet Recruiting
Hubei Cancer Hospital Wuhan Hubei Not Yet Recruiting
Xiangyang Central Hospital Xiangyang Hubei Not Yet Recruiting
Hunan Cancer Hospital Changsha Hunan Not Yet Recruiting
People's Hospital of Hunan Province Changsha Hunan Not Yet Recruiting
Xiangya Hospital of Central South University Changsha Hunan Recruiting
Peking University Cancer Hospital Inner Mongolia Hospital Hohhot Inner Mongolia Not Yet Recruiting
Jiangyin People'S Hospital Jiangyin Jiangsu Not Yet Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Not Yet Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Not Yet Recruiting
Nantong Tumor Hospital Nantong Jiangsu Not Yet Recruiting
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Not Yet Recruiting

+ 31 more sites — see the full list on the official registry below.

More Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07165951 on ClinicalTrials.gov ↗ ← All trials in China