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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

NCT07165951•Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
•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;
+7 more criteria

Locations (70)

The First Affiliated Hospital of USTC Anhui Provincial Hospital

Hefei, Anhui, China

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Peking University First Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, China

The Fifth Medical Center of Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Beijing Daxing District People'S Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Mengchao Hepatobiliary Hospital OF Fujian Medical University

Fuzhou, Fujian, China

The Firstaffiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

Key Dates

Start Date

December 2, 2025

Primary Completion Date

May 1, 2028

Completion Date

December 1, 2028

Last Updated

December 24, 2025

Enrollment

566

ESTIMATED participants

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

TQB2868 Injection

DRUG

Anlotinib Hydrochloride Capsules

DRUG

Gemcitabine Hydrochloride Injection

DRUG

Paclitaxel for Injection

DRUG

TQB2868 Placebo

DRUG

Contacts

Xianjun Yu, Doctor

CONTACT

13801669875 yxj@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma

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