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NCT07165951

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)

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

566 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-02

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Pancreatic Ductal Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapy

TQB2868 Injection+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection

Group Type EXPERIMENTAL

TQB2868 Injection

Intervention Type DRUG

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

Anlotinib Hydrochloride Capsules

Intervention Type DRUG

Anlotinib Hydrochloride Capsules

Gemcitabine Hydrochloride Injection

Intervention Type DRUG

Gemcitabine Hydrochloride Injection

Paclitaxel for Injection

Intervention Type DRUG

Paclitaxel for Injection

TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapy

TQB2868 Placebo+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection

Group Type PLACEBO_COMPARATOR

Anlotinib Hydrochloride Capsules

Intervention Type DRUG

Anlotinib Hydrochloride Capsules

Gemcitabine Hydrochloride Injection

Intervention Type DRUG

Gemcitabine Hydrochloride Injection

Paclitaxel for Injection

Intervention Type DRUG

Paclitaxel for Injection

TQB2868 Placebo

Intervention Type DRUG

TQB2868 Placebo without drug substance

Interventions

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TQB2868 Injection

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

Intervention Type DRUG

Anlotinib Hydrochloride Capsules

Intervention Type DRUG

Gemcitabine Hydrochloride Injection

Intervention Type DRUG

Paclitaxel for Injection

Intervention Type DRUG

TQB2868 Placebo

TQB2868 Placebo without drug substance

Intervention Type DRUG

Eligibility Criteria

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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;
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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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