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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)

NCT07165951 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2025-12-24

No results posted yet for this 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.

Conditions

Interventions

DRUG

TQB2868 Injection

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

DRUG

Anlotinib Hydrochloride Capsules

Anlotinib Hydrochloride Capsules

DRUG

Gemcitabine Hydrochloride Injection

Gemcitabine Hydrochloride Injection

DRUG

Paclitaxel for Injection

Paclitaxel for Injection

DRUG

TQB2868 Placebo

TQB2868 Placebo without drug substance

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-02
Primary Completion
2028-05-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07165951 on ClinicalTrials.gov