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)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 566 (estimated)
• Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-02
• Primary completion: 2028-05-01
• Completion: 2028-12-01
• First posted: 2025-09-10
• Last updated: 2025-12-24

Locations

70 sites across 1 country: China