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TQB2868

Phase 3

Metastatic Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: May 29, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment566
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07165951Clinical Trial Comparing TQB2868 Injection Combined With Anlotinib Hydrochloride Capsules With Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)PHASE3 RECRUITING 566 — — Dec 2, 2025Dec 1, 2028May 29, 202671 China
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Study Endpoints
Primary Endpoints
Overall Survival
The duration is approximately 2 years

By evaluating overall survival (OS), this study aims to demonstrate the efficacy of TQB2868 injection combined with anlotinib hydrochloride capsules in chemotherapy compared to placebo combined with chemotherapy in the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).

Secondary Endpoints
Progression-Free Survival evaluated by researchers
The duration is approximately 1 year
Objective Response Rate evaluated by researchers
The duration is approximately 1 year
The Disease Control Rate evaluated by the researchers
The duration is approximately 1 year
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TQB2868 Injection+Anlotinib Hydrochloride Capsules+chemotherapyEXPERIMENTALTQB2868 Injection+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection
TQB2868 Placebo+Anlotinib Hydrochloride Capsules+chemotherapyPLACEBO_COMPARATORTQB2868 Placebo+Anlotinib Hydrochloride Capsules+Gemcitabine Hydrochloride Injection+Paclitaxel for Injection
Interventions
NameTypeDescription
TQB2868 InjectionDRUGTQB2868 injection: PD-L1 and Transforming Growth Factor-beta (TGF - β) dual antibody
Anlotinib Hydrochloride CapsulesDRUGAnlotinib Hydrochloride Capsules
Gemcitabine Hydrochloride InjectionDRUGGemcitabine Hydrochloride Injection
Paclitaxel for InjectionDRUGPaclitaxel for Injection
TQB2868 PlaceboDRUGTQB2868 Placebo without drug substance
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites71

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. Acco...

Countries:China
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