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NCT07165951
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)
Phase 3 trial testing TQB2868 Injection in Metastatic Pancreatic Ductal Adenocarcinoma in 566 participants. Currently enrolling.
1 May 2028
Quick facts
| Lead sponsor | Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 566 |
| Start date | 2 December 2025 |
| Primary completion | 1 May 2028 |
| Estimated completion | 1 December 2028 |
| Sites | 71 locations across China |
Drugs / interventions tested
- TQB2868 Injection — full drug profile →
- Anlotinib Hydrochloride Capsules — full drug profile →
- Gemcitabine Hydrochloride Injection — full drug profile →
- Paclitaxel for Injection — full drug profile →
- TQB2868 Placebo
Conditions studied
- Metastatic Pancreatic Ductal Adenocarcinoma — all drugs for Metastatic Pancreatic Ductal Adenocarcinoma →
Sponsor
Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. — full company profile →
Who can join
Adults 18 to 75, any sex, with Metastatic Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Overall Survival
Time frame: 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).
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07165951
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Pancreatic Ductal Adenocarcinoma
Currently open trials in the same condition.
- NCT06904378 — ONT01 and Gemcitabine/Nab-paclitaxel as Second Line Therapy for Metastatic Pancreatic Ductal Adenocarcinoma · Phase 1, PHASE2 · recruiting
- NCT07214298 — Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma · Phase 1, PHASE2 · recruiting
- NCT07089940 — OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma · EARLY_PHASE1 · recruiting
- NCT06989437 — A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Signif · Phase 2, PHASE3 · recruiting
- NCT07096362 — Utility of ctDNA in Early Switch of First-line mFOLFIRINOX in Metastatic Pancreatic Ductal Adenocarcinoma · Phase 2 · recruiting
Other Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. trials
Trials by the same sponsor.
- NCT06760182 — Clinical Trial of TQH2722 Injection in Patients With Seasonal Allergic Rhinitis · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07165951 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.
- Last refreshed: 28 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07165951.
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