NCT06051851: RCT-PAAG

Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer

Recruiting now Phase 2 Last updated 25 September 2023

What this trial tests

Phase 2 trial testing Penpulimab in Pancreatic Adenocarcinoma Metastatic in 177 participants. Currently enrolling.

Timeline

1 July 2023

Primary endpoint
1 July 2025

1 July 2026

Quick facts

Lead sponsor	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	177
Start date	1 July 2023
Primary completion	1 July 2025
Estimated completion	1 July 2026
Sites	1 location across China

Drugs / interventions tested

• Penpulimab (PENPULIMAB) — full drug profile →
• Anlotinib — full drug profile →
• Nab paclitaxel
• Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

• Pancreatic Adenocarcinoma Metastatic — all drugs for Pancreatic Adenocarcinoma Metastatic →

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Who can join

18 and older, any sex, with Pancreatic Adenocarcinoma Metastatic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi-center, open-label， randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Penpulimab combined with Anlotinib and Nab-paclitaxel plus Gemcitabine (PAAG ) versus AG first-line treatment in patients with metastatic pancreatic cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current and Emerging Treatment Options for Pancreatic Cancer: A Comprehensive Review.
   Hayat U, Croce PS, Saadeh A, Desai K, et al · · 2025 · cited 17× · PMID 40004658 · DOI 10.3390/jcm14041129
2. Pancreatic Cancer: Pathogenesis and Clinical Studies.
   Zhou K, Liu Y, Tang C, Zhu H. · · 2025 · cited 6× · PMID 40182139 · DOI 10.1002/mco2.70162
3. Advancing Immunotherapy in Pancreatic Cancer.
   Hegazi A, Rager LE, Watkins DE, Su KH. · · 2024 · cited 5× · PMID 39519112 · DOI 10.3390/ijms252111560
4. Advances in the Management of Pancreatic Cancer: Current Strategies and Emerging Therapies.
   Peshin S, Takrori E, Kodali NA, Bashir F, et al · · 2025 · cited 4× · PMID 40806185 · DOI 10.3390/ijms26157055
5. Systemic Therapy for Metastatic Pancreatic Cancer-Current Landscape and Future Directions.
   Netto D, Frizziero M, Foy V, McNamara MG, et al · · 2024 · cited 2× · PMID 39330013 · DOI 10.3390/curroncol31090385
6. Inflammation, Immunosuppression, and Immunotherapy in Pancreatic Cancer-Where Are We Now?
   Fudalej M, Krupa K, Badowska-Kozakiewicz A, Deptała A. · · 2025 · cited 1× · PMID 40361411 · DOI 10.3390/cancers17091484
7. Case Report: Pseudoprogression of pancreatic acinar cell carcinoma after PD-1 blockade integrated treatment.
   Bai X, Yang D, Chen J, Liu Y, et al · · 2025 · PMID 41409298 · DOI 10.3389/fimmu.2025.1663514
8. Efficacy and safety of TAS-102 plus Surufatinib in third and later line metastatic pancreatic cancer: a prospective, single center and biomarker exploratory, phase II study.
   Lu Y, Lin Q, Mo Y, Liu F, et al · · 2025 · PMID 41039600 · DOI 10.1186/s12943-025-02437-0