Last reviewed · How we verify
NCT06359275
A Phase II Study on the Safety and Efficacy of PD-1 Combined With Nab-paclitaxel/Gemcitabine and PULSAR in the Treatment of Locally Advanced Unresectable Pancreatic Cancer and Local Recurrence After Surgery.
Phase 2 trial testing PD-1 in Pancreatic Cancer in 81 participants. Currently enrolling.
1 December 2025
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 81 |
| Start date | 1 June 2024 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 October 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- PD-1 — full drug profile →
- Nab-paclitaxel (nab-paclitaxel) — full drug profile →
- Gemcitabine (gemcitabine) — full drug profile →
- PULSAR
Conditions studied
- Pancreatic Cancer — all drugs for Pancreatic Cancer →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Pancreatic Cancer. 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.
-
Progression-free survival (PFS)
Time frame: up to approximately 1 years
PFS is defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
Sponsor's own description
This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pancreatic Cancer: Pathogenesis and Clinical Studies.
Zhou K, Liu Y, Tang C, Zhu H. · · 2025 · cited 6× · PMID 40182139 · DOI 10.1002/mco2.70162 -
The Evolving Role of Neoadjuvant Radiation Therapy in Pancreatic Adenocarcinoma.
Bryant JM, Nakashima J, Khatri VM, Sinnamon AJ, et al · · 2024 · cited 3× · PMID 39597944 · DOI 10.3390/jcm13226800 -
Threading the Needle: Navigating Novel Immunotherapeutics in Pancreatic Ductal Adenocarcinoma.
Demir T, Moloney C, Mahalingam D. · · 2025 · cited 1× · PMID 40075563 · DOI 10.3390/cancers17050715
Verify or expand the search:
- PubMed search for NCT06359275
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PD-1
Trials testing the same drug.
- NCT07214142 — Total Neoadjuvant Therapy With PD-1 for Locally Advcancer Rectal Cancer · Phase 2 · not yet recruiting
- NCT07154316 — Phase II RCT of LCRT vs SCRT + CAPOX/PD-1i/COX-2i in MSS Locally Advanced Rectal Cancer · Phase 2 · recruiting
- NCT06999252 — Rimegepant Combined With PD-1 in Liver Metastasis Colorectal Cancer Patients · Phase 2 · not yet recruiting
- NCT06301386 — Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients · Phase 2 · not yet recruiting
- NCT06322095 — A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors · Phase 2 · unknown
Other recruiting trials for Pancreatic Cancer
Currently open trials in the same condition.
- NCT07126158 — Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma · Phase 2 · recruiting
- NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
- NCT07439757 — AI-Powered Precision Decision-Making for Pancreatic Diseases · recruiting
- NCT07409272 — A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherap · Phase 3 · recruiting
- NCT07236177 — B-GLUCANCER2 : A Pilot Study Evaluating a New Method for Cancer Detection by Measuring the Activity of Different Glycosi · EARLY_PHASE1 · recruiting
Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting
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 NCT06359275 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 23 June 2024
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/NCT06359275.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing