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NCT07040228
A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer
Phase 1, PHASE2 trial testing Regorafenib combined with Toripalimab and Albumin paclitaxel in Pancreatic Cancer Metastatic in 23 participants. Currently enrolling.
30 May 2027
Quick facts
| Lead sponsor | Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 26 May 2025 |
| Primary completion | 30 May 2027 |
| Estimated completion | 30 May 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Regorafenib combined with Toripalimab and Albumin paclitaxel — full drug profile →
Conditions studied
- Pancreatic Cancer Metastatic — all drugs for Pancreatic Cancer Metastatic →
Sponsor
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Who can join
Adults 18 to 80, any sex, with Pancreatic Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this clinical trial is to explore the efficacy and safety of Regorafenib combined with Toripalimab and Paclitaxel-albumin in patients as the third line treatment for patients with unresectable or metastatic pancreatic cancer.The main question it aims to answer is: Phase Ib: Evaluate the maximum tolerated dose (MTD) of regorafenib and/or phase II clinical recommendations Dose (RP2D). Phase II: Evaluation of the efficacy and safety of Regorafenib Combined with Terriptylimab and Albumin Paclitaxel for Late Third Line Treatment for pancreatic cancer patients. Participants will: Phase Ib: Selected patients will receive treatment with Regorafenib at main dose levels of 40, 80, and 120mg/d (po d1-14 Q3W), Toripalimab(240mg, ivgtt, d1, Q3W), and Paclitaxel-albumi(125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs. Phase II: Regorafenib: Based on the results of the completed Phase I study, determine the dosage for Phase II (po d1-14 Q3W). Toripalimab (240mg, ivgtt, d1, Q3W) and Paclitaxel-albumi (125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07040228
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center trials
Trials by the same sponsor.
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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 NCT07040228 (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 Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
- Last refreshed: 27 June 2025
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/NCT07040228.
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