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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

Recruiting now Phase 1, PHASE2 Last updated 27 June 2025
What this trial tests

Phase 1, PHASE2 trial testing Regorafenib combined with Toripalimab and Albumin paclitaxel in Pancreatic Cancer Metastatic in 23 participants. Currently enrolling.

Timeline
26 May 2025
Primary endpoint
30 May 2027
30 May 2027

Quick facts

Lead sponsorCancer Hospital Chinese Academy of Medical Science, Shenzhen Center
PhasePhase 1, PHASE2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment23
Start date26 May 2025
Primary completion30 May 2027
Estimated completion30 May 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Pancreatic Cancer Metastatic

Currently open trials in the same condition.

Other Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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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