RecruitingPhase 1Phase 2NCT07040228

A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer


Sponsor

Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

Enrollment

23 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining regorafenib (a targeted cancer drug), toripalimab (an immunotherapy), and albumin-bound paclitaxel (a chemotherapy) works as a third-line treatment for patients with advanced pancreatic cancer that has progressed after two prior treatments. **You may be eligible if...** - You are between 18 and 80 years old - You have unresectable or metastatic pancreatic cancer confirmed by biopsy - Your cancer has progressed after first-line and second-line standard treatments - Tumor progression has been confirmed by imaging **You may NOT be eligible if...** - You have not yet tried two prior lines of treatment - You have serious liver, kidney, or heart conditions - You have active autoimmune conditions or cannot tolerate immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRegorafenib combined with Toripalimab and Albumin paclitaxel

Regorafenib combined with Toripalimab and Albumin paclitaxel as the third line treatment for patients with advanced pancreatic cancer


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07040228


Related Trials