Actively Recruiting
A Phase Ib/II Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for Third-line Treatment of Advanced Pancreatic Cancer
Led by Junjie Hang · Updated on 2026-05-18
23
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Junjie Hang
Lead Sponsor
Q
Qilu Pharmaceutical Group Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining Regorafenib with Toripalimab and Albumin-bound Paclitaxel as a third-line treatment for patients with unresectable or metastatic pancreatic cancer. This trial aims to determine the best dose of Regorafenib and assess how well this combination works and its safety in this patient group. The study has two phases: Phase Ib focuses on finding the maximum tolerated dose of Regorafenib with fixed doses of Toripalimab and Paclitaxel-albumin, given in cycles every three weeks. Phase II uses the recommended dose from Phase Ib to further evaluate efficacy and safety. Treatments are given until the cancer progresses or side effects become intolerable. Participants will undergo regular assessments including tumor imaging to measure progression-free survival, objective response rate, and overall survival up to 60 months. Safety and tolerability will be closely monitored. The total participation duration depends on treatment response and tolerability. The trial includes adults aged 18 to 80 with confirmed advanced pancreatic cancer who have progressed after standard treatments.
CONDITIONS
Brief Title
A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years
- Confirmed unresectable or metastatic pancreatic cancer by histopathology
- Tumor progression after previous first-line and second-line treatments confirmed by imaging
- At least one measurable target lesion per RECIST 1.1 criteria
- ECOG physical fitness status score between 0 and 2
- Expected survival time of 2 months or more
- Adequate blood cell counts without recent blood transfusions or stimulating factor treatments
- Liver and kidney function within defined normal limits
- Negative pregnancy test within 7 days before enrollment for women of childbearing age and willingness to use contraception during and 6 months after treatment
You will not qualify if you...
- Allergy to any study drug or its components
- Serious uncontrolled infections or other severe uncontrolled diseases including moderate or severe kidney injury
- Heart conditions such as long QTc syndrome, certain arrhythmias, low ejection fraction, recent heart attacks or unstable angina
- Active hepatitis B or C infection with elevated viral loads
- HIV infection
- Intestinal obstruction confirmed by imaging
- Other active malignant tumors except certain controlled cancers
- Pregnancy, lactation, or unwillingness to use contraception
- Need for treatment of other malignant tumors
- Recent severe pulmonary bleeding or bleeding tendencies within 6 months
- Symptomatic brain metastases or spinal cord involvement
- Use of other clinical trial drugs within one month before starting treatment
- Any condition deemed unsuitable for participation by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months or until disease progression or discontinuation
Participants receive Regorafenib combined with Toripalimab and Albumin-bound Paclitaxel as the third-line treatment for advanced pancreatic cancer.
Visits occur according to treatment cycles as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
H
Hang Junjie, doctorate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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