Actively Recruiting
A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer
Led by Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center · Updated on 2025-06-27
23
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Lead Sponsor
Q
Qilu Pharmaceutical Group Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Patient understands the study, agrees to participate, and signs informed consent
- Age 18 to 80 years old
- Unresectable or metastatic pancreatic cancer confirmed by histopathology
- Tumor progression confirmed by imaging after previous first and second-line standard treatments
- At least one measurable target lesion per RECIST 1.1 criteria
- Eastern Cancer Collaboration Group (ECOG) performance status score 0 to 2
- Expected survival time of at least 2 months
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L without recent transfusion or hematopoietic stimulating factors
- Liver and kidney function within specified limits (creatinine ≤ 1.5 times upper limit, AST/ALT ≤ 2.5 times upper limit or ≤ 5 times if liver metastases, total bilirubin ≤ 1.5 times upper limit or ≤ 3 times if liver metastases)
- Women of childbearing age must have a negative pregnancy test within 7 days prior to enrollment and agree to use contraception during the trial and for 6 months after last dose
You will not qualify if you...
- Allergy or hypersensitivity to study drugs or components
- Serious uncontrolled infections or other serious uncontrolled diseases including moderate or severe kidney injury
- Heart conditions including long QTc syndrome, certain arrhythmias, advanced heart failure (NYHA class III or higher), low ejection fraction (<50%), recent myocardial infarction or unstable angina
- Active hepatitis B or C infection with specified viral loads
- HIV infection
- Intestinal obstruction confirmed by imaging
- Other malignant tumors currently or within past 5 years (except certain controlled skin or carcinoma in situ cancers)
- Pregnant, breastfeeding, or unwilling to use contraception if of reproductive age
- Need for treatment of other malignant tumors during study
- History of significant pulmonary hemorrhage within 1 month prior to first dose
- Recent arterial embolism, severe bleeding, or bleeding tendency within 6 months
- Symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, or spinal cord compression
- Use of other clinical trial drugs within 1 month prior to first dose
- Investigator judgment of unsuitability for study participation
AI-Screening
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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
CONTACT
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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