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/Phase 2
Conditions studied: Pancreatic Cancer Metastatic
In brief
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.
Key facts
- Study ID
- NCT07040228
- Run by
- Junjie Hang
- People needed
- 23
- Starts
- 2025-05-26
- Expected to finish
- 2027-05-30
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);
- Age ≥ 18 years old and ≤ 80 years old;
- Patients with unresectable/metastatic pancreatic cancer confirmed by histopathology;
- Imaging confirmation of tumor progression after previous first-line and second-line standard treatment;
- According to RECIST 1.1 criteria, patients must have at least one measurable target lesion;
- Eastern Cancer Collaboration Group (ECOG) Physical Fitness Status Score: 0-2 points;
- Expected survival time ≥ 2 months;
- Absolute neutrophil count (ANC) ≥ 1.5 × 10 \^ 9/L, platelets ≥ 100 × 10 \^ 9/L, and hemoglobin ≥ 90 g/L (No blood transfusion or blood products within 14 days prior to laboratory examination.
- Not treated with granulocyte colony-stimulating factor or other hematopoietic stimulating factors);
- Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal values (≤ 5 times the upper limit of normal values for patients with liver metastases); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver metastasis);
- Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result must be negative, And willing to use appropriate contraception methods during the trial period and 6 months after the last administration of the trial drug.
You may not qualify if…
- Have hypersensitivity reactions to any research drug or its components;
- Concurrent serious uncontrolled infections or other serious uncontrolled accompanying diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);
- Heart function and disease meet one of the following conditions:
- Long QTc syndrome or QTc interval>480 ms;
- Complete left bundle branch block, grade II or III atrioventricular block;
- Severe and uncontrolled arrhythmias requiring medication treatment;
- New York College of Cardiology classification ≥ III;
- Heart ejection fraction (LVEF) below 50%;
- History of myocardial infarction, unstable angina, and severe unstable ventricular arrhythmia within 6 months prior to recruitment or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or there may be electrocardiographic evidence of acute ischemic or active conduction system abnormalities.
- Active infection of hepatitis B and C (hepatitis B virus surface antigen is positive and hepatitis B virus DNA exceeds 1x103 copies/mL; Hepatitis C virus RNA exceeding 1x103 copies/mL).Asymptomatic chronic carriers of hepatitis B or hepatitis C excluded;
- Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- Imaging confirms intestinal obstruction;
- Previously or currently suffering from other malignant tumors simultaneously (Except for non melanoma basal cell carcinoma and breast/cervical carcinoma in situ that have been effectively controlled and other malignant tumors that have been effectively controlled without treatment in the past five years);
- Pregnant and lactating women, as well as reproductive age patients who are unwilling to take contraceptive measures;
- Patients who require treatment for merging with other malignant tumors;
- History of pulmonary hemorrhage/hemoptysis ≥ grade 2 (defined as at least 2.5mL of bright red blood) within one month prior to the first administration;
- Within 6 months prior to the first administration, there are arterial embolism, severe bleeding (excluding bleeding caused by surgery), and a tendency for severe bleeding;
- Merge symptomatic brain metastases, meningeal metastases, spinal cord tumor invasion, and spinal cord compression syndrome;
- Have used other clinical trial drugs within one month before the first administration;
- The researchers have determined that patients who are not suitable to participate in this study.
Where it is running
- Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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