BridgeMD
New treatment option for Pancreatic Cancer Metastatic
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
ClinicalTrials.gov ID: NCT07040228
What this study is testing
What is Regorafenib combined with Toripalimab and Albumin paclitaxel?
Regorafenib combined with Toripalimab and Albumin paclitaxel is an investigational medicine, being studied as a potential treatment for pancreatic cancer metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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;
You likely can't join 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...
- 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;
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.