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| Name | Class |
|---|---|
| Qilu Pharmaceutical Group Co., Ltd | UNKNOWN |
| Shanghai Junshi Biomedical Technology Co., Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research Scheme Experimental Group | Experimental | Three line treatment of advanced pancreatic cancer with regofinil combined with teripril monoclonal antibody and albumin paclitaxel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib combined with Toripalimab and Albumin paclitaxel | Drug | Regorafenib combined with Toripalimab and Albumin paclitaxel as the third line treatment for patients with advanced pancreatic cancer |
| Measure | Description | Time Frame |
|---|---|---|
| (PFS) | Progression-Free Survival | Dated from the first treatment with study medication to the first documented PD or death owing to any cause, whichever occurred first,assessed up to 60 months. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | up to 60 months |
| OS | Overall Survival | Dated from the date of first treatment with study medication to the date of death owing to any cause or censored on the date of last follow-up,assessed up to 60 months. |
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Inclusion 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 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.
Exclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hang Junjie, doctorate | Contact | 86+13681709736 | katerhjj0000@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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