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The aim of this study is to explore the efficacy and safety of a new combination regimen of GnP regimen, SBRT and the anti-PD-1/VEGF bis-antibody, Ivonescimab, in patients with recurrent metastatic advanced pancreatic cancer. The efficacy predictive biomarkers of this combination regimen will be further explored through information such as spatial analysis of the tumor immune microenvironment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnP + Ivonescimab +SBRT | Experimental | Only one cohort of patients will be included, specifically those with pathologically confirmed metastatic pancreatic cancer and, who have not received any prior systemic anti-tumor therapy (including chemotherapy, radiation, or other investigational treatments) or those who have had prior radical pancreatic surgery for pancreatic cancer and have received regular postoperative adjuvant chemotherapy and have developed recurrence or metastasis more than 6 months after the last adjuvant chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnP in combination with Ivonescimab and SBRT | Combination Product | Gemcitabine 1000mg/m2, ivgtt,vdays 1 and 8, nab-Paclitaxel 125mg/m2, ivgtt, days 1 and 8 in combination with Ivonescimab 20mg/kg d1, every 21 days. Cycle 2 will be synchronized with primary or metastatic SBRT. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month-PFS rate | Proportion of patients with progression-free survival at 6 months. | Follow up with patients for up to 24 months |
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Inclusion Criteria:
Patients with pathologically confirmed metastatic pancreatic cancer;
Patients who have not received any prior systemic anti-tumor therapy, or who have undergone prior radical pancreatic cancer surgery and received regular postoperative adjuvant chemotherapy, and who have developed recurrence or metastasis more than 6 months after final adjuvant chemotherapy;
Aged 18 to 75 years old;
Eastern Cooperative Oncology Group performance status score (ECOG) ≤ 2;
According to imaging and surgical evaluation, the liver lesion is unresectable or rhe patient is unable to tolerate surgery, and the primary lesion has no serious complications (perforation, obstruction or hemorrhea that cannot be managed by medical therapy);
At least one measurable tumor lesion: length and diameter of spiral CT greater than or equal to 10 mm, lymph node short diameter greater than or equal to 15 mm; maximum diameter of conventional CT or physical examination greater than or equal to 20mm;
Adequate organ functions as follows:
Absolute neutrophil count ≥1500/mm3, leukocyte≥4000/mm3, platelet count ≥80,000/mm3, hemoglobin ≥9.0 g/dL; total bilirubin≤2.0 × upper limit of normal (UNL); serum creatinine ≤1.5 × UNL; alanine aminotransferase, aspartate aminotransferase ≤5 × UNL;
Life expectancy of longer than 3 months;
No history of autoimmune disease and no current co-morbid autoimmune disease;
Participate the study voluntarily and sign the informed consent document.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |