Recurrent Pancreatic Cancer
Conditions
Brief summary
To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer
Detailed description
There is heterogeneity in desmoplasia between different metastatic sites in pancreatic cancer. The tumor quasi-characteristics of patients with metastatic PDAC at presentation were more obvious than those of epithelial characteristics, and the quasi-and epithelial subtypes showed different responses to chemotherapy regimens, and the epithelial phenotype tumor quasi-phenotype was associated with metastasis-free survival. Therefore, different metastases of pancreatic cancer may respond differently to medical treatment. There were different metastases after postoperative recurrence of pancreatic cancer, 25.2% had only liver metastases, 14.7% had only lung metastases, 14.7% had multiple distant metastases, and about more than half of the patients had postoperative recurrence with only distant metastases and no in situ metastasis. Then whether there is a difference in the efficacy of PD1 drug therapy in patients with different metastases needs to be further verified.
Interventions
DRUGTislelizumab
Tislelizumab 200 mg every three weeks
DRUGNab paclitaxel
Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks
DRUGGemcitabine
Gemcitabine 1000mg/m2 on d1 and d8 every three weeks
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with radiologically or histologically confirmed postoperative Recurrent Pancreatic Cancer * Patients with at least one measurable lesion (according to RECIST 1.1 criteria); * Have not received gemcitabine-based regimen after surgery * No systemic treatment after diagnosis of recurrence * ECOG score 0-1 * Expected survival ≥ 3 months; * Liver function is essentially normal: absolute neutrophil count \> 1500/mm ³; platelet count \> 100,000/mm ³; creatinine less than 1.5 times the upper limit of normal or calculated creatinine clearance (CRCI) \> 45 mL/min; total bilirubin ≤ 2.0 mg/dL; aspartate aminotransferase (AST) and alanine aminotransferase less than 2.5 times the upper limit of normal * Appropriate to participate in this trial as assessed by the investigator before entering the study * Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study * Signed Informed Consent Form
Exclusion criteria
* Patients who only undergo abdominal laparotomy but do not undergo resection of pancreatic tumor tissue * Received gemcitabine-based regimen after surgery * Systemic treatment after diagnosis of recurrence * Patients with previous allergic reactions to similar drugs * Pregnant or lactating patients * Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening (including detectable ascites or ascites requiring puncture and aspiration on physical examination at screening) * History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc * Patients with severe cardiovascular diseases within 12 months before enrollment, such as symptomatic coronary heart disease, ≥ grade II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, etc * Presence of any active immunodeficiency or autoimmune disease and/or history of any immunodeficiency or autoimmune disease that may recur at screening (e.g., hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc) * Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment * Patients with other previous malignancies who are not cured * Immunodeficient patients, such as HIV-positive * Uncontrollable psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-Year Survival Rates | Up to 2 years | The proportion of patients who survive more than 1 year after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate（ORR) | Up to 2 years | the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) |
| Progression Free Survival (PFS) | Up to 2 years | The time from the date of treatment to the first of either disease progression, relapse or death |
| Overall survival (OS) | Up to 2 years | The time from the date of treatment start to the date of death or to the date of last follow-up for patients alive |
| Adverse Events (AEs) | Up to 2 years | the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0; Surgical safety including Intraoperative blood loss，PHLF assessed by ISGLS（2012），Postoperative complications evaluated by modified Clavien-Dindo system. |
Countries
China
Contacts
Primary ContactShiwei Guo, Doctor
Outcome results
None listed