Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer
Study Details
Study Description
Brief Summary
To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Tislelizumab combined with Nab-paclitaxel and Gemcitabine
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Drug: Tislelizumab
Tislelizumab 200 mg every three weeks
Drug: Nab paclitaxel
Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks
Drug: Gemcitabine
Gemcitabine 1000mg/m2 on d1 and d8 every three weeks
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Active Comparator: Nab-paclitaxel and Gemcitabine
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Drug: Nab paclitaxel
Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks
Drug: Gemcitabine
Gemcitabine 1000mg/m2 on d1 and d8 every three weeks
|
Outcome Measures
Primary Outcome Measures
- 1-Year Survival Rates [Up to 2 years]
The proportion of patients who survive more than 1 year after treatment.
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with radiologically or histologically confirmed postoperative Recurrent Pancreatic Cancer
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Patients with at least one measurable lesion (according to RECIST 1.1 criteria);
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Have not received gemcitabine-based regimen after surgery
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No systemic treatment after diagnosis of recurrence
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ECOG score 0-1
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Expected survival ≥ 3 months;
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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
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Appropriate to participate in this trial as assessed by the investigator before entering the study
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Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study
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Signed Informed Consent Form
Exclusion Criteria:
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Patients who only undergo abdominal laparotomy but do not undergo resection of pancreatic tumor tissue
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Received gemcitabine-based regimen after surgery
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Systemic treatment after diagnosis of recurrence
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Patients with previous allergic reactions to similar drugs
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Pregnant or lactating patients
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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)
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History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
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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
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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)
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Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment
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Patients with other previous malignancies who are not cured
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Immunodeficient patients, such as HIV-positive
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Uncontrollable psychosis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Changhai Hospital | Shanghai | China | 200433 |
Sponsors and Collaborators
- Changhai Hospital
Investigators
- Principal Investigator: Gang Jin, Doctor, Changhai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHEC2020-144