Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer

Naval Military Medical University

Status and phase: Enrolling; Phase 2

Conditions: Recurrent Pancreatic Cancer

Treatments: Drug: Tislelizumab; Drug: Gemcitabine; Drug: Nab paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT04902261

CHEC2020-144

Details and patient eligibility

About

To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Tislelizumab combined with Nab-paclitaxel and Gemcitabine

Experimental group

Treatment:

Drug: Tislelizumab

Drug: Gemcitabine

Drug: Nab paclitaxel

Nab-paclitaxel and Gemcitabine

Active Comparator group

Treatment:

Drug: Gemcitabine

Drug: Nab paclitaxel