Clinical trial NCT04902261: Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer
Official title: Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Pancreatic Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-Year Survival Rates
timeFrame: Up to 2 years
Secondary outcomes:
measure: Overall Response Rate（ORR)
timeFrame: Up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: Up to 2 years
measure: Overall survival (OS)
timeFrame: Up to 2 years
measure: Adverse Events (AEs)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Gang Jin, Doctor
role: PRINCIPAL_INVESTIGATOR
References: