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

Last updated: August 31, 2023
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Treatment

Gemcitabine

Tislelizumab

Nab paclitaxel

Clinical Study ID

NCT04902261
CHEC2020-144
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with radiologically or histologically confirmed postoperative RecurrentPancreatic 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; plateletcount > 100,000/mm ³; creatinine less than 1.5 times the upper limit of normal orcalculated creatinine clearance (CRCI) > 45 mL/min; total bilirubin ≤ 2.0 mg/dL;aspartate aminotransferase (AST) and alanine aminotransferase less than 2.5 times theupper limit of normal
  • Appropriate to participate in this trial as assessed by the investigator beforeentering the study
  • Male and female subjects of childbearing potential must agree to use an effectivemethod of contraception throughout the study
  • Signed Informed Consent Form

Exclusion

Exclusion Criteria:

  • Patients who only undergo abdominal laparotomy but do not undergo resection ofpancreatic 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 clinicallysignificant ascites at screening (including detectable ascites or ascites requiringpuncture 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, suchas 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 anyimmunodeficiency 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 toenrollment
  • Patients with other previous malignancies who are not cured
  • Immunodeficient patients, such as HIV-positive
  • Uncontrollable psychosis

Study Design

Total Participants: 140
Treatment Group(s): 3
Primary Treatment: Gemcitabine
Phase: 2
Study Start date:
November 20, 2020
Estimated Completion Date:
November 20, 2023

Study 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.

Connect with a study center

  • Changhai Hospital

    Shanghai, 200433
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.