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

NCT04902261 | Unknown Phase 2

• 1 other identifier: CHEC2020-144
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 1-Year Survival Rates

  The proportion of patients who survive more than 1 year after treatment.

  Up to 2 years

Secondary Outcomes (4)

• Overall Response Rate（ORR)

  Up to 2 years

• Progression Free Survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

• Adverse Events (AEs)

  Up to 2 years

Study Arms (2)

Tislelizumab combined with Nab-paclitaxel and Gemcitabine

EXPERIMENTAL

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

Nab-paclitaxel and Gemcitabine

ACTIVE COMPARATOR

Drug: Nab paclitaxel; Drug: Gemcitabine

Interventions

Tislelizumab DRUG

Tislelizumab 200 mg every three weeks

Tislelizumab combined with Nab-paclitaxel and Gemcitabine

Nab paclitaxel DRUG

Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks

Nab-paclitaxel and Gemcitabine; Tislelizumab combined with Nab-paclitaxel and Gemcitabine

Gemcitabine DRUG

Gemcitabine 1000mg/m2 on d1 and d8 every three weeks

Nab-paclitaxel and Gemcitabine; Tislelizumab combined with Nab-paclitaxel and Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

tislelizumab; Taxes; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gang Jin, Doctor

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiwei Guo, Doctor

CONTACT

+8618621500666; gestwa@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 26, 2021
• Study Start: November 20, 2020
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)