Tislelizumab Combined With Nab-paclitaxel And Gemcitabine For Recurrent Pancreatic Cancer

Study Overview

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

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

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.

Recurrent Pancreatic Cancer

DRUG: Tislelizumab
DRUG: Nab paclitaxel
DRUG: Gemcitabine

CHEC2020-144

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-05-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-08-31
First Submitted that Met QC Criteria 2021-05-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-09-01
First Posted (ACTUAL) 2021-05-26	Results First Posted N/A	Last Verified 2023-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Tislelizumab combined with Nab-paclitaxel and Gemcitabine	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
ACTIVE_COMPARATOR: Nab-paclitaxel and Gemcitabine	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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Tislelizumab combined with Nab-paclitaxel and Gemcitabine

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

ACTIVE_COMPARATOR: Nab-paclitaxel and Gemcitabine

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

Primary Outcome Measures	Measure Description	Time Frame
1-Year Survival Rates	The proportion of patients who survive more than 1 year after treatment.	Up to 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Overall Response Rate（ORR)	the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR)	Up to 2 years
Progression Free Survival (PFS)	The time from the date of treatment to the first of either disease progression, relapse or death	Up to 2 years
Overall survival (OS)	The time from the date of treatment start to the date of death or to the date of last follow-up for patients alive	Up to 2 years
Adverse Events (AEs)	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.	Up to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shiwei Guo, Doctor

Phone Number: +8618621500666

Email: gestwa@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Gang Jin, Doctor, Changhai Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record