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

Primary Purpose

Recurrent Pancreatic Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tislelizumab

Nab paclitaxel

Gemcitabine

About this trial

This is an interventional treatment trial for Recurrent Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tislelizumab combined with Nab-paclitaxel and Gemcitabine

Nab-paclitaxel and Gemcitabine

Arm Description

Outcomes

Primary Outcome Measures

1-Year Survival Rates

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

Secondary Outcome Measures

Overall Response Rate（ORR)

the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR)

Progression Free Survival (PFS)

The time from the date of treatment to the first of either disease progression, relapse or death

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

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.

Full Information

NCT ID

NCT04902261

First Posted

May 20, 2021

Last Updated

August 31, 2023

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04902261

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 20, 2020 (Actual)

Primary Completion Date

November 20, 2023 (Anticipated)

Study Completion Date

November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tislelizumab combined with Nab-paclitaxel and Gemcitabine

Arm Type

Experimental

Arm Title

Nab-paclitaxel and Gemcitabine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tislelizumab

Intervention Description

Tislelizumab 200 mg every three weeks

Intervention Type

Drug

Intervention Name(s)

Nab paclitaxel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

1-Year Survival Rates

Description

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

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Overall Response Rate（ORR)

Description

the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR)

Time Frame

Up to 2 years

Title

Progression Free Survival (PFS)

Description

The time from the date of treatment to the first of either disease progression, relapse or death

Time Frame

Up to 2 years

Title

Overall survival (OS)

Description

The time from the date of treatment start to the date of death or to the date of last follow-up for patients alive

Time Frame

Up to 2 years

Title

Adverse Events (AEs)

Description

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shiwei Guo, Doctor

Phone

+8618621500666

gestwa@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Jin, Doctor

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhai Hospital

City

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shiwei Guo, Doctor

Phone

+8618621500666

gestwa@163.com

First Name & Middle Initial & Last Name & Degree

Gang Jin, Doctor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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