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Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer

Primary Purpose

Pancreatic Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Gemcitabine
Nab paclitaxel
Hypofractionated radiotherapy with simultaneous integrated boost
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Carcinoma

Eligibility Criteria

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

Inclusion Criteria: 1. Age >= 18 years; 2. Eastern Cooperative Oncology Group (ECOG) score of 0-1; 2. Pancreatic cancer confirmed by histology or cytology; 3. Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan; 4. Hematological indexes: Neutrophil count >= 1.5 x 10^9/L Hemoglobin >= 10g / dl Platelet count >= 100 x 10^9 / L 5. Biochemical indicators: Total bilirubin <= 1.5 x upper limit of normal value (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 1.5 x ULN; Creatinine clearance rate >= 60ml / min. 6. Participants of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test: 7. Signed informed consent; 8. Follow the protocol and follow-up procedures. Exclusion Criteria: Have received systematic anti-tumor treatment. Previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment). Active bacterial or fungal infection (> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0). Human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group. Autoimmune diseases or immune defects who are treated with immunosuppressive drugs. Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group. Drug abuse, clinical or psychological or social factors make informed consent or research implementation affected. Allergic to programmed cell death protein-1 (PD-1) monoclonal antibody immunotherapy drugs.

Sites / Locations

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Concurrent radiochemotherapy combined with immunotherapy

Arm Description

Participants will receive tislelizumab plus gemcitabine and nab-paclitaxel in cycles of 21 days. Non-progressors will plus concurrent radiotherapy during the 3rd cycle of chemotherapy. After 4-6 cycles treatment, Multiple disciplinary team (MDT) will evaluate whether to undergo radical surgery.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
RECIST Version 1.1

Secondary Outcome Measures

R0 resection rate
R0 resection rate
Median Progression Free Survival (mPFS)
RECIST Version 1.1
Median Overall survival (mOS)
RECIST Version 1.1
Disease control rate (DCR)
RECIST Version 1.1
Pathological grade of tumor tissue after neoadjuvant therapy
Pathological grade of tumor tissue after neoadjuvant therapy
Adverse Events
Adverse event (AE)、Serious adverse event (SAE)

Full Information

First Posted
November 22, 2022
Last Updated
December 1, 2022
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05634564
Brief Title
Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer
Official Title
Efficacy and Safety of Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.
Detailed Description
Due to the hidden onset and rapid progression of pancreatic cancer, most patients are already locally advanced or have distant metastasis at the time of diagnosis and lose the opportunity for surgery. Even among operable patients, about 50% will have recurrence and metastasis one year after surgery. Therefore, more and more evidence supports neoadjuvant therapy for patients with high risk factors for resectable pancreatic cancer, and conversion therapy followed by surgery for patients with borderline resectable and locally advanced pancreatic cancer. Therefore, the objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent radiochemotherapy combined with immunotherapy
Arm Type
Experimental
Arm Description
Participants will receive tislelizumab plus gemcitabine and nab-paclitaxel in cycles of 21 days. Non-progressors will plus concurrent radiotherapy during the 3rd cycle of chemotherapy. After 4-6 cycles treatment, Multiple disciplinary team (MDT) will evaluate whether to undergo radical surgery.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Tislelizumab 200mg administered intravenously on Days 1 of every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Intervention Description
Gemcitabine 125 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated radiotherapy with simultaneous integrated boost
Intervention Description
Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy*10 fractions, Planning target volume (PTV) 3Gy*10 fractions.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
RECIST Version 1.1
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
R0 resection rate
Description
R0 resection rate
Time Frame
Up to 1 years
Title
Median Progression Free Survival (mPFS)
Description
RECIST Version 1.1
Time Frame
Up to 2 years
Title
Median Overall survival (mOS)
Description
RECIST Version 1.1
Time Frame
Up to 2 years
Title
Disease control rate (DCR)
Description
RECIST Version 1.1
Time Frame
Up to 2 years
Title
Pathological grade of tumor tissue after neoadjuvant therapy
Description
Pathological grade of tumor tissue after neoadjuvant therapy
Time Frame
Up to 1 years
Title
Adverse Events
Description
Adverse event (AE)、Serious adverse event (SAE)
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Age >= 18 years; 2. Eastern Cooperative Oncology Group (ECOG) score of 0-1; 2. Pancreatic cancer confirmed by histology or cytology; 3. Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan; 4. Hematological indexes: Neutrophil count >= 1.5 x 10^9/L Hemoglobin >= 10g / dl Platelet count >= 100 x 10^9 / L 5. Biochemical indicators: Total bilirubin <= 1.5 x upper limit of normal value (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 1.5 x ULN; Creatinine clearance rate >= 60ml / min. 6. Participants of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test: 7. Signed informed consent; 8. Follow the protocol and follow-up procedures. Exclusion Criteria: Have received systematic anti-tumor treatment. Previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment). Active bacterial or fungal infection (> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0). Human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group. Autoimmune diseases or immune defects who are treated with immunosuppressive drugs. Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group. Drug abuse, clinical or psychological or social factors make informed consent or research implementation affected. Allergic to programmed cell death protein-1 (PD-1) monoclonal antibody immunotherapy drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Du, MD
Phone
86-25-83106666
Email
dujuanglyy@163.com
Facility Information:
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Du, M.D. Ph.D
Phone
+86-025-83106666
Email
dujunglyy@163.com
First Name & Middle Initial & Last Name & Degree
Juan Du, M.D. Ph.D

12. IPD Sharing Statement

Learn more about this trial

Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer

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