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AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer

Primary Purpose

Pancreatic Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Gemcitabine
Nab paclitaxel
SBRT
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: Age >= 18 years; Eastern Cooperative Oncology Group (ECOG) score of 0-1; Pancreatic cancer confirmed by histology or cytology; Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan; Hematological indexes: Neutrophil count >= 1.5 x 10^9/L Hemoglobin >= 10g / dl Platelet count >= 100 x 10^9/L; 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. 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; Signed informed consent; 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 School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Concurrent radiochemotherapy combined with immunotherapy

Arm Description

Participants will receive toripalimab 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

ORR
RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1
R0 resection rate
R0 resection rate

Secondary Outcome Measures

os
OS is defined as the time from randomization to death due to any cause.
pfs
PFS is defined as the time from the first day of randomization to the date of first record of disease progression or death.
dcr
DCR including CR, PR, and SD
Adverse Events
Adverse event (AE)、Serious adverse event (SAE)

Full Information

First Posted
July 31, 2023
Last Updated
October 6, 2023
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
The First Affiliated Hospital with Nanjing Medical University, Fudan University, Shanghai Changzheng Hospital, The First Affiliated Hospital of Soochow University, Xuzhou Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06080854
Brief Title
AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer
Official Title
Efficacy and Safety of AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 10, 2023 (Anticipated)
Primary Completion Date
June 6, 2025 (Anticipated)
Study Completion Date
June 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators
The First Affiliated Hospital with Nanjing Medical University, Fudan University, Shanghai Changzheng Hospital, The First Affiliated Hospital of Soochow University, Xuzhou Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
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
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent radiochemotherapy combined with immunotherapy
Arm Type
Experimental
Arm Description
Participants will receive toripalimab 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)
Toripalimab
Intervention Description
Toripalimab 240mg 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
Nab paclitaxel 125 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks.
Intervention Type
Other
Intervention Name(s)
SBRT
Intervention Description
SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy*10 fractions, Planning target volume (PTV) 3Gy*10 fractions
Primary Outcome Measure Information:
Title
ORR
Description
RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1
Time Frame
2 years
Title
R0 resection rate
Description
R0 resection rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
os
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
3 years
Title
pfs
Description
PFS is defined as the time from the first day of randomization to the date of first record of disease progression or death.
Time Frame
3 years
Title
dcr
Description
DCR including CR, PR, and SD
Time Frame
3 years
Title
Adverse Events
Description
Adverse event (AE)、Serious adverse event (SAE)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years; Eastern Cooperative Oncology Group (ECOG) score of 0-1; Pancreatic cancer confirmed by histology or cytology; Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan; Hematological indexes: Neutrophil count >= 1.5 x 10^9/L Hemoglobin >= 10g / dl Platelet count >= 100 x 10^9/L; 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. 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; Signed informed consent; 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.
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

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36889321
Citation
Du J, Lu C, Mao L, Zhu Y, Kong W, Shen S, Tang M, Bao S, Cheng H, Li G, Chen J, Li Q, He J, Li A, Qiu X, Gu Q, Chen D, Qi C, Song Y, Qian X, Wang L, Qiu Y, Liu B. PD-1 blockade plus chemoradiotherapy as preoperative therapy for patients with BRPC/LAPC: A biomolecular exploratory, phase II trial. Cell Rep Med. 2023 Mar 21;4(3):100972. doi: 10.1016/j.xcrm.2023.100972. Epub 2023 Mar 7.
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AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer

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