AG Combined With Immunotherapy And SBRT In Patients With Potentially Resectable Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Carcinoma

DRUG: Toripalimab
DRUG: Gemcitabine
DRUG: Nab paclitaxel
OTHER: SBRT

PRAG

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 2023-07-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-10-06
First Submitted that Met QC Criteria 2023-10-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-10-12
First Posted (ACTUAL) 2023-10-12	Results First Posted N/A	Last Verified 2023-07

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:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Concurrent radiochemotherapy combined with immunotherapy 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 evalu	DRUG: Toripalimab Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks DRUG: Gemcitabine Gemcitabine 1000 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks DRUG: Nab paclitaxel Nab paclitaxel 125 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks. OTHER: SBRT SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy10 fractions, Planning target volume (PTV) 3Gy10 fractions

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Concurrent radiochemotherapy combined with immunotherapy

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 evalu

DRUG: Toripalimab

Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks

DRUG: Gemcitabine

Gemcitabine 1000 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks

DRUG: Nab paclitaxel

Nab paclitaxel 125 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks.

OTHER: SBRT

SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy*10 fractions, Planning target volume (PTV) 3Gy*10 fractions

Primary Outcome Measures	Measure Description	Time Frame
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	2 years
R0 resection rate	R0 resection rate	2 years

Secondary Outcome Measures	Measure Description	Time Frame
os	OS is defined as the time from randomization to death due to any cause.	3 years
pfs	PFS is defined as the time from the first day of randomization to the date of first record of disease progression or death.	3 years
dcr	DCR including CR, PR, and SD	3 years
Adverse Events	Adverse event (AE)、Serious adverse event (SAE)	3 years

Contacts and Locations

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

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:

Collaborators and Investigators

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

The First Affiliated Hospital with Nanjing Medical University
Fudan University
Shanghai Changzheng Hospital
The First Affiliated Hospital of Soochow University
Xuzhou Central Hospital

Investigators

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

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.

Learn

Resources

Patients

Caregivers

Clinical Trial Record