Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor And Thymalfasin For BRPC

Study Overview

Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC

This is a prospective, single-center, single-arm, phase II clinical study. The primary purpose of the study was to evaluate the efficacy and safety of radiotherapy with sequential albumin-bound paclitaxel + Gemcitabine chemotherapy + anti-PD-1 monoclonal antibody and Thymalfasin for borderline resectable pancreatic cancer, and to explore clinical indicators related to efficacy, further guiding subsequent individualized precise treatment.

This is a prospective, single-center, single-arm, phase II clinical study. In this study, 20 patients with borderline resectable pancreatic cancer and without any prior treatment will be enrolled. After signing the informed consent form, patients will be screened to ensure they meet the eligibility criteria.Before surgery, eligible patients will receive 4 cycles of neoadjuvant therapy: Tislelizumab combined with AG regimen and SBRT and 13 weeks of Thymalfasin therapy; after 4 cycles, the efficacy will be evaluated and radical surgery will be performed on schedule. The postoperative treatment of patients will be jointly decided by clinical physicians and patients according to the actual conditions of clinical diagnosis and treatment. The main observation indicator is the R0 resection rate after neoadjuvant therapy; Safety assessment: The safety will be assessed after each cycle of neoadjuvant therapy and at 30 days after the last dose; Event follow-up: The events will be followed once every 3 months during the first year after surgery, and once every 6 months during the second year after surgery.

Carcinoma, Pancreatic Ductal

COMBINATION_PRODUCT: SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin

ZDX+PD-1+CRT-PDAC

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 2024-08-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-08-26
First Submitted that Met QC Criteria 2024-08-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-08-27
First Posted (ACTUAL) 2024-08-27	Results First Posted N/A	Last Verified 2024-08

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:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CRT+PD-1 inhibitor+Thymalfasin All eligible 20 subjects will receive a neoadjuvant therapy regimen of chemoradiotherapy combined with anti-PD-1 monoclonal antibody and Thymalfasin.	COMBINATION_PRODUCT: SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin Stereotactic body radiation therapy (SBRT): 30 ~ 40 Gy/5f, Week 1, Day 1 ~ Day 5, 6-8 Gy/time, once a day; 3 weeks as a cycle, for 4 cycles Tislelizumab: 200 mg, i.v., single infusion, 21 days as a cycle for 4 cycles, on Day 1 of each treatment cycle; Thy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CRT+PD-1 inhibitor+Thymalfasin

All eligible 20 subjects will receive a neoadjuvant therapy regimen of chemoradiotherapy combined with anti-PD-1 monoclonal antibody and Thymalfasin.

COMBINATION_PRODUCT: SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin

Stereotactic body radiation therapy (SBRT): 30 ~ 40 Gy/5f, Week 1, Day 1 ~ Day 5, 6-8 Gy/time, once a day; 3 weeks as a cycle, for 4 cycles Tislelizumab: 200 mg, i.v., single infusion, 21 days as a cycle for 4 cycles, on Day 1 of each treatment cycle; Thy

Primary Outcome Measures	Measure Description	Time Frame
R0 resection rate	Defined as the proportion of patients in the ITT population who undergo R0 resection following neoadjuvant therapy among patients undergoing surgery.	within 10 days after surgery

Secondary Outcome Measures	Measure Description	Time Frame
Tumor regression grade (TRG)	Tumor regression grade was determined according to the postoperative pathological results.	within 10 days after surgery
Pathologic complete response (pCR) rate	Defined as the proportion of patients in the ITT population who reach pT0N0M0 among patients undergoing surgery.	within 10 days after surgery
Median progression-free survival (mPFS)	The median time from the first dose to any documented tumor progression or death due to any cause (whichever occurs first) in the ITT population. Patients who are alive at the time of analysis and have no documented disease progression will be reviewed on the date of the last imaging assessment.	24 months
Median overall survival (mOS)	The median time from the first dose to death due to any cause in the ITT population. Patients who are alive at the time of analysis will be reviewed on their last contact date.	24 months
Major pathologic response (MPR) rate	Defined as the proportion of patients in the ITT population who achieve TRG1 among patients undergoing surgery.	within 10 days after surgery
Objective response rate (ORR)	Defined as the proportion of patients in the ITT population achieving complete response (CR) + partial response (PR) according to iRECIST.	Baseline (before surgery)
Disease control rate (DCR)	Defined as the proportion of subjects in the ITT population who achieve disease response and stable disease among all subjects.	Baseline (before surgery)
TRAE	Incidence of treatment-related adverse event	from commencing of treatment to the 30th day after surgery
irAE	Incidence of immune-related adverse event	from commencing of PD-1 inhibitor to the 30th day after surgery
Incidence of surgical complications	Incidence of surgical complications within 30 days after surgery	within 30 days after surgery

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: Jiabin Jin, PhD

Phone Number: +86 18101870031

Email: jjb11501@rjh.com.cn

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.

Investigators

PRINCIPAL_INVESTIGATOR: Baiyong Shen, PhD,MD, Ruijin 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

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Clinical Trial Record