Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC
NCT Number: NCT06573398
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Carcinoma, Pancreatic Ductal
Interventions: COMBINATION_PRODUCT: SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01

Summary:
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.

Primary Outcome Measures: 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: 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
Other Outcome Measures: The expression of CD68, The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC, up to 3 months after surgery|The expression of CD86, The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC, up to 3 months after surgery|The expression of CD163, The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC, up to 3 months after surgery|The expression of CD4, The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC, up to 3 months after surgery|The expression of CD8, The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC, up to 3 months after surgery