A Phase 2 interventional study of SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin in Carcinoma, Pancreatic Ductal, sponsored by Ruijin Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
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.
53 studies on the registry are indexed under Carcinoma, Pancreatic Ductal; 10 are open to participants now.
This study's planned enrollment of 20 is below the median of 65 across 42 interventional studies indexed under Carcinoma, Pancreatic Ductal.
Browse Carcinoma, Pancreatic Ductal studies →Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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Subjects must meet the following criteria for hematology test:
Subjects must meet the following criteria for blood chemistry tests:
Exclusion Criteria:
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; Thymalfasin: 4.8 mg, subcutaneous injection, twice a week, on Day 1 and Day 4 of each week during Weeks 1 \~ 13; Albumin-bound paclitaxel: 125 mg/m2, i.v., on Day 1 and Day 8 of each treatment cycle; Gemcitabine: 1000mg/m2, i.v., on Day 1 and Day 8 of each treatment cycle; After 4 cycles of preoperative neoadjuvant therapy, radical surgery will be evaluated by the MDT team within 2-4 weeks after completion of chemotherapy + immunotherapy.
R0 resection rate
Defined as the proportion of patients in the ITT population who undergo R0 resection following neoadjuvant therapy among patients undergoing surgery.
Time frame: within 10 days after surgery
Tumor regression grade (TRG)
Tumor regression grade was determined according to the postoperative pathological results.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 months
Major pathologic response (MPR) rate
Defined as the proportion of patients in the ITT population who achieve TRG1 among patients undergoing surgery.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (before surgery)
TRAE
Incidence of treatment-related adverse event
Time frame: from commencing of treatment to the 30th day after surgery
irAE
Incidence of immune-related adverse event
Time frame: 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
Time frame: within 30 days after surgery
The expression of CD68
The density, H-score of each marker in paraffin-embedded tissue sections detected by mIHC
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 3 months after surgery
No study locations are listed for this record.
Plan to share: No — Export of individual patient data is a sensitive issue according to current Chinese laws.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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