The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of Borderline Resectable/locally advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Chemotherapy combined with ICIs was started 5-7 days after the completion of radiotherapy: AG: intravenous nab-paclitaxel 125 mg/m2 and gemcitabine 1000mg/m2 d1,8, q3w, 4 cycles. Camrelizumab: 200mg, iv, 30min, q3w, 4 cycles.
Hypofractionated radiotherapy:PGTV=30Gy/5F(PTV≥25Gy/5F),
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGa.R0-resection rate
The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically
Time frame: One week after surgery
Surgical conversion rate
Tumors that were otherwise unresectable were transformed into surgically resectable tumors.
Time frame: 2 to 4 weeks after neoadjuvant therapy
Tumor regression rate
Degree of tumor response to neoadjuvant therapy
Time frame: One week after surgery
Objective response rate (ORR)
It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1).
Time frame: through study completion,an average of 3 year
Disease control rate (DCR)
It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR/SD) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1).
Time frame: through study completion,an average of 3 year
3-year Overall survival (OS)
The time between the start of randomization and death from any cause
Time frame: Three years from enrollment
3-year Event Free Survival (EFS)
The time from randomization until disease progression, treatment discontinuation for any cause, or death.
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Time frame: Three years from enrollment
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of participants with adverse events will be recorded at each treatment visit.
Time frame: From enrollment to the end of treatment at 8 weeks
Quality of life scores
Evaluate the quality of life according to The World Health Organization quality of life (WHOQOL) -BREF. The minimum value is 1, the maximum value is 5. And higher scores mean a better outcome. The number of participants with quality of life will be recorded at each treatment visit.
Time frame: 1 years after therapy