Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC (NCT06573398) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC
20 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years, with ECOG score of 0 \~ 1;
✓. Histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of pancreas;
✓. Classification as borderline resectable pancreatic cancer according to the NCCN Guidelines (2024 Edition);
✓. Deemed suitable for neoadjuvant therapy following discussion by the MDT team of the study site;
✓. Subjects must meet the following criteria for hematology test:
✓. Neutrophil count ≥ 1.5 × 10\^9/L
✓. Hemoglobin ≥ 10 g/dL
✓. Platelet count ≥ 100 × 10\^9/L
Exclusion criteria
✕. Prior systemic anti-tumor therapy;
✕. Prior medical history of other tumors, except for cervical carcinoma in situ, treated squamous cell carcinoma or urothelial bladder carcinoma (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years prior to enrollment);
✕. Prior history of abdominal radiotherapy;
✕. Subjects with active bacterial or fungal infection (≥ Grade 2 as per NCI-CTC, Version 3).
✕. Subjects with HIV, HCV, or HBV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases judged by the investigator to be ineligible for enrollment;