Wuhan Xiehe Hospital Tower

Healthy donors are commonly mobilized with granulocyte colony-stimulating factor (G-CSF) to collect peripheral blood stem cells for allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the efficiency of mobilization varies among donors, and suboptimal mobilization may require additional collection procedures or rescue strategies. This prospective, multicenter, randomized trial evaluates whether the timing of daily G-CSF administration (morning vs evening) affects the level of circulating CD34+ cells in healthy donors. Participants will be randomly assigned to receive subcutaneous G-CSF once daily for 4-5 consecutive days either at 08:00 (±15 minutes) or at 20:00 (±15 minutes). The goal of the study is to identify a practical dosing schedule that may improve stem cell mobilization and streamline donor collection procedures.
The study protocol was substantially amended following approval by the Institutional Review Board. The amendments included revisions to the G-CSF administration regimen, the primary and secondary outcome measures, and the assessment schedule. Enrollment under the revised protocol commenced on 1st Nov. Participants enrolled under the previous protocol version will be documented separately and will not be included in the prespecified primary analysis of the revised-protocol cohort.

This is a prospective, single-arm, biomarker-stratified, multicenter phase 2 clinical trial. All enrolled patients first receive short-course radiotherapy (SCRT), followed by measurement of serum β-hydroxybutyrate (β-HB) levels to calculate the post-radiotherapy elevation rate. Patients are stratified into an β-HB-positive stratum (elevation significantly) and an β-HB-negative stratum (no elevation), then randomized 1:1 within each stratum to receive either perioperative chemotherapy plus PD-1 inhibitor or perioperative chemotherapy alone.
The primary endpoint is the complete response (CR) rate, defined as the composite of pathological complete response (pCR) and clinical complete response (cCR). The study aims to evaluate the efficacy and safety of adding PD-1 inhibitor to perioperative chemotherapy in LARC, and to validate post-radiotherapy β-HB elevation as a predictive biomarker for immunotherapy benefit.