Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study).

"our reporting of the results will strictly follow the guidelines outlined in the consolidated standards of reporting trials statement 10 1136/bmjopen-2023-075642 supp1 supplementary data 10 1136/bmjopen-2023-075642 supp2 supplementary data we thank liwen bianji (edanz) ( www liwenbianji cn ) for editing and drafting the english text of this manuscript."

"Competing interests: None declared."

"Funding: This study was supported by Suzhou Medical Center (Szlcyxzx202103), the National Natural Science Foundation of China (82171828), the Key R&D plan of Jiangsu Province (Social Development, BE2021652), Suzhou Radiotherapy Clinical Medical Center (Szlcyxzx202103), Open project of the State Key Laboratory of Radiology and Radiation Protection of Soochow University (GZK1202014,GZK1202238), Open Project of Provincial Key Laboratory of Soochow University (KJS1961), the Subject construction support project of the Second Affiliated Hospital of Soochow University (XKTJ-RC202001, XKTJHRC20210011), the Suzhou Science and Technology Development Plan (SYS2020143,SKY2022163), Chinese Society of Clinical Oncology Research Foundation of Beijing (Y-XD202002/ZB-0015, Y-pierrefabre202102-0113), Wu Jieping Medical Foundation (320.6750.2021-01-12), The special project of “Technological Innovation” project of CNNC Medical Industry Co. Ltd (ZHYLTD2021001), Suzhou Science and Education Health Project (KJXW2021018), Postgraduate Research & Practice Innovation Program of Jiangsu Province (SJCX22_1508，KYCX22_3223),Youth Employee Pre Research Fund Project of the Second Affiliated Hospital of Soochow University (SDFEYQN1701), Key Medical Discipline Construction Unit of Jiangsu Province for the 14th Five-year plan (JSDW202236)."

"Trial registration number NCT05790447."