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)

The protocol examines whether thymalfasin adjusted to immune status can support a PRaG-based regimen.

BMJ open · Mar 8, 2024
Original authors: Yuehong Kong, Rongzheng Chen, Meiling Xu, Junjun Zhang, Guangqiang Chen, Zhihui Hong, Hong Zhang, Xiaoxiao Dai, Yifu Ma, Xiangrong Zhao, Yong Peng, Chenyang Zhang, Pengfei Xing, Liyuan Zhang

Study protocol: planned research, not a report of completed treatment outcomes.

Who was studied?

Planned enrollment: up to 60 patients with advanced refractory solid tumors.

What does the publication report?

Prospective, open-label, single-arm, multicenter design; the publication describes planned methods rather than completed efficacy results.

Safety findings

Safety and toxicity are planned assessments; observed event rates are not reported here.

How should we interpret it?

This is a study protocol, not a report of treatment results. Planned enrollment and endpoints are not observed outcomes.

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This independently written summary was checked against the publicly available abstract. It is not a translation of the full paper or a clinical recommendation.

Educational reporting, not individualized medical advice. Discuss treatment decisions with your clinical team.