NCT05185531 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Li M, Yue J, Zhang B, Shi X, Cui K, Liu J, Li Z, Zhao L
Interim report of Notable-HCC: a phase ?b study of neoadjuvant PD-1 with stereotactic body radiotherapy in patients with resectable HCC[J]. Annals of Oncology. VOLUME 34, SUPPLEMENT 2, S598-S599, OCTOBER 2023
Zhang B, Yue J, Shi X, Cui K, Li L, Zhang C, Sun P, Zhong J, Li Z, Zhao L
Protocol of notable-HCC: a phase Ib study of neoadjuvant tislelizumab with stereotactic body radiotherapy in patients with resectable hepatocellular carcinoma. BMJ Open. 2022 Sep 17;12(9):e060955. doi: 10.1136/bmjopen-2022-060955.

A Phase Ib Study of Neoadjuvant Tislelizumab With Stereotactic Body Radiotherapy in Patients With Resectable Hepatocellular Carcinoma

Clinical trial NCT05185531 - References