Cascade Therapy: A Concept of Sequential Management of Biological System States — The Therapeutically Primed State (S) as the Basis for a New Treatment Architecture

This manuscript introduces Cascade Therapy — a novel paradigm that shifts focus from developing new therapeutic agents to managing the sequential physiological states of the biological system. The core hypothesis is the Therapeutically Primed State (State S): a transient, controllable, and objectively measurable condition that increases susceptibility to a subsequent intervention. The central conceptual novelty is the proposal that the lungs function as a universal "antigen scanner" — because the pulmonary circulation receives 100% of cardiac output, the pulmonary capillary bed constitutes an unavoidable physiological filter for all circulating tumor cells, regardless of their origin. This reframes the therapeutic challenge from "reaching every lesion" to "intercepting antigenic information along a shared route". As an illustrative model, the "Cascade-LITE" protocol is proposed, combining metabolic preconditioning, inhaled oncolytic virus (MMR vaccine platform), and immune consolidation (BCG + imiquimod). The model is formulated as five independently falsifiable hypotheses, accompanied by a preclinical verification program and a Phase 0/Ia dose-escalation study design. Status and Caveat This work is purely theoretical and does not describe human or animal studies. The proposed framework offers a strictly falsifiable scientific program reducible to five independently testable assumptions. The protocol and Phase 0/Ia study design are conceptual proposals for scientific review, not clinical instructions or medical advice, and must not be used for self-administration. Keywords: cascade therapy; therapeutically primed state; lungs as antigen scanner; oncolytic virus; MMR vaccine; circulating tumor cells; trained immunity; dose-escalation study design.