Clinical Efficacy of Modified San'ao Decoction and Erchen Decoction for Esophageal Dysphagia (Shi Bi) with Phlegm-Dampness and Blood Stasis Syndrome.

This protocol describes a randomized, open-label, assessor-blinded clinical workflow for evaluating modified San'ao Decoction and Erchen Decoction combined with camrelizumab and anlotinib in patients with advanced esophageal squamous cell carcinoma presenting with esophageal dysphagia and phlegm-dampness/blood-stasis syndrome. Ninety-six patients who had progressed after prior first-line platinum-based chemotherapy were assigned to a control group receiving camrelizumab plus anlotinib or an observation group receiving the same regimen with modified San'ao and Erchen Decoctions. The protocol included standardized patient screening, allocation concealment, decoction preparation, treatment administration, tumor response assessment using immune-modified RECIST criteria, TCM syndrome scoring, serum tumor marker detection, flow cytometric analysis of T-cell subsets, adverse event monitoring, and statistical analysis. After three treatment cycles, the observation group showed higher ORR and DCR, greater reductions in TCM syndrome scores and serum tumor markers, and more favorable changes in peripheral T-cell parameters than the control group. Severe myelosuppression, hepatic impairment, and nausea/vomiting were less frequent in the observation group. These findings suggest that the integrated regimen may be feasible and clinically promising, but the single-center open-label design and short follow-up period limit causal interpretation. Larger multicenter trials with placebo control and longer survival follow-up are needed.