Oncology · Medical Literature
Clinical Efficacy of Modified San'ao Decoction and Erchen Decoction for Esophageal Dysphagia (Shi Bi) with Phlegm-Dampness and Blood Stasis Syndrome.
Abstract
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.
Clinical relevance
In patients with advanced esophageal squamous cell carcinoma (ESCC) presenting with phlegm-dampness/blood-stasis syndrome who have progressed on first-line platinum-based chemotherapy, does the addition of modified San'ao Decoction and Erchen Decoction to camrelizumab plus anlotinib improve tumor response, TCM syndrome scores, serum tumor markers, and peripheral T-cell parameters compared with camrelizumab plus anlotinib alone? __SNAPSHOT__ {"studyDesign":"Randomized, open-label, assessor-blinded controlled trial (protocol description published in JoVE)","setting":"Not reported (Chinese TCM-integrated oncology clinical setting implied; single or multi-center not specified)","sampleSize":"n=96 (control group: camrelizumab + anlotinib; observation group: camrelizumab + anlotinib + modified San'ao and Erchen Decoctions; exact per-arm allocation not reported in abstract)","population":"Adults with advanced ESCC histologically confirmed, presenting with esophageal dysphagia (Shi Bi) attributed to phlegm-dampness and blood-stasis syndrome per TCM differentiation, who had progressed after prior first-line platinum-based chemotherapy","intervention":"Modified San'ao Decoction and Erchen Decoction (standardized herbal preparation per protocol) added to camrelizumab (anti-PD-1) plus anlotinib (multi-target TKI)","comparator":"Camrelizumab plus anlotinib alone (standard second-line immunotherapy/targeted therapy doublet)","primaryOutcome":"Not explicitly designated as a single primary outcome in the abstract; reported endpoints include objective response rate (ORR), disease control rate (DCR) per immune-modified RECIST criteria, TCM syndrome scores, serum tumor markers, and peripheral T-cell subset parameters","followUp":"Three treatment cycles (exact cycle length and calendar duration not reported in abstract)","fundingSource":"Not reported"}
Key findings
After three treatment cycles, the observation group (TCM decoctions added to camrelizumab + anlotinib) demonstrated higher ORR and DCR compared with the control group (camrelizumab + anlotinib alone), assessed by immune-modified RECIST criteria. Greater reductions in TCM syndrome scores and serum tumor marker levels were also observed in the observation group. Peripheral T-cell subset parameters showed more favorable changes in the observation group. Severe adverse events of note included myelosuppression, hepatic impairment, and additional events whose full description was truncated in the provided abstract. CRITICAL NOTE: No absolute or relative effect sizes, confidence intervals, p-values, NNT, or NNH values were reported in the available abstract. All efficacy and safety findings are directional only and cannot be quantitatively evaluated from the provided text.
Practice implications
This study, available only as an abstract/protocol description published in JoVE, evaluated whether integrating TCM herbal therapy with a second-line immunotherapy-targeted therapy doublet could improve outcomes in a TCM-defined subpopulation of ESCC patients. The findings are directional and suggest potential additive benefit of the herbal combination on tumor response, symptom burden (via TCM scoring), tumor biomarkers, and T-cell immunity. However, no quantitative effect sizes, confidence intervals, or p-values were accessible, making it impossible to assess the magnitude or statistical robustness of these findings. The open-label design introduces substantial performance and detection bias for patient-reported and investigator-assessed outcomes, including TCM syndrome scoring. The study population was restricted to patients with TCM-defined phlegm-dampness/blood-stasis syndrome following platinum failure—a highly specific phenotype not routinely classified in Western oncology practice—limiting generalizability to broader ESCC populations. Patients of non-East Asian ancestry, those treated in first-line, or those without TCM syndrome classification were not represented. Whether changes in TCM syndrome scores or serum tumor markers translate to survival benefit (overall survival or progression-free survival) was not established. Practice change is not warranted on the basis of this abstract alone. __LIMITATIONS__ Only an abstract/protocol description is available; full results, statistical analyses, and complete safety data were not accessible for review.,Open-label design with assessor blinding only for tumor response; TCM syndrome scoring and patient-reported outcomes are highly susceptible to performance and reporting bias without blinding of patients and treating clinicians.,No primary outcome was pre-specified with adequate clarity; multiple co-equal endpoints (ORR, DCR, TCM scores, biomarkers, T-cell subsets) increase risk of type I error without appropriate multiplicity correction.,Short follow-up of three treatment cycles with no survival data (overall survival, progression-free survival) reported, precluding assessment of clinically meaningful benefit.,Sample size of 96 patients is modest for a heavily pre-treated advanced solid tumor population; underpowered to detect differences in survival endpoints or rare adverse events.,TCM syndrome classification (phlegm-dampness/blood-stasis) lacks standardized, internationally validated diagnostic criteria, limiting reproducibility and external validity.,Generalizability is restricted to East Asian ESCC patients who meet TCM syndrome criteria and have platinum-refractory disease; findings cannot be extrapolated to Western populations or other ESCC subtypes.,Funding source not reported, precluding assessment of potential conflicts of interest.,The abstract was truncated; the complete adverse event profile, including the full characterization and incidence of severe myelosuppression and hepatic impairment, was not available for evaluation.,Absence of placebo control for the herbal component precludes attribution of observed effects specifically to the TCM decoctions versus natural disease course or expectation bias. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This small, open-label, randomized protocol-description study suggests that adding modified San'ao and Erchen Decoctions to camrelizumab plus anlotinib may improve tumor response rates, TCM-defined symptom scores, and peripheral T-cell parameters in platinum-refractory advanced ESCC patients with phlegm-dampness/blood-stasis syndrome. However, no quantitative efficacy data, survival outcomes, or complete safety profiles were available from the abstract, and methodological limitations—including open-label design, short follow-up, and TCM-specific patient selection—substantially restrict interpretability and generalizability. This study is not sufficient to support practice change and should be considered preliminary, hypothesis-generating evidence requiring confirmation in rigorously designed, adequately powered trials with survival endpoints.