This is a prospective, multicenter, randomized, open-label, umbrella superiority clinical trial for patients with advanced metastatic esophageal squamous cell carcinoma who have not received prior anti-tumor treatment.
All eligible participants will be randomly assigned into two cohorts: Cohort A (standard treatment group) and Cohort B (biomarker-guided precision treatment group).
Patients in Cohort A will receive first-line standard therapy consisting of TP chemotherapy plus PD-1 inhibitor.
All patients in Cohort B will first complete three biomarker tests, then be divided into 4 sub-groups based on biomarker results to receive biomarker-directed additional treatment combined with the same standard backbone therapy. Participants with all negative biomarkers or failed biomarker testing will receive the identical standard treatment as Cohort A.
The primary objective is to compare the survival benefit between biomarker-guided multi-strategy precision therapy and conventional standard first-line treatment.
Aged between 18 and 75 years (calculated on the date of signing the informed consent form);
Patients with metastatic esophageal squamous cell carcinoma (ESCC) confirmed by histopathology or cytology;
Treatment-naïve patients with no prior anti-tumor therapy;
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, with an expected survival of more than 3 months;
Brain metastases with symptoms or symptom control duration less than 2 months;
History of or concurrent other malignant tumors within the past 3 years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
Absolute Neutrophil Count (ANC) < 1.5 × 10⁹/L;
Platelet count < 100 × 10⁹/L;
Parallel
Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor
DrugPaclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor
Retlirafusp alfa / Indole-3-carbinol + Black garlic fermentation extract / Lactobacillus rhamnosus / Placebo + Paclitaxel + Cisplatin (TP regimen) plus PD-1 inhibitor
DrugGroup B1 (TGF-guided intervention, n=73): Plasma TGF-B ELISA levels positive, combined with Retlirafusp alfa on top of chemo-immunotherapy backbone; Group B2 (metabolite-guided intervention, n=73): Did not meet TGF-β positivity, combined with indole-3-carbinol and black garlic fermentation extract on top of chemo-immunotherapy backbone; Group B3 (Lactobacillus-guided intervention, n=73): Those who don't meet B1 or B2 criteria but have positive blood Lactobacillus qPCR levels, combined with Lactobacillus rhamnosus on top of chemo-immunotherapy backbone; Group B4 (Screening failed group, n=55): All three biomarker tests are negative or testing failed due to technical reasons, receive the same conventional treatment as cohort A
Progression-Free Survival (PFS)
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Survival (OS)
Correlation analysis between TGFβ and Incidence of treatment response
TGFβ concentration is detected by plasma ELISA
Correlation analysis between Metabolite Score and Incidence of treatment response
Metabolite Score is detected by plasma metabolome
Correlation analysis between blood Lactobacillus qPCR levels and Incidence of treatment response
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