An Umbrella-designed Prospective Multicenter Randomized Open-label Superiority Trial Evaluating Multi-biomarker-guided Precision Therapy for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
Summary
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.
Timeline
- Start
- 2026-07-07
- Primary completion
- 2029-06-30
- Completion
- 2029-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Black garlic fermentation extract | Unknown | — | — |
| Subject | Indole-3-carbinol | Small molecule | — | — |
| Subject | Lactobacillus rhamnosus | Other / unclassified | — | — |
| Subject | Retlirafusp alfa | Protein / enzyme biologic | — | — |
| Comparator | Cisplatin | Other / unclassified | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
Indications
No indication recorded.