AI-Driven Digital Twin and Drug Simulation for Esophageal Cancer

Sponsor
Henan Cancer Hospital
Study ID
NCT07757022
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Toripalimab — DRUG
    Recombinant humanized anti-PD-1 monoclonal antibody administered at 240 mg IV on day 3 of each 21-day cycle for 2 cycles preoperatively, followed by 240 mg IV Q3W postoperatively for up to 8 cycles.
  • Paclitaxel — DRUG
    Administered at 175 mg/m2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively.
  • Cisplatin — DRUG
    Administered at 75 mg/m2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively.

Study Details

This study aims to integrate multi-omics data (genomics, transcriptomics, proteomics) from esophageal cancer patients with artificial intelligence and digital twin technology to construct personalized virtual patient models that precisely simulate individual responses to targeted therapies. Through a drug simulation platform, this study will rapidly screen potential effective drug combinations and optimize dosage and treatment regimens. The project attempts to replace portions of traditional clinical trials with virtual clinical trial technology, substantially shortening the R\&D cycle, reducing costs, and effectively addressing the complexity of individualized treatment. Specifically, this study will conduct a head-to-head virtual clinical trial parallel to a real-world investigator-initiated trial (IIT) in patients with locally advanced esophageal squamous cell carcinoma, comparing the efficacy predictions from the virtual model with actual clinical outcomes. The ultimate goal is to explore the application of large-scale AI models in esophageal cancer targeted therapy, provide personalized treatment recommendations, and advance the implementation of precision medicine in esophageal cancer.

Key Dates

First listed
Aug 11, 2026
Start date
Jul 30, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Neoadjuvant Immunochemotherapy plus Surgery with Postoperative Toripalimab Maintenance
    Patients in this group receive neoadjuvant immunochemotherapy consisting of toripalimab (JS001) 240 mg intravenously on day 3, paclitaxel 175 mg/m² intravenously on day 1, and cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days for 2 cycles. Approximately 4-8 weeks after completion of neoadjuvant therapy, patients undergo McKeown minimally invasive or open esophagectomy with two-field lymphadenectomy. Following surgery (within 3 weeks ± 3 days, no later than 2.5 months postoperatively), patients receive postoperative toripalimab maintenance therapy at 240 mg intravenously every 3 weeks for up to 8 cycles (approximately 6 months) or until disease progression, unacceptable toxicity, or withdrawal of consent.
  • Arm: Neoadjuvant Chemotherapy plus Surgery
    Patients in this group receive neoadjuvant chemotherapy consisting of paclitaxel 175 mg/m² intravenously on day 1 and cisplatin 75 mg/m² intravenously on day 1, repeated every 21 days for 2 cycles. Approximately 4-8 weeks after completion of neoadjuvant therapy, patients undergo McKeown minimally invasive or open esophagectomy with two-field lymphadenectomy. No postoperative maintenance therapy is administered. Patients are followed up according to the same schedule as the experimental group.

Primary Outcome Measure

Event-Free Survival (EFS) [ Time Frame: From randomization up to 36 months ]

Central Contacts

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