AI-Driven Digital Twin and Drug Simulation for Esophageal Cancer
ConditionEsophageal Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Treatment-naïve patients with clinical stage locally advanced (T1N1-3M0 or T2-3N0-3M0) thoracic esophageal squamous cell carcinoma, according to the 8th UICC-TNM staging system.
Cervical color Doppler ultrasound shows no suspicious metastatic lymph nodes, or patients with suspected lymph node metastasis on ultrasound who are eligible for three-field lymphadenectomy.
No prior antitumor therapy for esophageal cancer (including chemotherapy, radiotherapy, or immunotherapy).
Preoperative evaluation of organ function indicates no surgical contraindications.
Disqualifiers
Patients not meeting the inclusion criteria.
Presence of multiple primary malignancies (synchronous or metachronous).
Active infections requiring systemic treatment.
Requirement for continuous systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) for comorbid conditions.
Trial population
The study population consists of patients with locally advanced thoracic esophageal squamous cell carcinoma, clinical stage T1N1-3M0 or T2-3N0-3M0 (8th UICC-TNM staging), aged 18 to 75 years, with ECOG performance status 0-1, no prior antitumor therapy for esophageal cancer, expected to achieve R0 resection, and adequate bone marrow, liver, and renal function meeting the inclusion criteria. Eligible patients will be consecutively enrolled at Henan Cancer Hospital.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Toripalimab
DrugRecombinant 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
DrugAdministered at 175 mg/m2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively.
Cisplatin
DrugAdministered at 75 mg/m2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Neoadjuvant Immunochemotherapy plus Surgery with Postoperative Toripalimab Maintenance3 interventions
Group B: Neoadjuvant Chemotherapy plus Surgery2 interventions
Trial outcomes
Primary outcomes
1
Event-Free Survival (EFS)
Event-Free Survival (EFS) is defined as the time from randomization to the first occurrence of any of the following events: inoperability due to any cause, distant metastasis, local recurrence, or death from any cause, whichever occurs first. Distant metastasis is confirmed by: (1) pathological confirmation of squamous cell carcinoma metastasis in other organs, soft tissues, or skin; (2) PET-CT revealing non-local recurrent hypermetabolic soft tissue lesions; or (3) CT, MRI, or abdominal ultrasound diagnosis of distant metastasis.
Time frame
From randomization up to 36 monthsSecondary outcomes
1
Pathological Complete Response (pCR) Rate
Pathological complete response (pCR) is defined as the absence of viable tumor cells in the primary tumor and all resected lymph nodes (ypT0 ypN0) after neoadjuvant therapy, assessed according to the Ryan tumor regression grade (TRG) criteria.
Time frame
At the time of surgery (approximately 4-8 weeks after completion of neoadjuvant therapy)2
Overall Survival (OS)
Overall Survival (OS) is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date of last known contact.
Time frame
From randomization up to 36 months3
Disease-Free Survival (DFS)
Disease-Free Survival (DFS) is defined as the time from curative-intent surgery to the first occurrence of disease recurrence (local or distant) or death from any cause, whichever occurs first.
Time frame
From surgery up to 36 months4
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients achieving either a complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Time frame
Up to 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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