Virtual patients could revolutionize cancer drug testing
NCT ID NCT07757022
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This trial is testing whether artificial intelligence can create 'digital twin' models of esophageal cancer patients to predict how they will respond to a combination of immunotherapy and chemotherapy. The study will compare the AI's predictions against real outcomes in patients receiving the treatment. The goal is to see if virtual clinical trials can help personalize treatment and speed up drug development.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of toripalimab (an immunotherapy drug), paclitaxel (chemotherapy), and cisplatin (chemotherapy), given before and after surgery.
- What this could lead to
- If successful, this could pave the way for using AI digital twins to predict which drug combinations work best for individual esophageal cancer patients, potentially speeding up treatment discovery and personalizing care.
- What could go wrong
- This is an early-stage approach, and the AI predictions may not match real-world outcomes. The trial is also limited to a specific type of esophageal cancer, so results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. 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. 3. No prior antitumor therapy for esophageal cancer (including chemotherapy, radiotherapy, or immunotherapy). 4. Preoperative evaluation of organ function indicates no surgical contraindications. 5. Adequate bone marrow, liver, and renal function, confirmed by the following laboratory tests performed within 7 days prior to enrollment: * Hemoglobin ≥ 90 g/L; * White blood cell count ≥ 4.0 × 10\^9/L; * Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; * Platelet count ≥ 100 × 10\^9/L; * Total bilirubin ≤ 1.5 × upper limit of normal (ULN); * ALT and AST ≤ 2.5 × ULN; * International normalized ratio (INR) of prothrombin time ≤ 1.5 × ULN, with activated partial thromboplastin time (APTT) within normal range; * Serum creatinine ≤ 1.5 × ULN. 6. No prior chemotherapy, radiotherapy, or hormone therapy for malignant tumors; no history of other malignancies, except for prostate cancer patients who received hormone therapy and have achieved disease-free survival (DFS) \> 5 years. 7. Expected to achieve R0 resection. 8. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 1. 9. Life expectancy ≥ 3 months. 10. Women of childbearing potential must agree to use effective contraceptive measures (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion. Serum or urine pregnancy test must be negative within 7 days prior to enrollment, and patients must not be breastfeeding. Male patients must agree to use contraceptive measures during the study and for 6 months after study completion. 11. Patients must voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and agree to follow-up. Exclusion Criteria: 1. Patients not meeting the inclusion criteria. 2. Presence of multiple primary malignancies (synchronous or metachronous). 3. Active infections requiring systemic treatment. 4. Requirement for continuous systemic corticosteroid therapy (\>10 mg/day prednisone or equivalent) for comorbid conditions. 5. Unstable angina within 3 months or myocardial infarction within 6 months prior to enrollment. 6. Psychiatric disorders that may affect study compliance. 7. Known or concurrent hemorrhagic disorders. 8. Female patients who are pregnant or breastfeeding. 9. Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or other severe pulmonary impairment. 10. Autoimmune diseases, immunodeficiency states, or history of organ transplantation. 11. Known hypersensitivity to the study drugs (toripalimab, paclitaxel, cisplatin) or their excipients. 12. Abnormal coagulation function (PT \> 16s, APTT \> 53s, TT \> 21s, Fib \< 1.5 g/L), bleeding tendency, or patients receiving thrombolytic or anticoagulant therapy. 13. Bronchial asthma requiring intermittent use of bronchodilators or medical intervention. 14. Active hepatitis B (HBV) or hepatitis C (HCV) infection. (Patients who are HBsAg positive or HBcAb positive may be eligible if HBV DNA is below the lower limit of detection/quantification; patients who are HCV antibody positive may be eligible if HCV RNA is below the lower limit of detection/quantification.) 15. Human immunodeficiency virus (HIV) positivity. 16. Any other condition that, in the investigator's judgment, may compromise patient safety, interfere with study compliance, or preclude successful completion of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can a new drug shrink tumors that resist standard care?