Esophageal CancerESCA-DTNCT07757022
AI-Driven Digital Twin and Drug Simulation for Esophageal Cancer
An observational study of Esophageal Cancer, run by Henan Cancer Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Toripalimab, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- Adequate bone marrow, liver, and renal function, confirmed by the following laboratory tests performed within 7 days prior to enrollment:
- Hemoglobin ≥ 90 g/L;
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- 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.
- 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.
- Expected to achieve R0 resection.
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 1.
- Life expectancy ≥ 3 months.
- 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.
- Patients must voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and agree to follow-up.
Who cannot join
- 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.
- Unstable angina within 3 months or myocardial infarction within 6 months prior to enrollment.
- Psychiatric disorders that may affect study compliance.
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- Known or concurrent hemorrhagic disorders.
- Female patients who are pregnant or breastfeeding.
- Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or other severe pulmonary impairment.
- Autoimmune diseases, immunodeficiency states, or history of organ transplantation.
- Known hypersensitivity to the study drugs (toripalimab, paclitaxel, cisplatin) or their excipients.
- Abnormal coagulation function (PT > 16s, APTT > 53s, TT > 21s, Fib < 1.5 g/L), bleeding tendency, or patients receiving thrombolytic or anticoagulant therapy.
- Bronchial asthma requiring intermittent use of bronchodilators or medical intervention.
- 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.)
- Human immunodeficiency virus (HIV) positivity.
- Any other condition that, in the investigator's judgment, may compromise patient safety, interfere with study compliance, or preclude successful completion of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Song, M.D./Ph.D contact
About this study
Official title: Construction of Artificial Intelligence Model for Esophageal Cancer Digital Twin Patients and Drug Efficacy Simulation Verification Based on Supercomputing Platform and Multi-Omics Data
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.
Read the detailed description
This is a prospective, single-center, observational cohort study integrating virtual clinical trial technology. The study is designed to validate the feasibility and accuracy of AI-driven digital twin models for predicting treatment responses in esophageal cancer patients.
Background and Rationale:
China accounts for approximately half of the global esophageal cancer cases, with the highest incidence rates concentrated in the Taihang Mountain region, particularly Henan Province. Despite advances in early diagnosis and treatment, tumor heterogeneity and individual patient variability continue to limit therapeutic efficacy, especially in advanced-stage patients. Virtual clinical trial technology, which uses supercomputing to simulate drug efficacy and safety across virtual patient populations, offers a promising approach to accelerate drug screening while reducing costs and ethical constraints associated with conventional trials.
Study Population:
The study will enroll 400 patients with locally advanced (T1N1-3M0 or T2-3N0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM staging), aged 18 to 75 years, with ECOG performance status 0-1 and adequate organ function. All patients must have received no prior antitumor therapy for esophageal cancer and be candidates for R0 resection.
Virtual Patient Modeling:
For each enrolled patient, peripheral blood samples will be collected prior to treatment initiation for whole-exome sequencing (WES). Multi-omics data will be integrated with clinical information to generate a personalized digital twin for each participant. These virtual patients will undergo simulated treatment and efficacy prediction using the drug efficacy prediction model.
Treatment Arms:
- Experimental Group (n=200): Neoadjuvant immunochemotherapy consisting of toripalimab (JS001) 240 mg IV on day 3, paclitaxel 175 mg/m2 IV on day 1, and cisplatin 75 mg/m2 IV on day 1, administered in 21-day cycles for 2 cycles, followed by surgery and postoperative toripalimab maintenance therapy (240 mg Q3W for up to 8 cycles or 6 months).
- Control Group (n=200): Neoadjuvant chemotherapy consisting of paclitaxel 175 mg/m2 IV on day 1 and cisplatin 75 mg/m2 IV on day 1, administered in 21-day cycles for 2 cycles, followed by surgery.
Surgery and Follow-up:
Surgery will be performed 4-8 weeks after the last neoadjuvant cycle using McKeown minimally invasive or open esophagectomy with two-field lymphadenectomy. Postoperative surveillance includes contrast-enhanced CT of the chest and upper abdomen and contrast-enhanced CT of the neck, performed every 3 months for 2 years, then every 6 months until year 5. Adverse events will be monitored throughout and graded according to CTCAE v5.0.
Outcomes:
The primary endpoint is Event-Free Survival (EFS), defined as the time from randomization to the first occurrence of inoperability, distant metastasis, local recurrence, or death from any cause, whichever occurs first. Secondary endpoints include pathological complete response (pCR) rate, overall survival (OS), disease-free survival (DFS), objective response rate (ORR), R0 resection rate, major pathological response (MPR) rate, quality of life (EORTC QLQ-C30 and QLQ-OES18), and safety (incidence of adverse events per CTCAE v5.0).
Virtual Clinical Trial Component:
Parallel to the real-world IIT, a virtual clinical trial will be conducted using the AI-powered drug simulation platform. The virtual predictions will be compared with actual clinical outcomes to evaluate the accuracy and reliability of the digital twin model. The study will assess the concordance between predicted and observed responses, including sensitivity, specificity, positive predictive value, and negative predictive value of the model.
Statistical Analysis:
Based on the primary endpoint EFS, a sample size of 400 patients (1:1 allocation) is planned, providing 90% power at a two-sided alpha level of 0.05 to detect a hazard ratio of 0.68, assuming a median EFS of 20 months in the control group. Efficacy analyses will be performed on the intention-to-treat (ITT) population using stratified log-rank tests and Cox proportional hazards models. Kaplan-Meier methods will estimate survival distributions. Safety analyses will be conducted on the safety set.
Study Duration:
The study is anticipated to enroll participants from January 2026 to June 2028, with final data collection completed by December 2028.
- Conditions
- Esophageal Cancer
- Being tested
- Toripalimab, Paclitaxel, Cisplatin
- Keywords
- Esophageal Cancer, Computational Medicine, Multi-Omics, Artificial Intelligence, Virtual Clinical Trials, Digital Twin, Toripalimab
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called JS001
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.
PaclitaxelDrug
Also called PTX
Administered at 175 mg/m2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively.
CisplatinDrug
Also called DDP
Administered at 75 mg/m2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Toripalimab; Drug: Paclitaxel; Drug: Cisplatin | |
| 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. Receives: Drug: Paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization up to 36 months
Secondary outcomes (9)
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.
Measured: At the time of surgery (approximately 4-8 weeks after completion of neoadjuvant therapy)
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.
Measured: From randomization up to 36 months
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.
Measured: From surgery up to 36 months
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.
Measured: Up to 24 months
R0 Resection Rate
R0 resection rate is defined as the proportion of patients achieving microscopically margin-negative resection, confirmed by the absence of tumor cells at the proximal, distal, and circumferential resection margins on pathological examination.
Measured: At the time of surgery (approximately 4-8 weeks after completion of neoadjuvant therapy)
Major Pathological Response (MPR) Rate
Major pathological response (MPR) is defined as the proportion of patients with ≤10% viable tumor cells remaining in the resected primary tumor specimen after neoadjuvant therapy, assessed according to the Ryan tumor regression grade (TRG) criteria.
Measured: At the time of surgery (approximately 4-8 weeks after completion of neoadjuvant therapy)
EORTC QLQ-OES18 Quality of Life Score
Quality of life assessed using the EORTC QLQ-OES18 esophageal cancer-specific module. Scores range from 0 to 100; higher scores indicate worse symptoms. Administered at baseline and at each follow-up visit.
Measured: From randomization up to 36 months
EORTC QLQ-C30 Quality of Life Score
Quality of life assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) version 3.0. Scores range from 0 to 100; higher scores indicate better functioning and quality of life for global health status and functional scales, while higher scores indicate worse symptoms for symptom scales. Administered at baseline and at each follow-up visit.
Measured: From randomization up to 36 months
Incidence of Treatment-Emergent Adverse Events
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: From the signing of informed consent through 30 days after the last dose of study treatment (or 90 days for serious adverse events)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start30 Jul 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, YanZheng,MD, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757022
- Sponsor's protocol ID
- 2025-431
- Acronym
- ESCA-DT
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Artificial Intelligence Model for Esophageal Cancer Digital Twin Patients and Drug Efficacy Simulation Verification Based on Supercomputing Platform and Multi-Omics Data
- ClinicalTrials.gov ID
- NCT07757022
- Acronym / sponsor ID
- ESCA-DT / 2025-431
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Computational Medicine, Multi-Omics, Artificial Intelligence, Virtual Clinical Trials, Digital Twin, Toripalimab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-center, observational cohort study integrating virtual clinical trial technology. The study is designed to validate the feasibility and accuracy of AI-driven digital twin models for predicting treatment responses in esophageal cancer patients.
Background and Rationale:
China accounts for approximately half of the global esophageal cancer cases, with the highest incidence rates concentrated in the Taihang Mountain region, particularly Henan Province. Despite advances in early diagnosis and treatment, tumor heterogeneity and individual patient variability continue to limit therapeutic efficacy, especially in advanced-stage patients. Virtual clinical trial technology, which uses supercomputing to simulate drug efficacy and safety across virtual patient populations, offers a promising approach to accelerate drug screening while reducing costs and ethical constraints associated with conventional trials.
Study Population:
The study will enroll 400 patients with locally advanced (T1N1-3M0 or T2-3N0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM staging), aged 18 to 75 years, with ECOG performance status 0-1 and adequate organ function. All patients must have received no prior antitumor therapy for esophageal cancer and be candidates for R0 resection.
Virtual Patient Modeling:
For each enrolled patient, peripheral blood samples will be collected prior to treatment initiation for whole-exome sequencing (WES). Multi-omics data will be integrated with clinical information to generate a personalized digital twin for each participant. These virtual patients will undergo simulated treatment and efficacy prediction using the drug efficacy prediction model.
Treatment Arms:
- Experimental Group (n=200): Neoadjuvant immunochemotherapy consisting of toripalimab (JS001) 240 mg IV on day 3, paclitaxel 175 mg/m2 IV on day 1, and cisplatin 75 mg/m2 IV on day 1, administered in 21-day cycles for 2 cycles, followed by surgery and postoperative toripalimab maintenance therapy (240 mg Q3W for up to 8 cycles or 6 months).
- Control Group (n=200): Neoadjuvant chemotherapy consisting of paclitaxel 175 mg/m2 IV on day 1 and cisplatin 75 mg/m2 IV on day 1, administered in 21-day cycles for 2 cycles, followed by surgery.
Surgery and Follow-up:
Surgery will be performed 4-8 weeks after the last neoadjuvant cycle using McKeown minimally invasive or open esophagectomy with two-field lymphadenectomy. Postoperative surveillance includes contrast-enhanced CT of the chest and upper abdomen and contrast-enhanced CT of the neck, performed every 3 months for 2 years, then every 6 months until year 5. Adverse events will be monitored throughout and graded according to CTCAE v5.0.
Outcomes:
The primary endpoint is Event-Free Survival (EFS), defined as the time from randomization to the first occurrence of inoperability, distant metastasis, local recurrence, or death from any cause, whichever occurs first. Secondary endpoints include pathological complete response (pCR) rate, overall survival (OS), disease-free survival (DFS), objective response rate (ORR), R0 resection rate, major pathological response (MPR) rate, quality of life (EORTC QLQ-C30 and QLQ-OES18), and safety (incidence of adverse events per CTCAE v5.0).
Virtual Clinical Trial Component:
Parallel to the real-world IIT, a virtual clinical trial will be conducted using the AI-powered drug simulation platform. The virtual predictions will be compared with actual clinical outcomes to evaluate the accuracy and reliability of the digital twin model. The study will assess the concordance between predicted and observed responses, including sensitivity, specificity, positive predictive value, and negative predictive value of the model.
Statistical Analysis:
Based on the primary endpoint EFS, a sample size of 400 patients (1:1 allocation) is planned, providing 90% power at a two-sided alpha level of 0.05 to detect a hazard ratio of 0.68, assuming a median EFS of 20 months in the control group. Efficacy analyses will be performed on the intention-to-treat (ITT) population using stratified log-rank tests and Cox proportional hazards models. Kaplan-Meier methods will estimate survival distributions. Safety analyses will be conducted on the safety set.
Study Duration:
The study is anticipated to enroll participants from January 2026 to June 2028, with final data collection completed by December 2028.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Immunochemotherapy plus Surgery with Postoperative Toripalimab Maintenance | – | Drug: Toripalimab, Drug: Paclitaxel, Drug: CisplatinPatients 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. |
| Neoadjuvant Chemotherapy plus Surgery | – | Drug: Paclitaxel, Drug: CisplatinPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (19 listed)
- 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.
- Adequate bone marrow, liver, and renal function, confirmed by the following laboratory tests performed within 7 days prior to enrollment:
Key exclusion criteria (16 listed)
- 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.
- Unstable angina within 3 months or myocardial infarction within 6 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToripalimabAlso: JS001Recombinant 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. | Drug | Neoadjuvant Immunochemotherapy plus Surgery with Postoperative Toripalimab Maintenance |
| PaclitaxelAlso: PTXAdministered at 175 mg/m2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively. | Drug | Neoadjuvant Chemotherapy plus Surgery, Neoadjuvant Immunochemotherapy plus Surgery with Postoperative Toripalimab Maintenance |
| CisplatinAlso: DDPAdministered at 75 mg/m2 IV on day 1 of each 21-day cycle for 2 cycles preoperatively. | Drug | Neoadjuvant Chemotherapy plus Surgery, Neoadjuvant Immunochemotherapy plus Surgery with Postoperative Toripalimab Maintenance |
Primary outcome
Event-Free Survival (EFS)
Time frame: From randomization up to 36 months
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.
9 secondary outcomes
Pathological Complete Response (pCR) Rate
Time frame: At the time of surgery (approximately 4-8 weeks after completion of neoadjuvant therapy)
Overall Survival (OS)
Time frame: From randomization up to 36 months
Disease-Free Survival (DFS)
Time frame: From surgery up to 36 months
Objective Response Rate (ORR)
Time frame: Up to 24 months
R0 Resection Rate
Time frame: At the time of surgery (approximately 4-8 weeks after completion of neoadjuvant therapy)
Major Pathological Response (MPR) Rate
Time frame: At the time of surgery (approximately 4-8 weeks after completion of neoadjuvant therapy)
EORTC QLQ-OES18 Quality of Life Score
Time frame: From randomization up to 36 months
EORTC QLQ-C30 Quality of Life Score
Time frame: From randomization up to 36 months
Incidence of Treatment-Emergent Adverse Events
Time frame: From the signing of informed consent through 30 days after the last dose of study treatment (or 90 days for serious adverse events)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Song, M.D./Ph.D contact
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Henan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Zheng, M.D./Ph.D ((+86)0371-65587610, hnszlyylixiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: From randomization up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.