Esophageal Squamous Cell CarcinomapCR-ESCCNCT07181850
Predicting Pathological Complete Response in Esophageal Squamous Cell Carcinoma Using a Multimodal Model Integrating Clinical, Radiomics, and Deep Learning Features
An observational study of Esophageal Squamous Cell Carcinoma and Pathological Complete Response, run by Nanjing Medical University at 1 site in China.
Trial summary
This multicenter, retrospective cohort study reviews the medical records and CT scans of adults with esophageal squamous cell carcinoma (ESCC) who received neoadjuvant immunotherapy plus chemotherapy before surgery at three hospitals in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Pathological Complete Response
- What is being tested?
- Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT)
- How many people
- 363 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with biopsy-confirmed ESCC treated at three participating centers in China. Patients received standard neoadjuvant chemo-immunotherapy (e.g., camrelizumab with paclitaxel and cisplatin or carboplatin), had pre-treatment venous-phase chest CT within 14 days, and underwent R0 resection 6-8 weeks post-therapy. pCR status was determined from surgical pathology. Sites include: The Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University; Nanjing Medical University Affiliated Cancer Hospital \& Jiangsu Cancer Hospital \& Jiangsu Institute of Cancer Research; and Nanjing Drum Tower Hospital.
Who may be able to join
- Biopsy-confirmed esophageal squamous cell carcinoma (ESCC). Locally advanced disease per AJCC 8th ed. (cT1N1-T3N0-3M0) on contrast-enhanced CT.
- Completed standardized neoadjuvant chemo-immunotherapy (e.g., paclitaxel + cisplatin/carboplatin with camrelizumab every 2-3 weeks) prior to surgery.
- High-quality venous-phase chest CT (slice thickness ≤5 mm) obtained within 14 days before therapy start.
- Underwent R0 resection 6-8 weeks after therapy. Availability of a definitive postoperative pathology report to ascertain pCR status.
Who cannot join
- Non-squamous histology; distant metastasis (M1); synchronous malignancies. Inadequate imaging quality (no venous phase, slice thickness >5 mm, severe artifacts, or incomplete tumor visualization).
- Did not complete the full treatment course or had missing endpoints (e.g., no pathological response record or lost to follow-up).
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University
Huai'an, Jiangsu, 223000
About this study
Official title: Integration of Clinical, Radiomics, and 2.5D Deep Learning-Based Multiple Instance Learning Features for Predicting Pathological Complete Response in Esophageal Squamous Cell Carcinoma Following Neoadjuvant Immunotherapy and Chemotherapy: A Multicenter Comparative Study
This multicenter, retrospective cohort study reviews the medical records and CT scans of adults with esophageal squamous cell carcinoma (ESCC) who received neoadjuvant immunotherapy plus chemotherapy before surgery at three hospitals in China. The goal is to develop and validate a computer-assisted model that predicts which patients achieve a pathological complete response (pCR)-meaning no residual tumor is found at surgery-after preoperative treatment. Accurate pCR prediction may help clinicians personalize care and avoid unnecessary treatments in likely non-responders.
The study includes 363 patients. For each patient, routinely collected clinical information and preoperative venous-phase chest CT images were analyzed. From CT images, both radiomics features and features learned by a "2.5D" deep learning approach with multiple-instance learning (MIL) were extracted. These were combined with clinical variables to create a multimodal prediction model. Model performance will be evaluated using standard metrics and validated in internal and external cohorts.
Read more
Patients typically received two cycles of taxane-platinum chemotherapy (paclitaxel with cisplatin or carboplatin) combined with camrelizumab every 2-3 weeks before surgery; CT scans were performed within 14 days prior to starting therapy. Surgery (R0 resection) was performed 6-8 weeks after treatment, and pCR was determined by the postoperative pathology report.
This is an observational study; no treatments are assigned by protocol. The study was approved by the Ethics Committee of Nanjing Medical University, with informed consent waived due to the retrospective design.
Read the detailed description
Design and Setting. Multicenter, retrospective cohort study conducted at three affiliated hospitals in China. A total of 363 consecutive ESCC patients met eligibility criteria and were split into a training cohort (n=107), internal validation cohort (n=45), and two external test cohorts (n=129 and n=82).
Population. Inclusion criteria: biopsy-confirmed ESCC; locally advanced disease by AJCC 8th edition (cT1N1-T3N0-3M0) on contrast-enhanced CT; completion of standardized neoadjuvant chemo-immunotherapy; availability of high-quality venous-phase chest CT (slice thickness ≤5 mm) within 14 days before therapy; R0 resection 6-8 weeks post-treatment; and a definitive postoperative pathology report documenting pCR. Key exclusions: non-squamous histology, distant metastasis, synchronous malignancies, poor/no venous-phase imaging, slice thickness >5 mm, severe artifacts, incomplete tumor visualization, incomplete treatment, or missing endpoints.
Neoadjuvant Regimen and Imaging. Patients generally received two cycles of taxane-platinum chemotherapy (paclitaxel plus cisplatin or carboplatin) combined with camrelizumab every 2-3 weeks prior to surgery. CT imaging was standardized to venous-phase contrast with 1-5 mm slices; scans without venous phase or >5 mm thickness were excluded. Tumor volumes were delineated by two radiologists; disagreements were adjudicated by a senior radiologist, and features were harmonized via resampling and intensity normalization.
Feature Extraction and Modeling. The pipeline integrated: (1) clinical variables; (2) conventional CT radiomics features (shape, first-order, GLCM, GLRLM, GLSZM, etc.); and (3) 2.5D deep learning slice embeddings aggregated to the patient level using multiple-instance learning (MIL). The 2.5D approach uses adjacent slices in axial/sagittal/coronal planes with ResNet backbones; attention-based MIL plus histogram/BoW-TF-IDF descriptors summarized slice-level predictions. Feature selection used univariate filters, correlation screening, mRMR, and LASSO before training classifiers (logistic regression, SVM, Random Forest, Extra-Trees, LightGBM).
Outcomes and Analysis.
Primary outcome: pCR at surgery (yes/no).
Secondary outcomes: model performance (AUC, sensitivity, specificity, PPV/NPV, calibration) and clinical utility by decision-curve analysis; disease-free survival by Kaplan-Meier analysis.
Ethics. Approved by the Ethics Committee of Nanjing Medical University; informed consent was waived given the retrospective design and use of de-identified data.
- Being tested
- Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT)
- Keywords
- Deep Learning, Multiple Instance Learning (MIL)
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT)Other
Adults with biopsy-confirmed ESCC received standard neoadjuvant immunochemotherapy before surgery (e.g., camrelizumab with paclitaxel plus cisplatin or carboplatin, typically 2 cycles every 2-3 weeks). Treatments were routine clinical care at participating centers and were not assigned by study protocol; this record captures the exposure for observational modeling of pathological complete response (pCR). Surgery (R0) occurred ~6-8 weeks after therapy.
| Study group | Role | What they receive |
|---|---|---|
| ESCC nIT+nCT Surgical Resection Cohort (Multicenter, China) | Adults with biopsy-confirmed esophageal squamous cell carcinoma treated at three centers in China who received standardized neoadjuvant immunotherapy plus taxane-platinum chemotherapy (e.g., camrelizumab with paclitaxel and cisplatin or carboplatin) before surgery. Pre-treatment venous-phase chest CT (1-5 mm slices) within 14 days of therapy start was analyzed to extract radiomics and 2.5D deep-learning/MIL features. All patients underwent R0 resection 6-8 weeks post-therapy; pathological complete response (pCR) was determined on surgical specimens. This is an observational cohort used to build and externally validate a multimodal model predicting pCR; no biospecimens are retained and no treatments are assigned by protocol. Receives: Other: Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) at Surgery
pCR is defined as no residual viable tumor in the resected specimen (esophagus and regional lymph nodes) after neoadjuvant immunotherapy plus chemotherapy. pCR status is determined from the postoperative surgical pathology report. This is an observational cohort; treatments were standard-of-care and not assigned by protocol. pCR is abstracted from medical records for all eligible patients.
Measured: At time of surgery after neoadjuvant therapy (~6-8 weeks post-treatment).
Secondary outcomes (1)
Diagnostic Performance of the Multimodal Model for Predicting pCR
Discrimination and diagnostic accuracy of the combined clinical+radiomics+2.5D MIL model to predict pathological complete response (AUC with 95% CI, sensitivity, specificity, PPV, NPV). Thresholds selected in training (e.g., Youden's J) are applied unchanged to validation and external cohorts; performance is computed on patient-level predictions.
Measured: From baseline CT (≤14 days before therapy start) to surgery (≈6-8 weeks post-therapy); analysis performed at study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Jan 2019
- Primary completion1 Dec 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Principal investigator, Zhiyun Xu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181850
- Sponsor's protocol ID
- KY-2024-373-01
- Other IDs
- 81903992
- Acronym
- pCR-ESCC
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because the study received ethics approval with a waiver of informed consent for retrospective use within participating centers, and broad external sharing was not contemplated. In addition, raw imaging data pose re-identification risks, and cross-institutional data-sharing agreements are not in place.
Publications
Fan L, Yang Z, Chang M, Chen Z, Wen Q. CT-based delta-radiomics nomogram to predict pathological complete response after neoadjuvant chemoradiotherapy in esophageal squamous cell carcinoma patients. J Transl Med. 2024 Jun 18;22(1):579. doi: 10.1186/s12967-024-05392-4.
PubMed 38890720Liu Y, Wang Y, Wang X, Xue L, Zhang H, Ma Z, Deng H, Yang Z, Sun X, Men Y, Ye F, Men K, Qin J, Bi N, Wang Q, Hui Z. MR radiomics predicts pathological complete response of esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy: a multicenter study. Cancer Imaging. 2024 Jan 23;24(1):16. doi: 10.1186/s40644-024-00659-x.
PubMed 38263134Guo X, Chen C, Zhao J, Wang C, Mei X, Shen J, Lv H, Han Y, Wang Q, Lv J, Chen H, Yan X, Liu Z, Zhang Z, Zhong Q, Jiang Y, Xu L, Li X, Qian D, Ma D, Ye M, Wang C, Wang Z, Lin J, Tian Z, Leng X, Li Z. Neoadjuvant Chemoradiotherapy vs Chemoimmunotherapy for Esophageal Squamous Cell Carcinoma. JAMA Surg. 2025 May 1;160(5):565-574. doi: 10.1001/jamasurg.2025.0220.
PubMed 40105813Zheng Y, Liang G, Yuan D, Liu X, Ba Y, Qin Z, Shen S, Li Z, Sun H, Liu B, Gao Q, Li P, Wang Z, Liu S, Zhu J, Wang H, Ma H, Liu Z, Zhao F, Zhang J, Zhang H, Wu D, Qu J, Ma J, Zhang P, Ma W, Yan M, Yu Y, Li Q, Zhang J, Xing W. Perioperative toripalimab plus neoadjuvant chemotherapy might improve outcomes in resectable esophageal cancer: an interim analysis of a phase III randomized clinical trial. Cancer Commun (Lond). 2024 Oct;44(10):1214-1227. doi: 10.1002/cac2.12604. Epub 2024 Sep 2.
PubMed 39221992
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Clinical, Radiomics, and 2.5D Deep Learning-Based Multiple Instance Learning Features for Predicting Pathological Complete Response in Esophageal Squamous Cell Carcinoma Following Neoadjuvant Immunotherapy and Chemotherapy: A Multicenter Comparative Study
- ClinicalTrials.gov ID
- NCT07181850
- Acronym / sponsor ID
- pCR-ESCC / KY-2024-373-01
- Keywords
- Deep Learning, Multiple Instance Learning (MIL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Cancer Institute & Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Sep 2025 (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 multicenter, retrospective cohort study reviews the medical records and CT scans of adults with esophageal squamous cell carcinoma (ESCC) who received neoadjuvant immunotherapy plus chemotherapy before surgery at three hospitals in China. The goal is to develop and validate a computer-assisted model that predicts which patients achieve a pathological complete response (pCR)-meaning no residual tumor is found at surgery-after preoperative treatment. Accurate pCR prediction may help clinicians personalize care and avoid unnecessary treatments in likely non-responders.
The study includes 363 patients. For each patient, routinely collected clinical information and preoperative venous-phase chest CT images were analyzed. From CT images, both radiomics features and features learned by a "2.5D" deep learning approach with multiple-instance learning (MIL) were extracted. These were combined with clinical variables to create a multimodal prediction model. Model performance will be evaluated using standard metrics and validated in internal and external cohorts.
Patients typically received two cycles of taxane-platinum chemotherapy (paclitaxel with cisplatin or carboplatin) combined with camrelizumab every 2-3 weeks before surgery; CT scans were performed within 14 days prior to starting therapy. Surgery (R0 resection) was performed 6-8 weeks after treatment, and pCR was determined by the postoperative pathology report.
This is an observational study; no treatments are assigned by protocol. The study was approved by the Ethics Committee of Nanjing Medical University, with informed consent waived due to the retrospective design.
Detailed description
Design and Setting. Multicenter, retrospective cohort study conducted at three affiliated hospitals in China. A total of 363 consecutive ESCC patients met eligibility criteria and were split into a training cohort (n=107), internal validation cohort (n=45), and two external test cohorts (n=129 and n=82).
Population. Inclusion criteria: biopsy-confirmed ESCC; locally advanced disease by AJCC 8th edition (cT1N1-T3N0-3M0) on contrast-enhanced CT; completion of standardized neoadjuvant chemo-immunotherapy; availability of high-quality venous-phase chest CT (slice thickness ≤5 mm) within 14 days before therapy; R0 resection 6-8 weeks post-treatment; and a definitive postoperative pathology report documenting pCR. Key exclusions: non-squamous histology, distant metastasis, synchronous malignancies, poor/no venous-phase imaging, slice thickness >5 mm, severe artifacts, incomplete tumor visualization, incomplete treatment, or missing endpoints.
Neoadjuvant Regimen and Imaging. Patients generally received two cycles of taxane-platinum chemotherapy (paclitaxel plus cisplatin or carboplatin) combined with camrelizumab every 2-3 weeks prior to surgery. CT imaging was standardized to venous-phase contrast with 1-5 mm slices; scans without venous phase or >5 mm thickness were excluded. Tumor volumes were delineated by two radiologists; disagreements were adjudicated by a senior radiologist, and features were harmonized via resampling and intensity normalization.
Feature Extraction and Modeling. The pipeline integrated: (1) clinical variables; (2) conventional CT radiomics features (shape, first-order, GLCM, GLRLM, GLSZM, etc.); and (3) 2.5D deep learning slice embeddings aggregated to the patient level using multiple-instance learning (MIL). The 2.5D approach uses adjacent slices in axial/sagittal/coronal planes with ResNet backbones; attention-based MIL plus histogram/BoW-TF-IDF descriptors summarized slice-level predictions. Feature selection used univariate filters, correlation screening, mRMR, and LASSO before training classifiers (logistic regression, SVM, Random Forest, Extra-Trees, LightGBM).
Outcomes and Analysis.
Primary outcome: pCR at surgery (yes/no).
Secondary outcomes: model performance (AUC, sensitivity, specificity, PPV/NPV, calibration) and clinical utility by decision-curve analysis; disease-free survival by Kaplan-Meier analysis.
Ethics. Approved by the Ethics Committee of Nanjing Medical University; informed consent was waived given the retrospective design and use of de-identified data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESCC nIT+nCT Surgical Resection Cohort (Multicenter, China) | – | Other: Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT)Adults with biopsy-confirmed esophageal squamous cell carcinoma treated at three centers in China who received standardized neoadjuvant immunotherapy plus taxane-platinum chemotherapy (e.g., camrelizumab with paclitaxel and cisplatin or carboplatin) before surgery. Pre-treatment venous-phase chest CT (1-5 mm slices) within 14 days of therapy start was analyzed to extract radiomics and 2.5D deep-learning/MIL features. All patients underwent R0 resection 6-8 weeks post-therapy; pathological complete response (pCR) was determined on surgical specimens. This is an observational cohort used to build and externally validate a multimodal model predicting pCR; no biospecimens are retained and no treatments are assigned by protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with biopsy-confirmed ESCC treated at three participating centers in China. Patients received standard neoadjuvant chemo-immunotherapy (e.g., camrelizumab with paclitaxel and cisplatin or carboplatin), had pre-treatment venous-phase chest CT within 14 days, and underwent R0 resection 6-8 weeks post-therapy. pCR status was determined from surgical pathology. Sites include: The Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University; Nanjing Medical University Affiliated Cancer Hospital \& Jiangsu Cancer Hospital \& Jiangsu Institute of Cancer Research; and Nanjing Drum Tower Hospital.
Key inclusion criteria (4 listed)
- Biopsy-confirmed esophageal squamous cell carcinoma (ESCC). Locally advanced disease per AJCC 8th ed. (cT1N1-T3N0-3M0) on contrast-enhanced CT.
- Completed standardized neoadjuvant chemo-immunotherapy (e.g., paclitaxel + cisplatin/carboplatin with camrelizumab every 2-3 weeks) prior to surgery.
- High-quality venous-phase chest CT (slice thickness ≤5 mm) obtained within 14 days before therapy start.
- Underwent R0 resection 6-8 weeks after therapy. Availability of a definitive postoperative pathology report to ascertain pCR status.
Key exclusion criteria (2 listed)
- Non-squamous histology; distant metastasis (M1); synchronous malignancies. Inadequate imaging quality (no venous phase, slice thickness >5 mm, severe artifacts, or incomplete tumor visualization).
- Did not complete the full treatment course or had missing endpoints (e.g., no pathological response record or lost to follow-up).
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 |
|---|---|---|
| Standard-of-Care Neoadjuvant Immunochemotherapy (nIT+nCT)Adults with biopsy-confirmed ESCC received standard neoadjuvant immunochemotherapy before surgery (e.g., camrelizumab with paclitaxel plus cisplatin or carboplatin, typically 2 cycles every 2-3 weeks). Treatments were routine clinical care at participating centers and were not assigned by study protocol; this record captures the exposure for observational modeling of pathological complete response (pCR). Surgery (R0) occurred ~6-8 weeks after therapy. | Other | ESCC nIT+nCT Surgical Resection Cohort (Multicenter, China) |
Primary outcome
Pathological Complete Response (pCR) at Surgery
Time frame: At time of surgery after neoadjuvant therapy (~6-8 weeks post-treatment).
pCR is defined as no residual viable tumor in the resected specimen (esophagus and regional lymph nodes) after neoadjuvant immunotherapy plus chemotherapy. pCR status is determined from the postoperative surgical pathology report. This is an observational cohort; treatments were standard-of-care and not assigned by protocol. pCR is abstracted from medical records for all eligible patients.
1 secondary outcome
Diagnostic Performance of the Multimodal Model for Predicting pCR
Time frame: From baseline CT (≤14 days before therapy start) to surgery (≈6-8 weeks post-therapy); analysis performed at study completion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Results publication: PubMed 38890720Fan L, Yang Z, Chang M, Chen Z, Wen Q. CT-based delta-radiomics nomogram to predict pathological complete response after neoadjuvant chemoradiotherapy in esophageal squamous cell carcinoma patients. J Transl Med. 2024 Jun 18;22(1):579. doi: 10.1186/s12967-024-05392-4.
- Results publication: PubMed 38263134Liu Y, Wang Y, Wang X, Xue L, Zhang H, Ma Z, Deng H, Yang Z, Sun X, Men Y, Ye F, Men K, Qin J, Bi N, Wang Q, Hui Z. MR radiomics predicts pathological complete response of esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy: a multicenter study. Cancer Imaging. 2024 Jan 23;24(1):16. doi: 10.1186/s40644-024-00659-x.
- Results publication: PubMed 40105813Guo X, Chen C, Zhao J, Wang C, Mei X, Shen J, Lv H, Han Y, Wang Q, Lv J, Chen H, Yan X, Liu Z, Zhang Z, Zhong Q, Jiang Y, Xu L, Li X, Qian D, Ma D, Ye M, Wang C, Wang Z, Lin J, Tian Z, Leng X, Li Z. Neoadjuvant Chemoradiotherapy vs Chemoimmunotherapy for Esophageal Squamous Cell Carcinoma. JAMA Surg. 2025 May 1;160(5):565-574. doi: 10.1001/jamasurg.2025.0220.
- Results publication: PubMed 39221992Zheng Y, Liang G, Yuan D, Liu X, Ba Y, Qin Z, Shen S, Li Z, Sun H, Liu B, Gao Q, Li P, Wang Z, Liu S, Zhu J, Wang H, Ma H, Liu Z, Zhao F, Zhang J, Zhang H, Wu D, Qu J, Ma J, Zhang P, Ma W, Yan M, Yu Y, Li Q, Zhang J, Xing W. Perioperative toripalimab plus neoadjuvant chemotherapy might improve outcomes in resectable esophageal cancer: an interim analysis of a phase III randomized clinical trial. Cancer Commun (Lond). 2024 Oct;44(10):1214-1227. doi: 10.1002/cac2.12604. Epub 2024 Sep 2.
- Individual participant dataSharing planned: No. IPD will not be shared because the study received ethics approval with a waiver of informed consent for retrospective use within participating centers, and broad external sharing was not contemplated. In addition, raw imaging data pose re-identification risks, and cross-institutional data-sharing agreements are not in place.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma and Pathological Complete Response, run by Nanjing Medical University at 1 site in China.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) at Surgery (time frame: At time of surgery after neoadjuvant therapy (~6-8 weeks post-treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07181850, which also lists 4 linked publications.
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 18 Sep 2025.