Esophageal CancerNCT06889402
Prognostic Analysis of Esophageal Cancer with Complete Pathological Response After Neoadjuvant Therapy
An observational study of Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Esophageal cancer is one of the most common malignant tumors worldwide, with high invasiveness and lethality. Currently, the treatment for resectable locally advanced esophageal cancer mainly consists of a treatment model centered on surgical treatment with the participation of multiple disciplines. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Neoadjuvant therapy with PD-L1 inhibitor
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Apr 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with thoracic esophageal squamous cell carcinoma treated neoadjvant treatment followed by esophagectomy from 2018 to 2023,whose preoperative clnical stage was cT1N+M0/cT2-4aN0-3M0, with potential resectability and the ypstage ypT0N0M0（complete pathological response ）
Who may be able to join
- Patients treated neoadjvant treatment followed by esophagectomy from 2018 to 2023
- Patients with thoracic esophageal squamous cell carcinoma
- The preoperative clnical stage is cT1N+M0/cT2-4aN0-3M0, with potential resectability
- Patients with complete pathological response (ypT0N0M0)
- Without distant metastasis was found in the preoperative examinations, and the tumor did not directly invade the pancreas, spleen, trachea, aorta or other adjacent organs such as the lungs
Who cannot join
- Patients with previous history of malignant tumors
- Patients with multiple primary cancers
- Deficient neoadjuvant treatment or salvage surgery
- Incomplete clinical data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Section of Esophageal and Mediastinal Oncology, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Xiufeng Wei, 15836176692, 383775613@qq.com
Xiankai Chen, 18239900587, xiufeng-wei1990@hotmail.com
About this study
Official title: Risk Factors for Recurrence and Survival Outcomes of Esophageal Squamous Cell Carcinoma Patients with Complete Pathological Response After Neoadjuvant Therapy：A Multicenter Study
Esophageal cancer is one of the most common malignant tumors worldwide, with high invasiveness and lethality. Currently, the treatment for resectable locally advanced esophageal cancer mainly consists of a treatment model centered on surgical treatment with the participation of multiple disciplines. Neoadjuvant treatment regimens include chemotherapy, chemoradiotherapy, and chemotherapy combined with immunotherapy. Complete pathological response (pCR)is currently regarded as one of the important indicators for evaluating the efficacy of neoadjuvant treatment. Previous studies have shown that 14%-39% of patients with complete pathological response after neoadjuvant treatment still experience recurrence and metastasis within two years after surgery, suggesting that pCR after esophageal cancer surgery does not mean clinical cure. Perhaps there is a highly risk clinical subgroup need to research. Therefore, based on the prospective clinical database of the National Cancer Center and in cooperation with multiple national cancer regional medical centers, this study analyzes and explores the prognosis of patients with locally advanced esophageal squamous cell carcinoma with pCR after neoadjuvant treatment, characterized by the Chinese population.
- Conditions
- Esophageal Cancer
- Being tested
- Neoadjuvant therapy with PD-L1 inhibitor
- Keywords
- Complete pathological response, neoadjuvant, Recurrence, Esophageal Squamous Cell Carcinoma, Survival
- Medical subject headings
- Esophageal Neoplasms, Pathologic Complete Response, Recurrence, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant therapy with PD-L1 inhibitorProcedure or surgery
Also called neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy
During neoadjuvant treatment, patients may receive neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy, or neoadjuvant chemotherapy combined with immunotherapy during the perioperative period.
| Study group | Role | What they receive |
|---|---|---|
| Recurrence | Patients with complete pathological response after neoadjuvant treatment experience recurrence or metastasis after surgery Receives: Procedure: Neoadjuvant therapy with PD-L1 inhibitor | |
| Non-recurrence | Patients with complete pathological response after neoadjuvant treatment without recurrence or metastasis after surgery Receives: Procedure: Neoadjuvant therapy with PD-L1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival
The time from the postoperative period of the patient to the first occurrence of recurrence or metastasis.
Measured: The postoperative follow-up period should last for at least one year.
Secondary outcomes (1)
Overall Survival Rate
the proportion of patients who are still alive for a certain period of time after surgery among all the patients who have undergone the surgical operation.
Measured: The postoperative follow-up period should last for at least one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion30 Apr 2025 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889402
- Sponsor's protocol ID
- AESCNT01
- Status last verified
- Dec 2024
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Recurrence and Survival Outcomes of Esophageal Squamous Cell Carcinoma Patients with Complete Pathological Response After Neoadjuvant Therapy：A Multicenter Study
- ClinicalTrials.gov ID
- NCT06889402
- Acronym / sponsor ID
- AESCNT01
- Conditions
- Esophageal Cancer
- Keywords
- Complete pathological response, neoadjuvant, Recurrence, Esophageal Squamous Cell Carcinoma, Survival
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 21 Mar 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.
Esophageal cancer is one of the most common malignant tumors worldwide, with high invasiveness and lethality. Currently, the treatment for resectable locally advanced esophageal cancer mainly consists of a treatment model centered on surgical treatment with the participation of multiple disciplines. Neoadjuvant treatment regimens include chemotherapy, chemoradiotherapy, and chemotherapy combined with immunotherapy. Complete pathological response (pCR)is currently regarded as one of the important indicators for evaluating the efficacy of neoadjuvant treatment. Previous studies have shown that 14%-39% of patients with complete pathological response after neoadjuvant treatment still experience recurrence and metastasis within two years after surgery, suggesting that pCR after esophageal cancer surgery does not mean clinical cure. Perhaps there is a highly risk clinical subgroup need to research. Therefore, based on the prospective clinical database of the National Cancer Center and in cooperation with multiple national cancer regional medical centers, this study analyzes and explores the prognosis of patients with locally advanced esophageal squamous cell carcinoma with pCR after neoadjuvant treatment, characterized by the Chinese population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrence | – | Procedure: Neoadjuvant therapy with PD-L1 inhibitorPatients with complete pathological response after neoadjuvant treatment experience recurrence or metastasis after surgery |
| Non-recurrence | – | Procedure: Neoadjuvant therapy with PD-L1 inhibitorPatients with complete pathological response after neoadjuvant treatment without recurrence or metastasis after surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thoracic esophageal squamous cell carcinoma treated neoadjvant treatment followed by esophagectomy from 2018 to 2023,whose preoperative clnical stage was cT1N+M0/cT2-4aN0-3M0, with potential resectability and the ypstage ypT0N0M0（complete pathological response ）
Key inclusion criteria (5 listed)
- Patients treated neoadjvant treatment followed by esophagectomy from 2018 to 2023
- Patients with thoracic esophageal squamous cell carcinoma
- The preoperative clnical stage is cT1N+M0/cT2-4aN0-3M0, with potential resectability
- Patients with complete pathological response (ypT0N0M0)
- Without distant metastasis was found in the preoperative examinations, and the tumor did not directly invade the pancreas, spleen, trachea, aorta or other adjacent organs such as the lungs
Key exclusion criteria (4 listed)
- Patients with previous history of malignant tumors
- Patients with multiple primary cancers
- Deficient neoadjuvant treatment or salvage surgery
- Incomplete clinical data
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 |
|---|---|---|
| Neoadjuvant therapy with PD-L1 inhibitorAlso: neoadjuvant chemotherapy, neoadjuvant chemoradiotherapyDuring neoadjuvant treatment, patients may receive neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy, or neoadjuvant chemotherapy combined with immunotherapy during the perioperative period. | Procedure or surgery | Non-recurrence, Recurrence |
Primary outcome
Disease-Free Survival
Time frame: The postoperative follow-up period should last for at least one year.
The time from the postoperative period of the patient to the first occurrence of recurrence or metastasis.
1 secondary outcome
Overall Survival Rate
Time frame: The postoperative follow-up period should last for at least one year.
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 21 Mar 2025.
- 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.
Section of Esophageal and Mediastinal Oncology, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
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 Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 5 inclusion and 4 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 21 Mar 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (time frame: The postoperative follow-up period should last for at least one year.). 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 21 Mar 2025.