Esophageal Squamous Cell CarcinomaNCT07858630
Radiotherapy Target Volume Delineation in Locally Advanced Esophageal Cancer in the Immunotherapy Era
An observational study of Esophageal Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This prospective observational cohort study will evaluate different radiotherapy target volume delineation patterns in patients with locally advanced esophageal squamous cell carcinoma receiving radiotherapy combined with immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- GTV-CTV Longitudinal Margin and Regional Lymph Node Irradiation Strategy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2026to 31 Aug 2036
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced esophageal squamous cell carcinoma who are treated at the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College and are considered suitable for definitive or preoperative radiotherapy combined with immunotherapy will be prospectively and consecutively enrolled. Treatment decisions will be made according to routine clinical practice. Participants will be followed to evaluate the association between actual radiotherapy target volume delineation patterns and locoregional control, recurrence, survival, toxicity, lymphocyte reduction, and immunotherapy completion.
Who may be able to join
- Age 18 to 80 years, regardless of sex.
- Histologically confirmed esophageal squamous cell carcinoma.
- Clinical stage cT2-4aN0-3M0, or considered by a multidisciplinary team to be suitable for definitive immunotherapy combined with radiotherapy or preoperative immunotherapy combined with radiotherapy.
- Planned to receive one of the following modern precision radiotherapy techniques: IMRT, VMAT, TOMO, proton therapy, or heavy-ion radiotherapy.
- Contrast-enhanced CT completed before radiotherapy; endoscopy, EUS, PET/CT, or MRI is recommended when clinically appropriate to assist target volume delineation.
- ECOG performance status of 0-2.
- Expected survival of at least 6 months.
- Able to understand the study and provide written informed consent.
Who cannot join
- Presence of distant metastasis or malignant pleural or peritoneal effusion.
- Previous thoracic radiotherapy that may affect the current target volume design or dose constraints.
- Pre-existing esophagotracheal fistula, esophagoaortic fistula, or a high risk of perforation considered unsuitable for radiotherapy.
- Active interstitial lung disease, severe infection, or uncontrolled autoimmune disease considered unsuitable for immunotherapy.
- Severe missing data that prevent determination of the actual CTV margin, lymph node irradiation extent, or major study outcomes.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
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, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Xin Wang, PhD, +86-10-87787635, beryl_wx2000@163.com
Chao Xi Cao, caoxichao2024@163.com
About this study
Official title: A Prospective Cohort Study of Radiotherapy Target Volume Delineation Patterns in Locally Advanced Esophageal Cancer in the Immunotherapy Era
This prospective observational cohort study will evaluate different radiotherapy target volume delineation patterns in patients with locally advanced esophageal squamous cell carcinoma receiving radiotherapy combined with immunotherapy.
In routine clinical practice, physicians may use different margins around the primary tumor and different approaches to regional lymph node irradiation. The study will not assign participants to a specific radiotherapy strategy. Instead, participants will receive treatment according to routine clinical practice, and the actual radiotherapy plans will be recorded and analyzed.
The study will compare locoregional tumor control, recurrence patterns, survival, treatment-related toxicity, lymphocyte reduction, and completion of immunotherapy among patients receiving different target volume strategies. The main objective is to evaluate 2-year locoregional recurrence-free survival and to identify radiotherapy approaches that may achieve effective tumor control while reducing unnecessary radiation exposure and treatment-related toxicity.
Read the detailed description
This is a prospective, non-interventional observational cohort study of patients with locally advanced esophageal squamous cell carcinoma treated with radiotherapy in combination with immunotherapy in routine clinical practice. Treatment decisions, including radiotherapy target volume delineation and systemic therapy, will be made by the treating physicians according to the patient's clinical condition and routine clinical practice and will not be assigned by the study protocol.
Eligible participants will be prospectively followed, and clinical, imaging, pathological, radiotherapy planning, systemic treatment, laboratory, toxicity, and follow-up data will be collected. Participants will be classified according to the radiotherapy strategy actually received, particularly the longitudinal gross tumor volume-to-clinical target volume (GTV-CTV) margin and the extent of regional lymph node irradiation, including involved-field irradiation and approaches incorporating partial elective nodal irradiation.
The primary objective is to compare 2-year locoregional recurrence-free survival among patients receiving different target volume delineation strategies. Additional outcomes include marginal and regional recurrence patterns, overall survival, treatment-related toxicity, lymphocyte reduction, immunotherapy completion, and other treatment outcomes.
The study will also evaluate whether clinical and biological factors, including tumor location and length, T and N stage, lymph node burden, PET/CT metabolic parameters, PD-L1 combined positive score, circulating tumor DNA status, and radiotherapy dosimetric parameters, are associated with the effectiveness and safety of different target volume strategies. Target trial emulation, propensity score methods, and multivariable models will be used where appropriate to reduce confounding and to explore factors associated with recurrence and toxicity.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- GTV-CTV Longitudinal Margin, Regional Lymph Node Irradiation Strategy
- Keywords
- Locally Advanced Esophageal Cancer, Radiotherapy, Immunotherapy, Clinical Target Volume, Target Volume Delineation, GTV-CTV Margin, Regional Lymph Node Irradiation
- 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.
GTV-CTV Longitudinal MarginRadiation
The longitudinal margin from the gross tumor volume (GTV) to the clinical target volume (CTV) actually used in routine clinical practice will be recorded and analyzed. The study protocol does not assign a specific margin.
Regional Lymph Node Irradiation StrategyRadiation
The extent of regional lymph node irradiation actually used in routine clinical practice, including involved-field irradiation and approaches incorporating partial elective nodal irradiation, will be recorded and analyzed. The study protocol does not assign a specific nodal irradiation strategy.
| Study group | Role | What they receive |
|---|---|---|
| Locally Advanced ESCC Cohort | Patients with locally advanced esophageal squamous cell carcinoma who receive radiotherapy combined with immunotherapy in routine clinical practice will be prospectively enrolled. Treatment and radiotherapy target volume delineation will not be assigned by the study protocol. Patients will be characterized according to the radiotherapy strategy actually received, including the longitudinal GTV-CTV margin and the extent of regional lymph node irradiation. Clinical, imaging, pathological, dosimetric, treatment, toxicity, and follow-up data will be prospectively collected to evaluate locoregional control, recurrence patterns, survival, lymphocyte reduction, and immunotherapy completion. Receives: Radiation: GTV-CTV Longitudinal Margin; Radiation: Regional Lymph Node Irradiation Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Locoregional Recurrence-Free Survival
Locoregional recurrence-free survival (LRFS) is defined as the time from the start of radiotherapy to locoregional tumor recurrence, death from any cause, loss to follow-up, or the last follow-up, according to the study protocol. The 2-year LRFS rate will be compared among patients receiving different radiotherapy target volume delineation strategies.
Measured: Up to 2 years from the start of radiotherapy
Secondary outcomes (3)
2-Year Overall Survival
Overall survival (OS) is defined as the time from the start of radiotherapy to death from any cause, loss to follow-up, or the last follow-up. The 2-year overall survival rate will be evaluated among participants receiving different radiotherapy target volume strategies.
Measured: Up to 2 years from radiotherapy
Marginal and Regional Recurrence Rate
The proportion of participants who develop marginal recurrence or regional lymph node recurrence during follow-up. Recurrence will be determined by pathological or cytological confirmation when available, or by serial imaging showing a new or progressively enlarging lesion consistent with recurrence.
Measured: Up to 2 years from radiotherapy
Incidence of Grade 3 or Higher Treatment-Related Toxicity
The incidence of grade 3 or higher treatment-related adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Toxicities of interest include radiotherapy-related and systemic treatment-related adverse events.
Measured: From treatment initiation through 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start23 Aug 2026
- Primary completion30 Jul 2034 (estimated)
- Study completion31 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858630
- Sponsor's protocol ID
- 26/557-6281
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with external researchers because the current study protocol does not include a plan for external sharing of participant-level data. Study data will be stored with controlled access and will be available only to authorized study personnel. Study results will be reported in aggregate form to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Radiotherapy Target Volume Delineation Patterns in Locally Advanced Esophageal Cancer in the Immunotherapy Era
- ClinicalTrials.gov ID
- NCT07858630
- Acronym / sponsor ID
- 26/557-6281
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Locally Advanced Esophageal Cancer, Radiotherapy, Immunotherapy, Clinical Target Volume, Target Volume Delineation, GTV-CTV Margin, Regional Lymph Node Irradiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 23 Aug 2026 (actual)
- Primary completion
- 30 Jul 2034 (estimated)
- Study completion
- 31 Aug 2036 (estimated)
- First posted
- 5 Oct 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 prospective observational cohort study will evaluate different radiotherapy target volume delineation patterns in patients with locally advanced esophageal squamous cell carcinoma receiving radiotherapy combined with immunotherapy.
In routine clinical practice, physicians may use different margins around the primary tumor and different approaches to regional lymph node irradiation. The study will not assign participants to a specific radiotherapy strategy. Instead, participants will receive treatment according to routine clinical practice, and the actual radiotherapy plans will be recorded and analyzed.
The study will compare locoregional tumor control, recurrence patterns, survival, treatment-related toxicity, lymphocyte reduction, and completion of immunotherapy among patients receiving different target volume strategies. The main objective is to evaluate 2-year locoregional recurrence-free survival and to identify radiotherapy approaches that may achieve effective tumor control while reducing unnecessary radiation exposure and treatment-related toxicity.
Detailed description
This is a prospective, non-interventional observational cohort study of patients with locally advanced esophageal squamous cell carcinoma treated with radiotherapy in combination with immunotherapy in routine clinical practice. Treatment decisions, including radiotherapy target volume delineation and systemic therapy, will be made by the treating physicians according to the patient's clinical condition and routine clinical practice and will not be assigned by the study protocol.
Eligible participants will be prospectively followed, and clinical, imaging, pathological, radiotherapy planning, systemic treatment, laboratory, toxicity, and follow-up data will be collected. Participants will be classified according to the radiotherapy strategy actually received, particularly the longitudinal gross tumor volume-to-clinical target volume (GTV-CTV) margin and the extent of regional lymph node irradiation, including involved-field irradiation and approaches incorporating partial elective nodal irradiation.
The primary objective is to compare 2-year locoregional recurrence-free survival among patients receiving different target volume delineation strategies. Additional outcomes include marginal and regional recurrence patterns, overall survival, treatment-related toxicity, lymphocyte reduction, immunotherapy completion, and other treatment outcomes.
The study will also evaluate whether clinical and biological factors, including tumor location and length, T and N stage, lymph node burden, PET/CT metabolic parameters, PD-L1 combined positive score, circulating tumor DNA status, and radiotherapy dosimetric parameters, are associated with the effectiveness and safety of different target volume strategies. Target trial emulation, propensity score methods, and multivariable models will be used where appropriate to reduce confounding and to explore factors associated with recurrence and toxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally Advanced ESCC Cohort | – | Radiation: GTV-CTV Longitudinal Margin, Radiation: Regional Lymph Node Irradiation StrategyPatients with locally advanced esophageal squamous cell carcinoma who receive radiotherapy combined with immunotherapy in routine clinical practice will be prospectively enrolled. Treatment and radiotherapy target volume delineation will not be assigned by the study protocol. Patients will be characterized according to the radiotherapy strategy actually received, including the longitudinal GTV-CTV margin and the extent of regional lymph node irradiation. Clinical, imaging, pathological, dosimetric, treatment, toxicity, and follow-up data will be prospectively collected to evaluate locoregional control, recurrence patterns, survival, lymphocyte reduction, and immunotherapy completion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced esophageal squamous cell carcinoma who are treated at the National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College and are considered suitable for definitive or preoperative radiotherapy combined with immunotherapy will be prospectively and consecutively enrolled. Treatment decisions will be made according to routine clinical practice. Participants will be followed to evaluate the association between actual radiotherapy target volume delineation patterns and locoregional control, recurrence, survival, toxicity, lymphocyte reduction, and immunotherapy completion.
Key inclusion criteria (8 listed)
- Age 18 to 80 years, regardless of sex.
- Histologically confirmed esophageal squamous cell carcinoma.
- Clinical stage cT2-4aN0-3M0, or considered by a multidisciplinary team to be suitable for definitive immunotherapy combined with radiotherapy or preoperative immunotherapy combined with radiotherapy.
- Planned to receive one of the following modern precision radiotherapy techniques: IMRT, VMAT, TOMO, proton therapy, or heavy-ion radiotherapy.
- Contrast-enhanced CT completed before radiotherapy; endoscopy, EUS, PET/CT, or MRI is recommended when clinically appropriate to assist target volume delineation.
Key exclusion criteria (6 listed)
- Presence of distant metastasis or malignant pleural or peritoneal effusion.
- Previous thoracic radiotherapy that may affect the current target volume design or dose constraints.
- Pre-existing esophagotracheal fistula, esophagoaortic fistula, or a high risk of perforation considered unsuitable for radiotherapy.
- Active interstitial lung disease, severe infection, or uncontrolled autoimmune disease considered unsuitable for immunotherapy.
- Severe missing data that prevent determination of the actual CTV margin, lymph node irradiation extent, or major study outcomes.
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 |
|---|---|---|
| GTV-CTV Longitudinal MarginThe longitudinal margin from the gross tumor volume (GTV) to the clinical target volume (CTV) actually used in routine clinical practice will be recorded and analyzed. The study protocol does not assign a specific margin. | Radiation | Locally Advanced ESCC Cohort |
| Regional Lymph Node Irradiation StrategyThe extent of regional lymph node irradiation actually used in routine clinical practice, including involved-field irradiation and approaches incorporating partial elective nodal irradiation, will be recorded and analyzed. The study protocol does not assign a specific nodal irradiation strategy. | Radiation | Locally Advanced ESCC Cohort |
Primary outcome
2-Year Locoregional Recurrence-Free Survival
Time frame: Up to 2 years from the start of radiotherapy
Locoregional recurrence-free survival (LRFS) is defined as the time from the start of radiotherapy to locoregional tumor recurrence, death from any cause, loss to follow-up, or the last follow-up, according to the study protocol. The 2-year LRFS rate will be compared among patients receiving different radiotherapy target volume delineation strategies.
3 secondary outcomes
2-Year Overall Survival
Time frame: Up to 2 years from radiotherapy
Marginal and Regional Recurrence Rate
Time frame: Up to 2 years from radiotherapy
Incidence of Grade 3 or Higher Treatment-Related Toxicity
Time frame: From treatment initiation through 2-year follow-up
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 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with external researchers because the current study protocol does not include a plan for external sharing of participant-level data. Study data will be stored with controlled access and will be available only to authorized study personnel. Study results will be reported in aggregate form to protect participant privacy and confidentiality.
Related trials for Esophageal Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Recruiting
Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial
Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8, Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
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.
National Cancer Center/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 Squamous Cell Carcinoma, 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. 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?
2-Year Locoregional Recurrence-Free Survival (time frame: Up to 2 years from the start of radiotherapy). 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 5 Oct 2026.