Esophageal Squamous Cell Carcinoma (ESCC)NCT07080437
An Observational Study on the Safety and Efficacy of Immunotherapy Combined With Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma
An observational study of Esophageal Squamous Cell Carcinoma (ESCC), run by Three Gorges Hospital of Chongqing University at 1 site in China.
Trial summary
Title: Observational Study on the Safety and Efficacy of Immunotherapy Combined with Concurrent Chemoradiotherapy in Elderly Patients with Esophageal Squamous Cell Carcinoma Study Purpose: This single-center, open-label, retrospective study aims to evaluate the safety and efficacy of immunotherapy combined with… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Immunotherapy Therapy
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Nov 2026
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population consists of elderly patients (≥70 years) with histologically confirmed ESCC who are not suitable for surgery or refuse surgery but are able to tolerate anti-tumor treatment. The inclusion and exclusion criteria are designed to ensure the safety and efficacy of the study while maintaining a representative patient population for the research objectives.
Who may be able to join
- Voluntary participation with written informed consent. Age ≥70 years, regardless of gender. Histologically or cytologically confirmed ESCC. Inoperable or refusal of surgery, with tolerance for anti-tumor treatment. ECOG performance status 0-2. Expected survival ≥6 months. No severe abnormalities in hematologic, cardiac, pulmonary, hepatic, or renal function, and no immunodeficiencies.
Who cannot join
- No severe abnormalities in hematologic, cardiac, pulmonary, hepatic, or renal function, and no immunodeficiencies.
- Distant organ metastasis (excluding supraclavicular lymph nodes). Previous esophageal fistula, perforation, or pre-treatment for malignancy. Prior thoracic radiotherapy. Active autoimmune diseases or history of autoimmune diseases. Previous or ongoing PD-1 inhibitor treatment or participation in other interventional clinical studies.
- Allergy to large protein formulations or components of S-1 capsules. Uncontrolled cardiac conditions. Immunodeficiencies (e.g., HIV infection), active hepatitis B or C, or active tuberculosis.
- Active infection or unexplained fever >38.5°C within 2 weeks before screening. History of other malignancies within 5 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ).
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
Affiliated Shangxia Hospital of Chongqing University
Chongqing, Chongqing Municipality
About this study
Title: Observational Study on the Safety and Efficacy of Immunotherapy Combined with Concurrent Chemoradiotherapy in Elderly Patients with Esophageal Squamous Cell Carcinoma
Study Purpose:
Read more
This single-center, open-label, retrospective study aims to evaluate the safety and efficacy of immunotherapy combined with concurrent chemoradiotherapy (CCRT) in elderly patients with esophageal squamous cell carcinoma (ESCC). The primary objectives include assessing the objective response rate (ORR), overall survival (OS), progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), R0 resection rate, adverse events (AEs), and potential predictive biomarkers in elderly patients receiving this treatment regimen.
Condition Studied:
Esophageal Squamous Cell Carcinoma (ESCC) in elderly patients (≥70 years).
Intervention:
Participants will receive concurrent chemoradiotherapy (CCRT) combined with immunotherapy. The study will retrospectively analyze the outcomes of patients treated between January 2022 and March 2025.
Study Design:
This is a retrospective, single-arm study. Patients aged 70 years or older with histologically confirmed ESCC (stages IB to IVB according to the 6th edition of the American Joint Committee on Cancer) will be included. Patients will undergo radiotherapy with concurrent chemotherapy and immunotherapy. Follow-up evaluations will be conducted every 3 months until disease progression or up to 2 years.
Eligibility Criteria:
Inclusion Criteria:
Voluntary participation with written informed consent. Age ≥70 years, regardless of gender. Histologically or cytologically confirmed ESCC. Inoperable or refusal of surgery, with tolerance for anti-tumor treatment. ECOG performance status 0-2. Expected survival ≥6 months. No severe abnormalities in hematologic, cardiac, pulmonary, hepatic, or renal function, and no immunodeficiencies.
Exclusion Criteria:
Distant organ metastasis (excluding supraclavicular lymph nodes). Previous esophageal fistula, perforation, or pre-treatment for malignancy. Prior thoracic radiotherapy. Active autoimmune diseases or history of autoimmune diseases. Previous or ongoing PD-1 inhibitor treatment or participation in other interventional clinical studies.
Allergy to large protein formulations or components of S-1 capsules. Uncontrolled cardiac conditions. Immunodeficiencies (e.g., HIV infection), active hepatitis B or C, or active tuberculosis.
Active infection or unexplained fever >38.5°C within 2 weeks before screening. History of other malignancies within 5 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ).
Scientific and Social Value:
This study aims to explore effective treatment options for elderly ESCC patients and enhance the influence of the discipline in this field.
Recruitment and Informed Consent:
Participants will be recruited through physician referrals. Informed consent will be obtained from all participants, ensuring their privacy and confidentiality.
Outcome Measures:
Primary outcomes: ORR, OS, PFS, DCR, DoR, R0 resection rate, and AEs. Secondary outcomes: Identification of potential predictive biomarkers.
Study Duration:
The study will cover a period from January 2022 to March 2025, with follow-up evaluations conducted every 3 months until disease progression or up to 2 years.
Publication Plan:
The results of this study will be published in high-quality scientific journals.
- Being tested
- Immunotherapy Therapy
- 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.
Immunotherapy TherapyDrug
Patients will receive concurrent chemoradiotherapy (CCRT) combined with immunotherapy. The treatment includes:
Radiotherapy: Individualized radiotherapy targeting the tumor. Concurrent Chemotherapy: Platinum-based doublet chemotherapy (e.g., cisplatin + fluorouracil or S-1) administered during radiotherapy.
Immunotherapy: PD-1 inhibitor (e.g., tislelizumab) used to enhance the immune response against cancer cells.
The treatment will be tailored to each patient's condition, with regular follow-up assessments every 3 months for up to 2 years to monitor efficacy and safety.
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Imaging assessments every 3 months after treatment initiation until disease progression or up to 2 years.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Mar 2021
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (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 Carcinoma (ESCC)Studies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Three Gorges Hospital of Chongqing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HanZhang, Three Gorges Hospital of Chongqing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080437
- Sponsor's protocol ID
- TGHEC001
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Safety and Efficacy of Immunotherapy Combined With Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07080437
- Acronym / sponsor ID
- TGHEC001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Three Gorges Hospital of Chongqing UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 23 Jul 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.
Title: Observational Study on the Safety and Efficacy of Immunotherapy Combined with Concurrent Chemoradiotherapy in Elderly Patients with Esophageal Squamous Cell Carcinoma
Study Purpose:
This single-center, open-label, retrospective study aims to evaluate the safety and efficacy of immunotherapy combined with concurrent chemoradiotherapy (CCRT) in elderly patients with esophageal squamous cell carcinoma (ESCC). The primary objectives include assessing the objective response rate (ORR), overall survival (OS), progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), R0 resection rate, adverse events (AEs), and potential predictive biomarkers in elderly patients receiving this treatment regimen.
Condition Studied:
Esophageal Squamous Cell Carcinoma (ESCC) in elderly patients (≥70 years).
Intervention:
Participants will receive concurrent chemoradiotherapy (CCRT) combined with immunotherapy. The study will retrospectively analyze the outcomes of patients treated between January 2022 and March 2025.
Study Design:
This is a retrospective, single-arm study. Patients aged 70 years or older with histologically confirmed ESCC (stages IB to IVB according to the 6th edition of the American Joint Committee on Cancer) will be included. Patients will undergo radiotherapy with concurrent chemotherapy and immunotherapy. Follow-up evaluations will be conducted every 3 months until disease progression or up to 2 years.
Eligibility Criteria:
Inclusion Criteria:
Voluntary participation with written informed consent. Age ≥70 years, regardless of gender. Histologically or cytologically confirmed ESCC. Inoperable or refusal of surgery, with tolerance for anti-tumor treatment. ECOG performance status 0-2. Expected survival ≥6 months. No severe abnormalities in hematologic, cardiac, pulmonary, hepatic, or renal function, and no immunodeficiencies.
Exclusion Criteria:
Distant organ metastasis (excluding supraclavicular lymph nodes). Previous esophageal fistula, perforation, or pre-treatment for malignancy. Prior thoracic radiotherapy. Active autoimmune diseases or history of autoimmune diseases. Previous or ongoing PD-1 inhibitor treatment or participation in other interventional clinical studies.
Allergy to large protein formulations or components of S-1 capsules. Uncontrolled cardiac conditions. Immunodeficiencies (e.g., HIV infection), active hepatitis B or C, or active tuberculosis.
Active infection or unexplained fever >38.5°C within 2 weeks before screening. History of other malignancies within 5 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ).
Scientific and Social Value:
This study aims to explore effective treatment options for elderly ESCC patients and enhance the influence of the discipline in this field.
Recruitment and Informed Consent:
Participants will be recruited through physician referrals. Informed consent will be obtained from all participants, ensuring their privacy and confidentiality.
Outcome Measures:
Primary outcomes: ORR, OS, PFS, DCR, DoR, R0 resection rate, and AEs. Secondary outcomes: Identification of potential predictive biomarkers.
Study Duration:
The study will cover a period from January 2022 to March 2025, with follow-up evaluations conducted every 3 months until disease progression or up to 2 years.
Publication Plan:
The results of this study will be published in high-quality scientific journals.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of elderly patients (≥70 years) with histologically confirmed ESCC who are not suitable for surgery or refuse surgery but are able to tolerate anti-tumor treatment. The inclusion and exclusion criteria are designed to ensure the safety and efficacy of the study while maintaining a representative patient population for the research objectives.
Key inclusion criteria (1 listed)
- Voluntary participation with written informed consent. Age ≥70 years, regardless of gender. Histologically or cytologically confirmed ESCC. Inoperable or refusal of surgery, with tolerance for anti-tumor treatment. ECOG performance status 0-2. Expected survival ≥6 months. No severe abnormalities in hematologic, cardiac, pulmonary, hepatic, or renal function, and no immunodeficiencies.
Key exclusion criteria (4 listed)
- No severe abnormalities in hematologic, cardiac, pulmonary, hepatic, or renal function, and no immunodeficiencies.
- Distant organ metastasis (excluding supraclavicular lymph nodes). Previous esophageal fistula, perforation, or pre-treatment for malignancy. Prior thoracic radiotherapy. Active autoimmune diseases or history of autoimmune diseases. Previous or ongoing PD-1 inhibitor treatment or participation in other interventional clinical studies.
- Allergy to large protein formulations or components of S-1 capsules. Uncontrolled cardiac conditions. Immunodeficiencies (e.g., HIV infection), active hepatitis B or C, or active tuberculosis.
- Active infection or unexplained fever >38.5°C within 2 weeks before screening. History of other malignancies within 5 years (except cured basal cell carcinoma of the skin or cervical carcinoma in situ).
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 |
|---|---|---|
| Immunotherapy TherapyPatients will receive concurrent chemoradiotherapy (CCRT) combined with immunotherapy. The treatment includes: Radiotherapy: Individualized radiotherapy targeting the tumor. Concurrent Chemotherapy: Platinum-based doublet chemotherapy (e.g., cisplatin + fluorouracil or S-1) administered during radiotherapy. Immunotherapy: PD-1 inhibitor (e.g., tislelizumab) used to enhance the immune response against cancer cells. The treatment will be tailored to each patient's condition, with regular follow-up assessments every 3 months for up to 2 years to monitor efficacy and safety. | Drug | – |
Primary outcome
Objective Response Rate
Time frame: 3 months
Imaging assessments every 3 months after treatment initiation until disease progression or up to 2 years.
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 23 Jul 2025.
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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.
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 (ESCC), run by Three Gorges Hospital of Chongqing 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 1 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: looking for participants now, as of the sponsor's last update on 23 Jul 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?
Contact Han Zhang (86-15023366912, 4081548@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 3 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 23 Jul 2025.