Esophageal CancerNCT06787313
Precision Palliative Care for Patients With Advanced Esophageal Cancer
An observational study of Esophageal Cancer, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if precision palliative care improves survival of patients with advanced esophageal cancer in adults. Researchers will compare precision palliative care and standard palliative care to see if precision palliative care works more effectively to treat advanced esophageal s… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- precision palliative care
- How many people
- 624 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: in this study, all subjects are diagnosed with stages IV esophageal cancer or recurrent esophageal cancer. All subjects plan to treated with anti-PD-1/PD-L1 immunotherapy. Subjects are inpatients or outpatients.
Who may be able to join
- Written informed consent
- Aged ≥18 years
- Histologically confirmed esophageal cancer
- Clinical stages IV based on the 8th AJCC TNM classification, or recurrent esophageal cancer
- plan to treated with anti-PD-1/PD-L1 immunotherapy
- Eastern Cooperative Oncology Group(ECOG) performance status: 0-2
- Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN.
Who cannot join
- Esophageal perforation or hematemesis
- Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
- Disease progression occurs within 3months after anti-PD-1/PD-L1 immunotherapy.
- Allergic to macromolecular protein preparations, or to any of the ingredients in anti-PD-1/PD-L1 inhibitors for injection.
- Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
- Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
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- Active infection or unexplained fever >38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
- Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
- According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial 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, 1 recruiting
- Recruiting
Fudan University
Shanghai, Shanghai Municipality, 200032
Kuaile Zhao, PhD, +86 18017312534, kuaile_z@sina.com
About this study
Official title: Precision Palliative Care for Patients With Advanced Esophageal Cancer: a Randomized Phase III Trial
The goal of this clinical trial is to learn if precision palliative care improves survival of patients with advanced esophageal cancer in adults.
Researchers will compare precision palliative care and standard palliative care to see if precision palliative care works more effectively to treat advanced esophageal s cancer.
Participants will receive precision palliative care or standard palliative care. All participants will answer survey questions about their quality of life, MDASI, PHQ-9, GAD-7 for 1 years.
- Conditions
- Esophageal Cancer
- Being tested
- precision palliative care
- Keywords
- Precision palliative Care, immunotherapy, PD-1
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
precision palliative careOther
Participants receive precision palliative care based on scale screening result.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | All participants receive standard oncologic palliative care. | |
| Supportive Arm | All participants receive precision palliative care based on scale screening result. Receives: Other: precision palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival for all patients
Measured: 2 years
Secondary outcomes (3)
Quality of life
Quality of life for all patients
Measured: 1 year
PFS
PFS for all patients
Measured: 2 years
biomarker
biomarker to predict immunotherapy effect
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start31 Dec 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 624 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kuai Le Zhao, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787313
- Sponsor's protocol ID
- ESO-Shanghai25
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hao S, Wang X, Ding H, Chen Y, Liu Q, Zhang J, Fan X, Wu Z, Lin Y, Xu X, Mao G, Ai D, Deng J, Zhu H, Ye J, Mo M, Hu Z, Wang H, Cheng W, Feng W, Ling Y, Xu Y, Du S, Wang J, Zhao K. Precision palliative care in advanced/recurrent esophageal cancer patients treated with anti-PD-1/PD-L1 immunotherapy (ESO-Shanghai 25): a randomized, phase III Trial. Future Oncol. 2026 Mar;22(7):773-780. doi: 10.1080/14796694.2026.2637738. Epub 2026 Mar 4.
PubMed 41778625
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Palliative Care for Patients With Advanced Esophageal Cancer: a Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT06787313
- Acronym / sponsor ID
- ESO-Shanghai25
- Conditions
- Esophageal Cancer
- Keywords
- Precision palliative Care, immunotherapy, PD-1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jan 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.
The goal of this clinical trial is to learn if precision palliative care improves survival of patients with advanced esophageal cancer in adults.
Researchers will compare precision palliative care and standard palliative care to see if precision palliative care works more effectively to treat advanced esophageal s cancer.
Participants will receive precision palliative care or standard palliative care. All participants will answer survey questions about their quality of life, MDASI, PHQ-9, GAD-7 for 1 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | – | –All participants receive standard oncologic palliative care. |
| Supportive Arm | – | Other: precision palliative careAll participants receive precision palliative care based on scale screening result. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- in this study, all subjects are diagnosed with stages IV esophageal cancer or recurrent esophageal cancer. All subjects plan to treated with anti-PD-1/PD-L1 immunotherapy. Subjects are inpatients or outpatients.
Key inclusion criteria (7 listed)
- Written informed consent
- Aged ≥18 years
- Histologically confirmed esophageal cancer
- Clinical stages IV based on the 8th AJCC TNM classification, or recurrent esophageal cancer
- plan to treated with anti-PD-1/PD-L1 immunotherapy
Key exclusion criteria (9 listed)
- Esophageal perforation or hematemesis
- Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
- Disease progression occurs within 3months after anti-PD-1/PD-L1 immunotherapy.
- Allergic to macromolecular protein preparations, or to any of the ingredients in anti-PD-1/PD-L1 inhibitors for injection.
- Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
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 |
|---|---|---|
| precision palliative careParticipants receive precision palliative care based on scale screening result. | Other | Supportive Arm |
Primary outcome
Overall survival
Time frame: 2 years
Overall survival for all patients
3 secondary outcomes
Quality of life
Time frame: 1 year
PFS
Time frame: 2 years
biomarker
Time frame: 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 13 Jan 2026.
- Derived from this study: PubMed 41778625Hao S, Wang X, Ding H, Chen Y, Liu Q, Zhang J, Fan X, Wu Z, Lin Y, Xu X, Mao G, Ai D, Deng J, Zhu H, Ye J, Mo M, Hu Z, Wang H, Cheng W, Feng W, Ling Y, Xu Y, Du S, Wang J, Zhao K. Precision palliative care in advanced/recurrent esophageal cancer patients treated with anti-PD-1/PD-L1 immunotherapy (ESO-Shanghai 25): a randomized, phase III Trial. Future Oncol. 2026 Mar;22(7):773-780. doi: 10.1080/14796694.2026.2637738. Epub 2026 Mar 4.
- Individual participant dataSharing planned: Undecided
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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 Cancer, run by Fudan 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 7 inclusion and 9 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 13 Jan 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?
Contact Kuaile Zhao, PhD (+86 18017312534 ext. +86 1364198009, kuaile_z@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years). 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 NCT06787313, which also lists 1 linked publication.
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 13 Jan 2026.