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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Arm | All participants receive standard oncologic palliative care. | ||
| Supportive Arm | All participants receive precision palliative care based on scale screening result. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| precision palliative care | Other | Participants receive precision palliative care based on scale screening result. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival for all patients | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Quality of life for all patients | 1 year |
| PFS | PFS for all patients | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuaile Zhao, PhD | Contact | +86 18017312534 | +86 1364198009 | kuaile_z@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41778625 | Derived | 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. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| biomarker | biomarker to predict immunotherapy effect | 2 years |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |