Precision Palliative Care for Patients With Advanced Esophageal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: precision palliative care.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Precision Palliative Care for Patients With Advanced Esophageal Cancer: a Randomized Phase III Trial
Overview
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.
Interventions
- Other precision palliative care
Participants receive precision palliative care based on scale screening result.
Primary outcome measures
- Overall survival [Time frame: 2 years]
Secondary outcome measures (3)
- Quality of life [Time frame: 1 year]
- PFS [Time frame: 2 years]
- biomarker [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University — Shanghai
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: 10.1080/1 PMID 41778625
Identifiers
NCT: NCT06787313 · ESO-Shanghai25