Precision Palliative Care for Patients With Advanced Esophageal Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Other: precision palliative care

• Study Type: Observational
• Enrollment (Estimated): 624

Contacts and Locations

• Study Contact: Name: Kuaile Zhao, PhD; Phone Number: +86 1364198009 +86 18017312534; Email: kuaile_z@sina.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University
      • Contact: Kuaile Zhao, PhD; Phone Number: +86 18017312534; Email: kuaile_z@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

1. Written informed consent
2. Aged ≥18 years
3. Histologically confirmed esophageal cancer
4. Clinical stages IV based on the 8th AJCC TNM classification, or recurrent esophageal cancer
5. plan to treated with anti-PD-1/PD-L1 immunotherapy
6. Eastern Cooperative Oncology Group(ECOG) performance status: 0-2
7. 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:

1. Esophageal perforation or hematemesis
2. 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).
3. Disease progression occurs within 3months after anti-PD-1/PD-L1 immunotherapy.
4. Allergic to macromolecular protein preparations, or to any of the ingredients in anti-PD-1/PD-L1 inhibitors for injection.
5. 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.
6. 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.

7. 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.

8. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard Arm; All participants receive standard oncologic palliative care.
Supportive Arm; All participants receive precision palliative care based on scale screening result.	Other: precision palliative care; Participants receive precision palliative care based on scale screening result.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival for all patients	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Quality of life for all patients	1 year
PFS	PFS for all patients	2 years
biomarker	biomarker to predict immunotherapy effect	2 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 18, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: immunotherapy; PD-1; Precision palliative Care
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ESO-Shanghai25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No