Precision Palliative Care for Patients With Advanced Esophageal Cancer

NCT06787313 | Recruiting DMC

• 1 other identifier: ESO-Shanghai25
• Study Type: observational
• Target: 624
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Precision palliative Care; immunotherapy; PD-1

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival for all patients

  2 years

Secondary Outcomes (3)

• Quality of life

  1 year

• PFS

  2 years

• biomarker

  2 years

Study Arms (2)

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

Interventions

precision palliative care OTHER

Participants receive precision palliative care based on scale screening result.

Supportive Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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 4:1-8. doi: 10.1080/14796694.2026.2637738. Online ahead of print.

  PMID: 41778625 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Kuaile Zhao, PhD

CONTACT

+86 18017312534; kuaile_z@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 22, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CN (1)