Precision Palliative Care for Patients With Advanced Esophageal Cancer

NCT ID: NCT06787313

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 624 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2028-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard Arm

All participants receive standard oncologic palliative care.

No interventions assigned to this group

Supportive Arm

All participants receive precision palliative care based on scale screening result.

precision palliative care

Intervention Type: OTHER

Participants receive precision palliative care based on scale screening result.

Interventions

precision palliative care

Participants receive precision palliative care based on scale screening result.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Kuai Le Zhao, MD

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kuaile Zhao, PhD

Role: CONTACT

kuaile_z@sina.com

+86 18017312534 ext. +86 1364198009

Facility Contacts

Kuaile Zhao, PhD

Role: primary

kuaile_z@sina.com

+86 18017312534

Other Identifiers

ESO-Shanghai25

Identifier Type: -

Identifier Source: org_study_id