Clinical trial NCT06787313: Precision Palliative Care for Patients with Advanced Esophageal Cancer
Official title: Precision Palliative Care for Patients with Advanced Esophageal Cancer: a Randomized Phase III Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Esophageal Cancer
Keywords: Precision palliative Care
immunotherapy
PD-1
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 PD-1 immunotherapy. Subjects are inpatients or outpatients.

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.


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 PD-1 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 PD-1 immunotherapy.
4. Allergic to macromolecular protein preparations, or to any of the ingredients in PD-1 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.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
measure: PFS
timeFrame: 2 years
measure: biomarker
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University
state: Shanghai
Study officials:
References: