Precision palliative care for people with advanced esophageal cancer
Precision Palliative Care for Patients With Advanced Esophageal Cancer: a Randomized Phase III Trial
This project will try precision palliative care versus standard palliative care to see if it helps adults with advanced or recurrent esophageal cancer who are starting anti–PD‑1/PD‑L1 immunotherapy live longer and feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 624 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06787313 on ClinicalTrials.gov |
What this trial studies
This observational comparison will follow adults with histologically confirmed stage IV or recurrent esophageal cancer who plan to receive anti–PD‑1/PD‑L1 immunotherapy. Participants will receive either precision palliative care tailored to individual needs or standard palliative care and will be followed for one year. Outcomes include survival and patient‑reported measures of symptoms and quality of life (MDASI, PHQ‑9, GAD‑7). The study is conducted at Fudan University in Shanghai and uses regular surveys to compare the two approaches.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed stage IV or recurrent esophageal cancer who plan anti–PD‑1/PD‑L1 immunotherapy, have ECOG performance status 0–2, and meet basic organ function criteria are ideal candidates.
Not a fit: Patients with active or a history of significant autoimmune disease, recent esophageal perforation or hematemesis, or who are not receiving immunotherapy or have poor performance status (>2) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, precision palliative care could extend survival time and improve symptom control and quality of life by tailoring supportive care to individual needs.
How similar studies have performed: Early integrated palliative care has shown quality‑of‑life and symptom benefits in other advanced cancers, but tailoring palliative care specifically around immunotherapy for esophageal cancer is a relatively novel approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Kuaile Zhao, PhD
- Email: kuaile_z@sina.com
- Phone: +86 18017312534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.