NCT06787313 Precision Palliative Care for Patients With Advanced Esophageal Cancer
| NCT ID | NCT06787313 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Esophageal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 624 participants |
| Start Date | 2024-12-31 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 624 participants in total. It began in 2024-12-31 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06787313 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06787313 currently recruiting?
Yes, NCT06787313 is actively recruiting participants. Contact the research team at kuaile_z@sina.com for enrollment information.
Where is the NCT06787313 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06787313 clinical trial?
NCT06787313 is sponsored by Fudan University. The trial plans to enroll 624 participants.
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