Omega-3 Fatty Acids With PD-1 Inhibitors in Advanced Esophageal Cancer
Recruiting
N/A
Interventional Study
Esophageal Neoplasms
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 142 (estimated)
- Sponsor
- Fudan University · Other
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About This Trial
This is a randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate whether adding omega-3 fatty acids improves outcomes in adult patients with recurrent or metastatic esophageal cancer receiving PD-1 inhibitor therapy.
The main questions are:
Compared with placebo, does omega-3 (EPA+DHA) increase the longitudinal change in skeletal muscle index (ΔSMI) over 6 mont…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Age ≥18 years; ECOG 0-2. Histologically confirmed recurrent/metastatic esophageal cancer (AJCC 8th; de novo stage IV or relapse after prior therapy).
PD-1 inhibitor naïve, or prior PD-1 stopped \>3 months with subsequent progression (not primary PD-1 resistance).
Adequate organ…
Contacts