ESO-Shanghai 20: phase III clinical trial of anti-PD-1 therapy with local intervention for oligometastatic ESCC.
Guangmin Mao, Zhuocheng Xin, Qingsong Fan...
https://pubmed.ncbi.nlm.nih.gov/40734507Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06190782
Phase III Randomized-controlled Study of PD-1 Inhibitor Combined With Local Therapy in Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Led by Fudan University · Updated on 2024-05-02
354
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with oligometastatic esophageal squamous cell carcinoma, a type of cancer with limited distant metastases. The study compares the combination of PD-1 inhibitor with or without chemotherapy plus local therapies against PD-1 inhibitor with or without chemotherapy alone. This phase III randomized study aims to assess progression-free survival as the primary endpoint, with secondary goals including overall survival, side effects, and local tumor control. Participants are randomly assigned in a 2:1 ratio to one of two groups: one receives PD-1 inhibitor with or without chemotherapy combined with local treatments such as radiotherapy, surgery, or radiofrequency/microwave ablation, while the other group receives only systemic therapy with PD-1 inhibitor with or without chemotherapy. Various local therapy techniques are allowed and planned to target all suspected malignant lesions. During the study, participants will be monitored through regular assessments of cancer progression, survival, treatment side effects, and tumor control at specified time points. Researchers will collect data on acute and late side effects, and local control rates at 1 and 3 years. The study involves follow-up to measure outcomes over three years, providing insights into the benefits and risks of combining local therapies with systemic immunotherapy or chemo-immunotherapy.
CONDITIONS
Brief Title
Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- ECOG performance status of 0 or 1
- Diagnosed with esophageal squamous cell carcinoma
- ASTRO/ESTRO defined genuine oligometastatic disease with 4 or fewer distant metastases
- No more than 3 metastatic lesions within a single organ
- Each metastatic lesion is 5 cm or smaller in maximum diameter
- At least one metastasis confirmed by pathology
You will not qualify if you...
- History of widespread metastatic disease or induced oligometastatic disease as defined by ASTRO/ESTRO
- Presence of esophageal perforation or hemorrhage
- Disease progression after prior PD-1 inhibitor treatment
- Recurrence within previous treatment field
- Intolerance to chemotherapy or immunotherapy
- Lung V20 radiation exposure greater than 25%
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 3 years or until disease progression or discontinuation
Participants receive PD-1 inhibitor with or without chemotherapy. Some participants additionally receive local therapies such as radiotherapy, surgery, or ablation targeting all suspected malignant lesions.
Visits occur regularly during treatment to administer therapies and monitor side effects
Follow-up
Duration - Up to 3 years
After treatment, participants continue to be monitored for progression-free survival, overall survival, side effects, and local control of disease.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai cancer center
Shanghai, China
Actively Recruiting
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Research Team
Q
Qi Liu, MD
K
Kuaile Zhao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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