NCT06190782 Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor
| NCT ID | NCT06190782 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 354 participants |
| Start Date | 2022-09-27 |
| Primary Completion | 2025-09-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 354 participants in total. It began in 2022-09-27 with a primary completion date of 2025-09-27.
⚠ 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
Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone. The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.
Eligibility Criteria
Inclusion Criteria: * 1\. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases Exclusion Criteria: * 1\. History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20\>25%
Contact & Investigator
Kuaile Zhao, MD
STUDY DIRECTOR
Fudan University
Frequently Asked Questions
Who can join the NCT06190782 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06190782 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 354 participants.
Is NCT06190782 currently recruiting?
Yes, NCT06190782 is actively recruiting participants. Contact the research team at 18017317882@163.com for enrollment information.
Where is the NCT06190782 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06190782 clinical trial?
NCT06190782 is sponsored by Fudan University. The principal investigator is Kuaile Zhao, MD at Fudan University. The trial plans to enroll 354 participants.