A Study of IO Plus Radiotherapy in Patients With Advanced ESCC.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFudan University
About this trial
This study is a single-arm, prospective, phase II trial for patients with metastatic esophageal squamous cell carcinoma (ESCC) who received immunotherapy plus chemotherapy as the first-line treatment. The aim of the study is to determine if intervening with combined local therapy and immunotherapy and chemotherapy in patients with ESCC led to significant improvements in survival and disease control compared with historical data.
Eligibility criteria
Qualifiers
Age 18-80, had an Eastern Cooperative Oncology Group performance status score of 0-1;
Patients had unresectable or recurrent esophageal squamous cell carcinoma that precluded esophagectomy or definitive chemoradiation, or distant metastatic disease;
Patients had received no previous systemic therapy (patients who had progressed ≥6 months after [neo]adjuvant therapy or definitive chemoradiation were eligible);
Patients accepted at least one cycle of anti-PD-1 immunotherapy combined chemotherapy as 1st line treatment.
Disqualifiers
Patients who are prior exposure to immune-mediated therapy.
Patients participated in any investigational drug study within 4 weeks preceding the start of treatment.
The toxicity of previous anti-tumor treatment has not recovered to ≤ National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 level 1 (except for hair loss) or the level specified by the inclusion/exclusion criteria.
Patients with uncontrolled brain metastases, or vertebral body metastasis with spinal cord compression symptoms.
Trial design
Treatments tested in this trial
- Radiotherapy
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov