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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Radiotherapy
RadiationIMRT or SABR for patients with ESCC.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
OS from start of 1st line treatment in metastatic ESCC
Median OS and OS rate at 12 months and 24 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
Time frame
2 yearsSecondary outcomes
1
PFS from start of 1st line treatment in metastatic ESCC
Median PFS and PFS rate at 6 months, 12months and 18 months will be analysed based on Kaplan-Meier method and presented along with its 95% confidence interval.
Time frame
18 months2
Disease control rate
the ratio of patients with the best therapeutic evaluation is CR, PR and SD
Time frame
Evaluation at the end of radiotherapy and after every 2 months of systemic therapy.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov