SBRT Combined With AK104 to Treatment Relapsed or Metastatic ESCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First People's Hospital of Changzhou
About this trial
The entire treatment process is divided into two phases: Phase I SBRT combined with PD-1/CTLA-4 bispecific antibody (AK104) and Phase II AK104 single-agent maintenance therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. age ≥ 18 years. 2. patients enrolled must be eligible for PD-1 treatment-naïve patients with recurrent or metastatic advanced esophageal squamous carcinoma with definite measurable recurrent or metastatic lesions.
Disqualifiers
1. pregnant gestational or lactating women. 2. those with a history of other malignant diseases in the last 5 years. 3. persons with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder whose clinical severity, as judged by the investigator, may prevent signing an informed consent form or affect patient compliance with medication.
Trial design
Design model
Single group
Treatments tested in this trial
SBRT
Radiation24-50Gy/8-12.5Gy/3-4f
Cadonilimab
Drug10 mg/kg,q3w
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: SBRT combined with PD-1/CTLA-4 dual antibodyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
ORR
objective response rate
Time frame
Up to 3 yearsSecondary outcomes
1
PFS
progression-free surviva
Time frame
Up to 3 years2
OS
Overall survival
Time frame
Up to 3 years3
Treatment Related Severe Adverse Effects
Number of participants with treatment-related severe adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame
Up to 3 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: