Adebrelimab with or Without Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Phase 2 Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the efficacy and safety of adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Aged 18-70 years, male or female;
• Have not received systemic or localized treatment in the past;
• Histologically or cytologically confirmed esophageal squamous cell carcinoma (AJCC 8th edition clinical stage II-IVA). IVB stage thoracic esophageal cancer with supraclavicular lymph node metastasis only. No surgical resection or refusal of surgical resection;
• ECOG score of 0-1;
• Life expectancy ≥ 3 months;
• Adequate organ function;
• Fertile men and women must agree to use contraception during the study period and for six months after the last drug used in the study；
• Subjects will voluntarily enroll in the study, sign an informed consent form, be compliant, and cooperate with follow-up visits.
Participants with CPS score ≥10 were enrolled.~Induction therapy: adebrelimab 1200mg iv d1 q3w x 2 cycles for 6 weeks.~Concurrent chemoradiotherapy: carboplatin AUC=2 / cisplatin 25mg/m2 d1 qw + paclitaxel 50mg/m2 / nab-paclitaxel 60mg/m2 d1 qw for a total of 5 weeks; radiotherapy:50Gy/25f, completed in 5 weeks.