This study is a single center, prospective, single arm exploratory clinical trial aimed at evaluating the efficacy and safety of sequential chemoradiotherapy combined with cetuximab in unresectable locally advanced esophageal squamous cell carcinoma. Patients with advanced unresectable esophageal squamous cell carcinoma who meet the criteria, after signing the informed consent form, will first receive induction therapy with cetuximab combined with paclitaxel and carboplatin chemotherapy for 2 cycles. Within 3 weeks after the second dose, RECIST v1.1 will be used for clinical tumor imaging evaluation, and if necessary, gastroscopy biopsy will be performed. Patients without progression will further receive synchronous radiotherapy and chemotherapy. PTV-C accepts 50.4Gy, 28 times; Radiotherapy combined with paclitaxel and carboplatin weekly regimen. Within three months after completion, conduct safety assessments and preliminary evaluations of tumor response every three weeks. Consolidate treatment with cetuximab until 1 year or intolerance or disease progression occurs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Cadonilimab is a PD-1/CTLA-4 bispecific antibody. The drug is administered at a fixed dose of 10mg/kg, intravenously (i.v.), on day 1, every 3 weeks (q3w), until disease progression or intolerable toxicity occurs, with a maximum treatment duration of 1 year.
GTV is defined as visible lesions (GTVp: primary lesion; GTVn: metastatic lymph nodes), CTVp is defined as 3cm above and below the primary lesion, with 0.5cm outward expansion around the periphery, and CTVn is defined as 0.5cm outward expansion of GTVn; PTVp is an outward expansion of 0.5cm for CTVp, and PTVn is an outward expansion of 0.5cm for CTVn. Radiotherapy dose: DT50.4Gy/28f, once daily, 5 times a week
Induction chemotherapy: carboplatin 5AUC,q3w; Paclitaxel 135mg/m2,q3w. Simultaneous chemotherapy: 2AUC/W,total 5w; Paclitaxel 50mg/m2/w,total 5w
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
2-year progression free survival rate
Time frame: 2 year after the end of treatment
Incidence of Treatment-Emergent Adverse Events
The incidence of adverse events (AE) and serious adverse events (SAE) within three months after radiotherapy, and the incidence of treatment termination caused by AE/SAE
Time frame: Within three months after radiotherapy
Progression free survival (PFS)
Time frame: From the randomization date until the first recorded date of progression or death from any cause, whichever comes first, assessed up to 36 months
Overall survival (OS)
Time frame: From the randomization date until death from any cause,assessed up to 36 months
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