Efficacy and Safety of Cadonilimab and Chemoradiotherapy in Unresectable Locally Advanced Esophag… (NCT06715501) | Clinical Trial Compass
By InvitationNot Applicable
Efficacy and Safety of Cadonilimab and Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
China20 participantsStarted 2024-12-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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✓. Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
✕. Suffering from grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥470ms), and grade ≥2 congestive heart failure (New York Heart Association \[NYHA\] classification);
✕. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases;
What they're measuring
1
2-year progression free survival rate
Timeframe: 2 year after the end of treatment
2
Incidence of Treatment-Emergent Adverse Events
Timeframe: Within three months after radiotherapy
Trial details
NCT IDNCT06715501
SponsorFirst Affiliated Hospital of Ningbo University
. Active or uncontrolled severe infections (grade ≥2 CTCAE infections);
✕. Liver cirrhosis, active hepatitis; active hepatitis (for hepatitis B: positive HBsAg and HBV DNA levels exceeding the upper limit of normal; for hepatitis C: positive HCV antibodies and HCV viral load exceeding the upper limit of normal);
✕. Active syphilis;
✕. Renal failure requiring hemodialysis or peritoneal dialysis;
✕. A history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;