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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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;
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. 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;