Prospective Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With PD-1/PD-L1 Inh… (NCT06888531) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Prospective Phase II Clinical Study of Neoadjuvant Chemoradiotherapy Combined With PD-1/PD-L1 Inhibitors in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
China30 participantsStarted 2025-03-08
Plain-language summary
A prospective trial design was used to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1/PD-L1 inhibitors in the treatment of locally advanced resectable esophageal squamous cell carcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. At least one measurable lesion (according to RECIST 1.1 criteria).
✓. Normal major organ function
Exclusion criteria
✕. Allergic to the treatment drugs
✕. Patients who have received or are currently receiving other chemotherapy, radiotherapy, immunotherapy or targeted therapy
✕. Patients with tumors that have invaded major blood vessels as shown by imaging or those judged by the investigator to be highly likely to invade major blood vessels and cause fatal hemorrhage during the subsequent study period
✕. Patients with other malignant tumors that require active treatment within 5 years of the study (except for those that have been adequately treated, such as basal cell or squamous cell skin cancer with an expected 5-year survival rate \> 90%, cervical carcinoma in situ, and ductal carcinoma in situ of the breast)
✕. Patients with active autoimmune diseases or immunodeficiency
✕
What they're measuring
1
Pathologic complete response
Timeframe: From enrollment to the end of treatment at 2 years
. Patients who are currently using immunosuppressants or systemic hormones for immunosuppression purposes (dose \> 10mg/day of prednisone or other equivalent efficacy hormones) and have continued to use them within 2 weeks before enrollment
✕. Patients who have received systemic treatment with high-dose antibiotics within the past 2 weeks
✕. Patients who have experienced arterial or venous thrombotic events within 6 months before the first administration, including cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis and pulmonary embolism