Combination of Cadonilimab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-006) (NCT06143748) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Combination of Cadonilimab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-006)
China46 participantsStarted 2024-03-02
Plain-language summary
Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer. However, as high as more than 40% of patients with esophageal cancer experienced locoregional recurrence after definitive CRT. Immune checkpoint inhibitors targeting PD-1/PD-L1 and/or CTLA-4 have shown substantial clinical benefits in advanced esophageal cancer. Recently, the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in esophageal cancer. The aim of this study was to evaluate the efficacy and safety of cadonilimab (a bispecific PD-1/CTLA-4 antibody) combined with induction chemotherapy followed by definitive radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed squamous cell carcinoma of the esophagus;
✓. Locally advanced, and absence of distant metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan, stage II-IVA (according to UICC TNM version 8);
✓. Not suitable for surgery (either for medical reasons or patient's choice);
✓. Age at diagnosis 18 to 75 years;
✓. No prior cancer therapy;
✓. Estimated life expectancy \>6 months;
✓. Eastern Cooperative Oncology Group performance status ≤ 2
✓. No history of concomitant or previous malignancy;
Exclusion criteria
✕. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
✕. Patients with distant metastasis disease or esophageal fistula at diagnosis;
What they're measuring
1
Progression-free survival
Timeframe: From date of enrollment until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 36 months.
✕. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of cadonilimab, and the chemotherapeutic drugs paclitaxel or cisplatin;
✕. Patients who have a preexisting or coexisting bleeding disorder;
✕. Female patients who are pregnant or lactating;
✕. Inability to provide informed consent due to psychological, familial, social and other factors;
✕. Presence of CTC grade ≥2 peripheral neuropathy;
✕. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer