PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC… (NCT05357846) | Clinical Trial Compass
RecruitingPhase 3
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
China422 participantsStarted 2022-11-01
Plain-language summary
The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
✓. Patients must not have received any prior anticancer therapy.
✓. More than 6 months of expected survival.
✓. Age ranges from 18 to 70 years.
✓. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
✓. WHO PS score 0-1
✓. Signed informed consent document on file.
Exclusion criteria
✕. Patients have received any prior anticancer therapy.
✕. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
✕. Patients with concomitant hemorrhagic disease.
✕. Patients who cannot tolerate surgery.
✕. Pregnant or breast feeding.
✕. Patients without informed consent because of psychological, family, social or any other factors.
✕. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
What they're measuring
1
Overall survival
Timeframe: At end of enrollment- up to 5 years in follow up
✕. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.