PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
Phase III Multicenter Randomized Controlled Trial of PD-1 Inhibitor Combined With Preoperative Concurrent Chemoradiotherapy and Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (NEOCRTEC2101)
Sun Yat-sen University
422 participants
Nov 1, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria14
- 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.
- Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
- Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
- Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
- Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
- Patients with history of interstitial lung disease or noninfectious pneumonia.
- Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
- Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).
Interventions
Sintilimab 200mg, IV (in the vein) on day 1 and day 22
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05357846