PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC
Squamous Cell Esophageal Carcinoma, Esophageal Cancer, Oesophageal Cancer
About this trial
This is an interventional treatment trial for Squamous Cell Esophageal Carcinoma
Eligibility Criteria
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.
- 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 ).
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
NCRT+IO group
NCRT group
• NCRT+IO group consists of the PD-1 inhibitor combined with concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks.PD-1 inhibitor is given by intravenous infusion on days 1 and 22. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions: Radiation: (40 or 45 Gy/20 fractions) Drug: Sintilimab Drug: Paclitaxel Drug: Cisplatin
• NCRT group consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions: Radiation: (40 or 45 Gy/20 fractions) Drug: Paclitaxel Drug: Cisplatin