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RECRUITINGPhase 3INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable. 2. Patients must not have received any prior anticancer therapy. 3. More than 6 months of expected survival. 4. Age ranges from 18 to 70 years. 5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelet count at least 100.0×109/L, blood count (hemoglobin) at least 90g/L, and normal functions of liver and kidney. 6. WHO PS score 0-1 7. Signed willing to sign a consent form document on file. Who Should NOT Join This Trial: 1. Patients have received any prior anticancer therapy. 2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin. 3. Patients with concomitant hemorrhagic disease. 4. Patients who cannot tolerate surgery. 5. Pregnant or breast feeding. 6. Patients without willing to sign a consent form because of psychological, family, social or any other factors. 7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more. 8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer. 9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control. 10. 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. 11. Patients with history of autoimmune conditions (where your immune system attacks your own body)s, weakened immune system, or organ and allogeneic bone marrow transplantation. 12. Patients with history of interstitial lung disease or noninfectious pneumonia. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable. 2. Patients must not have received any prior anticancer therapy. 3. More than 6 months of expected survival. 4. Age ranges from 18 to 70 years. 5. 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. 6. WHO PS score 0-1 7. Signed informed consent document on file. Exclusion Criteria: 1. Patients have received any prior anticancer therapy. 2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin. 3. Patients with concomitant hemorrhagic disease. 4. Patients who cannot tolerate surgery. 5. Pregnant or breast feeding. 6. Patients without informed consent because of psychological, family, social or any other factors. 7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more. 8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer. 9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control. 10. 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. 11. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation. 12. Patients with history of interstitial lung disease or noninfectious pneumonia. 13. 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. 14. Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).

Treatments Being Tested

DRUG

Sintilimab

Sintilimab 200mg, IV (in the vein) on day 1 and day 22

RADIATION

Preoperative radiotherapy

External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.

DRUG

Paclitaxel

50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22

DRUG

Cisplatin

25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22

PROCEDURE

esophagectomy

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)

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China