Squamous Cell Esophageal Carcinoma, Esophageal Cancer, Oesophageal Cancer
Conditions
Brief 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.
Interventions
DRUGSintilimab
Sintilimab 200mg, IV (in the vein) on day 1 and day 22
RADIATIONPreoperative radiotherapy
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
DRUGPaclitaxel
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
DRUGCisplatin
25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
PROCEDUREesophagectomy
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.
Sponsors
Affiliated Cancer Hospital of Shantou University Medical College
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 ).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | At end of enrollment- up to 5 years in follow up | Overall survival will be calculated from the date of randomization and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | At end of enrollment- up to 5 years in follow up | Progression free survival is defined as the time from randomization until objective tumor progression or death. |
| Pathologic complete response rate | Two weeks after surgery | No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes |
| R0 resection rate | Two weeks after surgery | The percentage of patients who undergo complete resection |
| Incidence of perioperative complications | Ninety days after surgery | Incidence of complications |
| Perioperative mortality | Ninety after surgery | Incidence of death postoperatively |
Countries
China
Contacts
Primary ContactHONG YANG, M.D. Ph.D.
Outcome results
None listed