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Trial Title:
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05495152
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Patients in adjuvant arm receive 17 cycles of Sintilimab within 4 to 12 weeks after
esophagectomy for ESCC. Sintilimab was administered intravenously at a dose of 200 mg
over 30 minutes every 3 weeks.
Arm group label:
Adjuvant Arm
Summary:
No adjuvant treatment has been established for patients who remain at high risk for
recurrence after neoadjuvant chemotherapy plus surgery and incidental pathologic lymph
node metastasis following initial surgery for esophageal squamous cell carcinoma
(ESCC).Controversy still exists regarding the role of adjuvant immunotherapy for ESCC
patients who do not achieve pCR after neoadjuvant chemotherapy plus surgery and clinical
T1-2 N0 patients with incidental pathologic lymph node metastasis following initial
surgery. To investigate the outcomes of adjuvant Sintilimab in patients with locally
advanced ESCC, we initiated this randomized controlled trial (RCT).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically proven squamous cell carcinoma.
2. Tumours are located in the thoracic oesophagus.
3. Age is between 18 years and 70 years.
4. ECOG performance status of 0 or 1.
5. Patients with resectable cT1-4aN+M0 or T3-4aN0M0 disease and residue disease is
found after neoadjuvant chemotherapy plus surgery or cT1-2N0M0 and pathologically
proven T1-2N+M0 after upfront surgery.
6. No metastatic cervical lymph nodes.
7. R0 resection is achieved by the minimally invasive esophagectomy (MIE) or open
McKeown approach with total two-field lymph nodes dissection or three-field lymph
nodes dissection.
8. No prior therapy was administered against other cancers.
9. Adequate bone marrow function: white blood cell count ≥ 4×109/L; absolute neutrophil
count (ANC) ≥ 1.5×109/l; platelets ≥ 100×109/L; haemoglobin ≥ 9 g/dl.
10. Adequate liver function: serum bilirubin ≤ 1.5 × upper limit of normal (ULN);
aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 × ULN (ULN as per
institutional standard).
11. Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using the
Cockcroft-Gault formula.
12. Normal thyroid function.
13. Written consent is obtained.
Exclusion Criteria:
1. Patients receive neoadjuvant chemoradiation therapy.
2. Patients with pathological complete response (pCR).
3. No. of lymph node dissection < 15.
4. Patients with clinical stages T1-2N+M0 and receive upfront surgery.
5. Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive
induction chemotherapy.
6. Patients requiring systemic steroid medication.
7. Patients with severe postoperative complications and not suitable for adjuvant
therapy.
8. Synchronous or metachronous (within 5 years) double cancers.
9. Patients ever received immunotherapy.
10. Active infection requiring systemic therapy.
11. Patients ever received organ transplant or allogenic haemopoietic stem cell
transplantation.
12. Patients with human immunodeficiency virus (HIV) infection.
13. Psychiatric disease.
14. Pregnant or lactating women or women of childbearing potential.
15. Hypersensitivity for Sintilimab.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Haibo Sun
Phone:
+8615188301091
Email:
sunny-haipo@hotmail.com
Contact backup:
Last name:
Haibo Sun
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Status:
Recruiting
Contact:
Last name:
Haibo Sun, MD
Phone:
15188301091
Email:
sunny-haipo@hotmail.com
Start date:
August 1, 2022
Completion date:
August 31, 2028
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05495152
