Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05495152
Collaborator
(none)
219
1
2
73
3

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
219 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma: A Multi-Centre, Open-Label, Randomized, Controlled, Clinical Trial (HCHTOG2203)
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Aug 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adjuvant Arm

Patients in arm A 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.

Drug: Sintilimab
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.

No Intervention: Observation Arm

Patients in observation arm receive routine follow-up after surgery.

Outcome Measures

Primary Outcome Measures

  1. Disease-free Survival (DFS) [DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death , assessed up to 36 months]

    DFS is defined as the time from the date of randomization to the date of first recurrence (local, regional or distant) or death.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henan Cancer Hospital Zhengzhou Henan China 450008

Sponsors and Collaborators

  • Henan Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Haibo Sun, Vice Chief, Department of Thoracic Surgery, Henan Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05495152
Other Study ID Numbers:
  • HCHTOG2203
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022