Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT05495152 | Recruiting Phase 3

• 1 other identifier: HCHTOG2203
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 2

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).

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

Adjuvant Arm

EXPERIMENTAL

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

Observation Arm

NO INTERVENTION

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

Interventions

Sintilimab DRUG

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.

Adjuvant Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven squamous cell carcinoma.
• Tumours are located in the thoracic oesophagus.
• Age is between 18 years and 70 years.
• ECOG performance status of 0 or 1.
• 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.
• No metastatic cervical lymph nodes.
• 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.
• No prior therapy was administered against other cancers.
• 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.
• 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).
• Adequate renal function: glomerular filtration rate ≥ 60 ml/min calculated using the Cockcroft-Gault formula.
• Normal thyroid function.
• Written consent is obtained.

You may not qualify if:

• Patients receive neoadjuvant chemoradiation therapy.
• Patients with pathological complete response (pCR).
• No. of lymph node dissection \< 15.
• Patients with clinical stages T1-2N+M0 and receive upfront surgery.
• Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy.
• Patients requiring systemic steroid medication.
• Patients with severe postoperative complications and not suitable for adjuvant therapy.
• Synchronous or metachronous (within 5 years) double cancers.
• Patients ever received immunotherapy.
• Active infection requiring systemic therapy.
• Patients ever received organ transplant or allogenic haemopoietic stem cell transplantation.
• Patients with human immunodeficiency virus (HIV) infection.
• Psychiatric disease.
• Pregnant or lactating women or women of childbearing potential.
• Hypersensitivity for Sintilimab.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (2)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Related Publications (2)

• Al-Batran SE, Koch C. Neoadjuvant therapy for oesophageal cancer: refining the armamentarium. Lancet. 2024 Jul 6;404(10447):5-7. doi: 10.1016/S0140-6736(24)01084-5. Epub 2024 Jun 11. No abstract available.

  PMID: 38876135 DERIVED

• Sun HB, Xing WQ, Liu XB, Yang SJ, Chen PN, Liu SL, Li P, Ma YX, Jiang D, Yan S. A multicenter randomized, controlled clinical trial of adjuvant sintilimab for esophageal squamous cell carcinoma. Future Oncol. 2023 Aug;19(26):1777-1784. doi: 10.2217/fon-2022-1255. Epub 2023 Sep 22.

  PMID: 37737025 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Haibo Sun

CONTACT

15188301091; sunny-haipo@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chief, Department of Thoracic Surgery

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)