Using Sintilimab to treat advanced esophageal cancer after surgery

Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma: a Multi-Centre, Open-Label, Randomized, Controlled, Clinical Trial (HCHTOG2203)

This study is testing if the immunotherapy drug Sintilimab can help people with advanced esophageal cancer who are at high risk of their cancer coming back after surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: Sintilimab, chemotherapy, immunotherapy
• Locations: 2 sites (Zhengzhou, Henan and 1 other locations)
• Trial ID: NCT05495152 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Sintilimab, an immunotherapy drug, as an adjuvant treatment for patients with locally advanced esophageal squamous cell carcinoma (ESCC) who are at high risk for recurrence after undergoing neoadjuvant chemotherapy and surgery. The study aims to determine whether this treatment can improve outcomes for patients who do not achieve a complete pathological response or have incidental lymph node metastasis. It is a randomized controlled trial designed to provide robust evidence on the role of immunotherapy in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 70 with histologically confirmed locally advanced ESCC who have undergone surgery and have residual disease or specific lymph node involvement.

Not a fit: Patients with metastatic cervical lymph nodes or those who have received prior cancer therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of cancer recurrence in patients with advanced esophageal cancer.

How similar studies have performed: While the role of adjuvant immunotherapy in ESCC is still debated, there have been promising results in similar studies exploring immunotherapy for other cancers.

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.

Where this trial is running

Zhengzhou, Henan and 1 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Haibo Sun

Conditions Esophageal Squamous Cell Carcinoma