NCT05495152RecruitingPhase 3
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma
Adjuvant Sintilimab for Locally Advanced Esophageal Squamous Cell Carcinoma: a Multi-Centre, Open-Label, Randomized, Controlled, Clinical Trial (HCHTOG2203)
Source: ClinicalTrials.gov · Last updated 2 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 219 (estimated)
- First submitted
- 8 Aug 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 31 Aug 2025
- Lead sponsor
- Henan Cancer Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05495152
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 219
- From 1 Aug 2022 to the primary completion date, 31 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receive neoadjuvant chemoradiation therapy.
- Patients with clinical stages T1-2N+M0 and receive upfront surgery.
- Patients requiring systemic steroid medication.
- Patients with severe postoperative complications and not suitable for adjuvant therapy.
- Patients ever received immunotherapy.
- Patients ever received organ transplant or allogenic haemopoietic stem cell transplantation.
Other illness
- Patients with unresectable disease (bulky metastatic lymph nodes or T4b) and receive induction chemotherapy.
- Synchronous or metachronous (within 5 years) double cancers.
- Active infection requiring systemic therapy.
- Patients with human immunodeficiency virus (HIV) infection.
- Psychiatric disease.
- Hypersensitivity for Sintilimab.
Other
- Patients with pathological complete response (pCR).
- No. of lymph node dissection \< 15.
- Pregnant or lactating women or women of childbearing potential.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.