Using Sintilimab to treat advanced esophageal cancer after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Haibo Sun
• Email: sunny-haipo@hotmail.com
• Phone: 15188301091

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining sintilimab with chemotherapy for treating esophageal cancer before surgery

  This study is testing if giving a new immunotherapy along with chemotherapy before surgery can help people with esophageal cancer have better outcomes.

  Recruiting Phase 3 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06563869

• Combining Sintilimab with Chemotherapy for Esophageal Cancer Treatment

  This study is testing if combining a new drug called sintilimab with chemotherapy can help people with advanced esophageal cancer before surgery.

  Recruiting Phase 2 Fujian Cancer Hospital · Fuzhou, Fujian · NCT06463834

• Using sintilimab after surgery for esophageal cancer

  This study tests if a medication called sintilimab can help prevent cancer from coming back in people who have had surgery for esophageal cancer.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06190639

• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

  This observational study looks at how doctors outline the radiation area for locally advanced esophageal squamous cell cancer patients treated with radiotherapy and immunotherapy to see which approaches correlate with better outcomes.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07858630

• Tafolecimab with chemoimmunotherapy as neoadjuvant treatment for locally advanced colon cancer

  This study tests whether adding tafolecimab to a chemoimmunotherapy regimen helps shrink locally advanced colon cancer before surgery in adults who have pMMR/MSS tumors.

  Recruiting Phase 2 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Chongqing, Chongqing Municipality · NCT07840677

• Irreversible Electroporation Added to Targeted Therapy and Immunotherapy for Advanced HCC

  This study tests whether adding irreversible electroporation to lenvatinib and sintilimab can help patients with unresectable advanced hepatocellular carcinoma see bigger tumor shrinkage and become eligible for surgery.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China · NCT07832006

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.