Combining sintilimab with chemotherapy for treating esophageal cancer before surgery

Efficacy and Safety of Sintilimab in Combination With Platinum-containing Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Open, Single-arm, Single-center Clinical Study

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

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone, sintilimab
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06563869 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of sintilimab, a type of immunotherapy, combined with platinum-based chemotherapy and pegylated recombinant human granulocyte stimulating factor (PEG-rhG-GSF) as a neoadjuvant treatment for patients with resectable esophageal squamous cell carcinoma. Participants will receive two cycles of this treatment before undergoing surgery, with follow-up assessments to monitor outcomes. The study aims to determine the best approach to enhance surgical success and patient recovery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed, potentially resectable esophageal squamous cell carcinoma located in the middle or lower esophagus.

Not a fit: Patients who have previously received any form of anti-tumor treatment or have cervical metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival rates for patients with esophageal squamous cell carcinoma.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy and chemotherapy combinations in treating various cancers, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Voluntary signing of informed consent;
2. Male or female, aged 18 years or above and 75 years or below;
3. Patients diagnosed with esophageal squamous cell carcinoma by biopsy histopathological examination of the primary lesion; cervical metastasis was excluded by cervical B-ultrasound.
4. Patients who were judged by imaging and endoscopic ultrasound examination to have potentially surgically resectable middle and lower esophagus (below 18 cm from the incisors) and require neoadjuvant therapy (T2-4aNxM0, stage II-IVA); for T2N0M0, the length of the primary tumor under endoscopic examination was required to be ≥ 2 cm, located below the neck, and ≥ 5 cm away from the cricopharyngeal muscle.
5. Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.;
6. The ECOG performance status score is 0-1;
7. Have adequate heart, lung, liver and kidney functions, and the laboratory tests within 14 days before screening meet the following indicators:

   i. Hemoglobin HB ≥ 90 g/L ii. Absolute neutrophil count ANC ≥ 1.5 × 109 /L iii. Platelet count PLT ≥ 80 × 109 /L iv. Albumin ALB ≥ 35 g/L v. Alanine aminotransferase ALT and aspartate aminotransferase AST ≤ 1.5 times the upper limit of the normal range vi. Total bilirubin ≤ 30 μmol/L vii. Creatinine SCr ≤ the upper limit of the normal range. viii. Coagulation: PT-INR ≤ 2.3 or PT \< 6 seconds compared with the normal control
8. Patients need to be able to complete the treatment and follow-up according to the research plan on schedule;
9. Patients need to have sufficient tissue samples and agree to use their tissue samples and blood samples for research analysis;
10. Pregnancy tests in women of childbearing age were negative and were willing to take effective contraceptive measures during the study.

Exclusion Criteria:

1. Patients who may have tracheoesophageal fistula or aortic esophageal fistula;
2. Patients with severe malnutrition or in need of tube feeding;
3. Patients with other malignant tumors within 2 years and not cured (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ);
4. Patients with active autoimmune system diseases, or with a history of autoimmune system diseases or symptoms and in need of systemic hormone therapy or anti-autoimmune drug therapy;
5. Patients with immunodeficiency, or still receiving systemic steroid hormone therapy (prednisone \> 10 mg/day or other equivalent drugs) 7 days before the administration of the first dose of neoadjuvant therapy in this study, or other forms of immunosuppressive therapy;
6. Patients with active infection and still in need of systemic treatment 7 days before the administration of the first dose of neoadjuvant therapy in this study;
7. Patients with uncontrollable systemic diabetes;
8. Patients with interstitial lung disease, non-infectious pneumonia or pulmonary fibrosis;
9. Patients with previous motor nerve or sensory nerve toxicity symptoms greater than WHO grade 1;
10. Patients who have received allogeneic organ or stem cell transplantation in the past;
11. Patients allergic to the drugs or related components involved in this study;
12. Patients currently participating in other clinical studies;
13. Patients who received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibodies, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibodies or other immune or molecular targeted therapies within 4 weeks before screening;
14. Patients with any serious or unstable medical conditions or mental illnesses;
15. Patients with known active alcohol or drug abuse or dependence.

Where this trial is running

Nanjing, Jiangsu

• the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Yanhong Gu, Ph.D.

Conditions Esophageal Squamous Cell Carcinoma; esophageal squamous cell carcinoma, PEG-rhG-GSF