Status:
RECRUITING
Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This study is a prospective, open-label, single-arm, single-center clinical study, aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy + pegylated recomb...
Detailed Description
The patients selected for the study were those who were diagnosed with esophageal cancer for the first time. The recruited subjects should be: 1. Preoperatively, the main part of the tumor was locate...
Eligibility Criteria
Inclusion
- Voluntary signing of informed consent;
- Male or female, aged 18 years or above and 75 years or below;
- Patients diagnosed with esophageal squamous cell carcinoma by biopsy histopathological examination of the primary lesion; cervical metastasis was excluded by cervical B-ultrasound.
- 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.
- Patients have not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.;
- The ECOG performance status score is 0-1;
- 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
- Patients need to be able to complete the treatment and follow-up according to the research plan on schedule;
- Patients need to have sufficient tissue samples and agree to use their tissue samples and blood samples for research analysis;
- Pregnancy tests in women of childbearing age were negative and were willing to take effective contraceptive measures during the study.
Exclusion
- Patients who may have tracheoesophageal fistula or aortic esophageal fistula;
- Patients with severe malnutrition or in need of tube feeding;
- 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);
- 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;
- 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;
- 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;
- Patients with uncontrollable systemic diabetes;
- Patients with interstitial lung disease, non-infectious pneumonia or pulmonary fibrosis;
- Patients with previous motor nerve or sensory nerve toxicity symptoms greater than WHO grade 1;
- Patients who have received allogeneic organ or stem cell transplantation in the past;
- Patients allergic to the drugs or related components involved in this study;
- Patients currently participating in other clinical studies;
- 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;
- Patients with any serious or unstable medical conditions or mental illnesses;
- Patients with known active alcohol or drug abuse or dependence.
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 22 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06563869
Start Date
February 2 2024
End Date
November 22 2026
Last Update
August 21 2024
Active Locations (1)
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1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029