Combining immunotherapy and chemotherapy for advanced esophageal cancer
The Prospective Study of Sintilimab Combination With Chemotherapy Sequential Radiotherapy for Advanced Esophageal Squamous Cell Carcinoma
This study is testing a new treatment that combines immunotherapy and chemotherapy to see if it helps people with advanced esophageal cancer feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qingdao Central Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Qingdao, Shandong and 1 other locations) |
| Trial ID | NCT06138028 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a combination treatment involving immunotherapy with Sintilimab, chemotherapy using a TP regimen (cisplatin and docetaxel), and sequential radiotherapy for patients with advanced esophageal squamous cell carcinoma. The study focuses on treatment-naive patients diagnosed with Stage IV disease and aims to assess the response of measurable lesions to this innovative approach. The trial is designed as a single-arm, exploratory study to gather insights on the potential benefits of this combined treatment strategy.
Who should consider this trial
Good fit: Ideal candidates for this study are treatment-naive patients diagnosed with Stage IV esophageal squamous cell carcinoma who have a measurable lesion.
Not a fit: Patients with earlier stages of esophageal cancer or those who have received prior treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced esophageal cancer.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in various cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with Stage IV esophagus squamous cell carcinoma. 2. Expected survival time ≥3 months 3. Enrolled patients must have at least one measurable lesion conforming to the RECIST V1.1 definition. 4. Physical fitness ECOG score of 0 or 1 5. Organ function levels must meet the following requirements and meet the following standards: A) Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ≥90×10\^9/L, hemoglobin ≥90 g/L; B) Liver function: Total bilirubin TBIL≤1.5×ULN (total bilirubin ≤3×ULN in Subjects with Gilbert's syndrome, liver cancer or liver metastasis), AST and ALT ≤2.5×ULN in patients without liver metastasis, AST and ALT ≤5.0×ULN in patients with liver metastasis; C) Renal function: Creatinine (Cr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula); D) Urine routine / 24-hour protein quantification: qualitative urine protein ≤1+ (if qualitative urine protein ≥2+, 24 hours \< 1g can be included); E) Cardiac function: left ventricular ejection fraction ≥50%; F) Coagulation function: International standardized ratio (INR) ≤1.5×ULN, and activated partial thrombin time (APTT) ≤1.5×ULN; Exclusion Criteria: 1. Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes) 2. Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation；Interstitial lung disease, drug-induced pneumonia,requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction； 3. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia； 4. Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above； 5. Allergic reactions to test drugs for this application； 6. Pregnant or lactating women； Those whom the investigator considered unsuitable for inclusion。
Where this trial is running
Qingdao, Shandong and 1 other locations
- Qingdao Central Hospital, Qingdao Cancer Hospital — Qingdao, Shandong, China (Recruiting)
- Qingdao Central Hospital — Qingdao, Shandong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.