Combining Tislelizumab and S-1 for Esophageal Cancer Treatment
The Efficacy of Tislelizumab Combined With S-1 in Patients With Residual Primary Lesions and Node-Negative Esophageal Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy Followed by Curative Resection: A Phase II, Multicenter Trial
This study is testing a new combination of two drugs, Tislelizumab and S-1, to see if it can help patients with esophageal cancer who have had surgery and still have some cancer left.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone, tislelizumab, nalizumab, pabolizumab, nabriliumab, tirellizumab, radiation |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06354140 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of combining Tegafur (S-1) with Tislelizumab in patients who have undergone radical resection for esophageal squamous cell carcinoma and have residual disease without lymph node involvement. The study aims to improve treatment outcomes for patients who have received neoadjuvant immunotherapy and chemotherapy. By focusing on patients with ypT1-4N0M0 staging, the trial seeks to explore a novel therapeutic approach in a population that has limited treatment options post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with ypT1-4N0M0 esophageal squamous cell carcinoma who have undergone radical resection and received neoadjuvant immunotherapy and chemotherapy.
Not a fit: Patients with other malignancies within the past five years or those with contraindications to chemotherapy or immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance survival rates and quality of life for patients with esophageal squamous cell carcinoma.
How similar studies have performed: While the approach of combining immunotherapy with chemotherapy is gaining traction, this specific combination of Tislelizumab and Tegafur in this patient population is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-75 years old, gender is not limited; 2. Patients with esophageal squamous cell carcinoma with neoadjuvant immunotherapy combined with chemotherapy (radiotherapy was not planned during the study period); 3. Thoracic esophageal squamous cell carcinoma patients with residual pathologic primary site and lymph node positive (ypT1-4aN0M0) after surgery (8th UICC-TNM stage); 4. The operation was radical resection; 5. Physical status ECOG 0 \~ 1 score; 6. No local recurrence or distant metastasis was found in the examination before postoperative adjuvant treatment; 7. There were no contraindications of chemotherapy or immunotherapy in the evaluation of various organ functions; 8. Understand and sign the informed consent. Exclusion Criteria: 1. Had malignant tumors other than esophageal cancer within 5 years prior to admission (cured localized tumors were not excluded, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ, etc.); Prostate cancer patients who received hormone therapy and obtained DFS for more than 5 years were not excluded). 2. Prior history of interstitial lung disease, or pneumonia requiring steroid treatment when enrolled; 3. Receiving systemic steroid therapy (more than 10mg of prednisone per day or equivalent) or other immunosuppressant within 2 weeks prior to randomization; 4. People who have been severely allergic to chemotherapy drugs (fluorouracil) or any monoclonal antibody; 5. Patients with active autoimmune diseases; 6. Patients with active hepatitis 7. According to the judgment of the researcher, there are other circumstances that are not suitable for participation in this study.
Where this trial is running
Chongqing, Chongqing Municipality
- Army Medical Center of the People's Liberation Army — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wei Guo
- Email: gyguowei@hotmail.com
- Phone: +86 13527323568
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.