Combining chemotherapy with Tislelizumab for esophageal cancer after surgery
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
This study is testing if combining an immunotherapy drug called Tislelizumab with chemotherapy can help people with esophageal cancer live longer after surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Affiliated Cancer Hospital of Shantou University Medical College Academic / other |
| Drugs / interventions | Tislelizumab, chemotherapy, immunotherapy, nivolumab |
| Locations | 1 site (Shantou, Guangdong) |
| Trial ID | NCT05984342 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining Tislelizumab, an immunotherapy drug, with chemotherapy as an adjuvant treatment for patients with lymph node-positive esophageal squamous cell carcinoma (ESCC) following radical surgery. The study aims to determine if this combination can improve overall survival rates in patients who have undergone surgery for ESCC. Participants will be randomly assigned to receive either the combination therapy or standard care, and their outcomes will be monitored to assess the efficacy of the treatment. The trial is particularly relevant given the poor prognosis associated with ESCC and the lack of optimal postoperative therapies currently available.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with untreated, histologically confirmed ESCC and positive lymph nodes who are undergoing radical esophagectomy.
Not a fit: Patients with previous malignancies, active autoimmune diseases, or those requiring immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with lymph node-positive ESCC after surgery.
How similar studies have performed: Previous studies, such as the CheckMate 577 trial, have shown success with similar immunotherapy approaches, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between 18 and 70 years 2. Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy) 3. Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （T1-3N1-3M0） 4. undergoing radical esophagectomy 5. ECOG (Eastern Cooperative Oncology Group) : 0-1 6. No recurrent disease before adjuvant therapy 7. Normal hemodynamic indices before the recruitment 8. Able to understand this study and have signed informed consent Exclusion Criteria: 1. previous or concurrent malignancy 2. Interstitial lung disease 3. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications 4. Known or suspected allergy to chemotherapeutic drugs or Tislelizumab 5. Active autoimmune disease 6. Active hepatitis 7. Those whom the investigator considered unsuitable for inclusion
Where this trial is running
Shantou, Guangdong
- Cancer Hospital of Shantou University Medical College — Shantou, Guangdong, 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.