Combining Tislelizumab with Chemotherapy for Unresectable Esophageal Cancer
A Prospective, Single-center, Single-arm Phase II Clinical Study of the Safety and Efficacy of Tislelizumab Combined With Chemotherapy in the Treatment of Unresectable Esophageal Squamous Cell Carcinoma
This study is testing if combining an immunotherapy drug called tislelizumab with chemotherapy can help people with advanced esophageal cancer shrink their tumors enough to consider surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone, tislelizumab |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT05449483 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of combining tislelizumab, an immunotherapy drug, with chemotherapy agents Paclitaxel and Cisplatin in patients with unresectable esophageal squamous cell carcinoma. The goal is to determine if this combination can reduce tumor size and make it possible for surgical resection. The study is a prospective, single-center, single-arm phase II trial focusing on patients who are not candidates for R0 resection due to advanced disease. Participants will undergo treatment and be monitored for changes in tumor status and overall health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed unresectable esophageal squamous cell carcinoma at stage T4a/N3.
Not a fit: Patients with resectable tumors or those with significant comorbidities that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could potentially convert unresectable tumors into resectable ones, improving surgical outcomes for patients.
How similar studies have performed: There is limited existing research on transformation therapy for esophageal squamous cell carcinoma, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed esophageal squamous cell carcinoma; 2. Unresectable cT4a/N3(stage ⅣA) (AJCC 8 TNM classification); 3. Have a performance status of 0 or 1 on the ECOG Performance Scale; 4. Age 18-75 years old, both men and women; 5. Be willing and able to provide written informed consent/assent for the trial; 6. Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation; 7. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the study medication's first dose. If the urine test is positive or cannot be confirmed as unfavorable, a serum pregnancy test will be required; 8. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly acquired is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor. Exclusion Criteria: 1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer; 2. Ineligibility or contraindication for esophagectomy; 3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs); 5. Has severe hypersensitivity and adverse events (≥Grade 3) to any PD-1/PD-L1 inhibitors.
Where this trial is running
Tianjin, Tianjin
- Hongjing Jiang — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Hongjing Jiang, MD，phD — Tianjin Medical University Cancer Institute and Hospital
- Study coordinator: Hongjing Jiang, MD，phD
- Email: jianghongjing@tmu.edu.cn
- Phone: 18622221069
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.