Clinical trial · Interventional
Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC
The Safety and Efficacy of Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC,A Single-arm Study
NCT05469061CI-TRIAL-00059802unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm,open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Locally Advanced Carcinoma | Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| cis Platinum | Drug | Cisplatin | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab plus Chemotherapy
- description
- In the single experimental arm, patients with locally nonresectable disease were subjected to receive neoadjuvant tislelizumab (200mg) plus chemotherapy (FP regimen) for conversion therapy. If conversion therapy succeeds, patients would proceed to surgery and adjuvant therapy. Otherwise, if patients were still not resectable after the conversion therapy, they will be treated by tislelizumab plus chemotherapy with or without palliative radiotherapy .
- interventionNames
- Drug: Tislelizumab
- Drug: 5-FU
- Drug: cis Platinum
Primary outcomes (3)
- measure
- Incidence of translational treatment AE
- timeFrame
- up to 2 years
- description
- Translational treatment-related AEs resulted in rates of surgery that were more than 30 days late or inoperable than originally planned
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged between 18 and 75 years; 2. Understand the research procedure and content, and voluntarily sign written informed consent; 3. Patients with clinical stage IIA-IIIB esophageal cancer were assessed by endoscopic ultrasonography, CT/MRI and other imaging. 4. Esophageal surgery experts believe that patients with potentially resectable esophageal cancer 5. No blood transfusion was received 3 months before enrollment; 6. ECOG PS score: 0-1. Exclusion Criteria: * Patients meeting any of the following criteria are not eligible for inclusion: 1. Women who are pregnant or breastfeeding; 2. previous or concurrent malignancy; 3. Participated in clinical trials of other drugs within four weeks; 4. Have a history of immune deficiency, or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation, or have a history of serious chronic autoimmune diseases, such as systemic lupus erythematosus, etc. 5. Patients with hypersensitivity to human or mouse monoclonal antibodies; 6. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 7. According to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.
References
Publications (1)
- DERIVEDXu T, Bai J, Zhao K, Chen X, Wang S, Zhu S, Sun C, Zhao C, Wang T, Zhu L, Hu M, Pang F, Zhang J, Wang W, Shu Y, Li F, Zhou Y. Induction Therapy of Tislelizumab Combined with Cisplatin and 5-Fluorouracil and Subsequent Conversion Surgery in Patients with Unresectable Advanced Esophageal Squamous Cell Carcinoma: A Phase 2, Single Center Study. Ann Surg Oncol. 2024 Dec;31(13):9321-9331. doi: 10.1245/s10434-024-16033-x. Epub 2024 Aug 23. PMID 39179863