Clinical trial · Interventional
Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma
NCT05515315CI-TRIAL-00073763recruitingPhase 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)
To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunotherapy Esophagus Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin paclitaxel | Drug | — | UNRESOLVED |
| Nedaplatin | Drug | Nedaplatin | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab combined with chemothapy
- interventionNames
- Drug: Tislelizumab
- Drug: Albumin paclitaxel
- Drug: Nedaplatin
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- up to 24 months
- description
- Time from enrollment to the onset of disease progression or death
Secondary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- every 6 weeks (up to 24 months)
- description
- Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed localized ESCC that is suitable for cCRT, including: stage II-IVA (AJCC version 8) inoperable ESCC (medically unfit for surgery or refusing surgical intervention);; * Aged 18-70, both sexes; * ECOG score 0-1 * The presence of measurable and/or nonmeasurable lesions that met the definition of RECIST1.1; * Adequate organ and bone marrow function, meeting the following definitions: 1. Blood routine (no blood transfusion, no granulocyte colony-stimulating factor \[G-CSF\], and no other drugs were used within 14 days before treatment);Absolute neutrophil count (ANC) ≥1.5×109/L;Hemoglobin (HB) ≥9.0 g/dL;Platelet count (PLT) ≥100×109/L; 2. Blood biochemistry Creatinine clearance rate ≥60 mL/min;Total bilirubin (TBIL) ≤ 1.5×ULN;Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN; * Expected survival time \> 6 months; * Fertile female subjects and male subjects with partners of reproductive age are required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last treatment; * Patients who volunteered to participate in this study and signed the informed consent form. Exclusion Criteria: * A history of fistula caused by primary tumor invasion; * Presence of clinically uncontrolled pleural effusion, pericardial effusion, or ascites that required repeated drainage or medical intervention (within 2 weeks before randomization); * Known intolerance or resistance to chemotherapy specified in the trial protocol; * have received any other ESCC antitumor therapy (e.g., therapy targeting PD-1, PD-L1, PD-L2 or other tumor immunotherapy, radiotherapy, targeted therapy, ablation or other systemic or local antitumor therapy); * Patients with active autoimmune disease or a history of autoimmune disease that may relapse, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; * History of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases, including pulmonary fibrosis and acute lung disease; * Severe chronic or active infection (including tuberculosis infection) requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment; * Known history of HIV infection; * Other malignancies (except cured basal cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix) in the past 5 years; * Received live vaccine within 28 days before enrollment; * while participating in another therapeutic clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.