Clinical trial · Interventional
Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma
NCT06303583CI-TRIAL-00074899CRISenrolling by invitationPhase 1 / Phase 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)
The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer
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 |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
| tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IO
- description
- chemoradiotherapy sequential tislelizumab
- interventionNames
- Drug: paclitaxel
- Drug: carboplatin
- Drug: tislelizumab
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- Complete pathological response rate
- timeFrame
- 1 year
Secondary outcomes (4)
- measure
- R0 resection rate
- timeFrame
- 1 year
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Ages 18-75. * Histology confirmed thoracic esophageal squamous cell carcinoma. * ECOG ps 0 to 1. * Resectable or potentially resectable T2-4aN0 or T1-4aN+ patients (AJCC/UICC Clinical Staging of Esophageal squamous cell Carcinoma, 8th edition (cTMN)). * Length of esophageal lesions \<8cm. * There were no surgical contraindications. * Neutrophil count ≥1.5\*109/L, platelet count ≥10.0\*109/L, hemochrome ≥9g/dL; Serum creatinine ≤1.5 times the upper limit of normal value; Bilirubin ≤1.5 times the upper limit of normal value, AST, ALT, AKP≤2.5 times the upper limit of normal value. * BMI acuity 18.5 kg/m2. * Informed notification and signed informed consent. Exclusion Criteria: * Cervical esophageal cancer (upper part of the lesion in the cervical esophagus). Multifocal esophageal carcinoma, lesion length \>8cm. * Trachea and aorta were invaded (Annex 5). * Hoarseness caused by the tumor. * Esophageal fistula. * Lymph node metastasis in the neck and periceliac artery (AJCC/UICC 8th edition esophageal/esophagogastric junction region lymph node division 1 and 20). * A history of active autoimmune disorders or syndromes requiring treatment with systemic steroids or immunosuppressants (except for vitiligo or cured childhood asthma/allergies who do not require any intervention in adulthood; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone). * She is on hormonal or immunosuppressive therapy. * He's had an organ transplant. * HIV infection, hepatitis C (hepatitis C antibody positive with HCV-RNA above the detection limit of the assay), chronic active hepatitis B (HBV DNA≥2×103IU/ml or \>1×104copies/mL). * Active tuberculosis, interstitial pneumonia, active infection, poorly controlled diabetes, symptomatic arrhythmia, symptomatic new dysfunction, myocardial infarction, active peptic ulcer, chronic active enteritis within 6 months; Affected during pregnancy or lactation. * Major surgery in the last three months. * Severe diabetes mellitus with poor drug control, symptomatic arrhythmia, symptomatic cardiac insufficiency, myocardial infarction within 6 months, chronic active enteritis, chronic nephritis. QTc acuity 470 ms. * He had a history of malignancy. Previously received chemotherapy, radiotherapy, targeted therapy, immunotherapy and other antitumor therapies. * Patients with allergic or contraindicated taxa. * Live vaccine is administered within 30 days before the first dose of immunotherapy. * Refusal or inability to sign up for ICF study. * The investigator decided that the patient was not suitable to participate.
References
Publications (0)
Data not yet available
No reference posted for this study.