Clinical trial · Interventional
Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma
A Study on the Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
NCT07595770CI-TRIAL-00111961ANCRErecruitingPhase 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 study aims to systematically evaluate the safety and efficacy of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.
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 (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adebrelimab and nab-paclitaxel plus carboplatin followed by radiotherapy
- description
- Patients would receive Adebrelimab (IV 1200mg d1) and nab-paclitaxel (IV 220 mg/m²d1) plus carboplatin (AUC = 5, d1) for two 21-day cycles, followed by one week off for radiotherapy (2.5 ⨉12 Gy). After radiotherapy, another cycle of Adebrelimab (IV 1200mg d1) would be given. 4 to 6 weeks after completing the neoadjuvant therapy, patients would undergo esophagectomy.
- interventionNames
- Drug: • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy
Primary outcomes (1)
- measure
- Pathological complete response (pCR)
- timeFrame
- From patient enrollment to the end of surgery
- description
- The proportion of subjects with no residual viable tumor cells(ypT0N0) in the primary tumor and lymph nodes; that is, the proportion of patients who have achieved complete remission among PPS(Per-Protocol Set).
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * \- 1. Provided informed consent and sign the informed consent form; * 2\. Male or female, Aged 18-75 years (counted on the date of signing informed consent); * 3\. Pathological confirmed ESCC; * 4\. Patients assessed by thoracic oncologists as resectable without distant metastasis * 5\. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results; * 6\. Have at least one assessable lesion according to the RECIST V1.1 * 7\. ECOG-PS score: 0-1; * 8\. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery; * 9\. With a life expectancy of ≥ 6 weeks; * 10\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease; Exclusion Criteria: * 1\. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy * 2\. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons * 3\. Simultaneously developing tumors in other parts of the body * 4\. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and/or AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times) * 5\. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses\>10 mg/day or oral prednisone for more than 2 weeks * 6\. Severe allergy to immune preparations * 7\. Abnormal coagulation function: (PT\>16s, APTT\>53s, TT\>21s, Fib\<1.5 g/L), bleeding tendency or during thrombolytic or anticoagulant therapy * 8\. Pregnancy or lactation period * 9\. Other situations as judged by investigators not suitable for inclusion.;
References
Publications (0)
Data not yet available
No reference posted for this study.