Phase 2: testing • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy for Esophageal Squamous Cell Carcinoma (ESCC)
This study aims to systematically measure the safety and how well it works of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.
Official registry: https://clinicaltrials.gov/study/NCT07595770 · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · enrollment listed as 37
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy. The registry lists allocation as na. This study aims to systematically measure the safety and how well it works of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.
They plan to enroll about 37 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Study on the Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma
Interventions: • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy
Primary outcome (registry wording): Pathological complete response (pCR)
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- 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;
Who the registry excludes
- 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
Public study contact (from the registry)
Baisheng Chen, M.D, PhD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (recruiting)
FAQ about this NCT record
Is NCT07595770 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07595770?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07595770?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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