Combining Adebrelimab with Chemoradiotherapy for Advanced Esophageal Cancer
A Phase II Clinical Study on the Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma
This study is testing if adding a new immunotherapy drug called adebrelimab to standard chemotherapy and radiation can help people with advanced esophageal cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone, adebutilimab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06885814 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of adebrelimab, an immunotherapy agent, when combined with chemoradiotherapy in patients suffering from unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma. The study involves a single-center, single-arm, open-label design, treating thirty patients with a specific regimen of intensity-modulated radiotherapy and chemotherapy. Patients will undergo imaging assessments before and after treatment to determine the response rates, including complete and partial responses. The trial aims to provide insights into the potential benefits of this combined treatment approach for a challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma confirmed by histology.
Not a fit: Patients with other malignant tumors diagnosed within the previous five years or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for patients with advanced esophageal cancer.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy and chemoradiotherapy combinations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-75 years old, gender unlimited 2. Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence 3. According to the solid tumor efficacy evaluation criteria (RECIST1.1), there is at least one measurable lesion; And the lesion had not received prior radiotherapy 4. ECOG: 0\~1 5. Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L, platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 times ULN, ALT and AST≤2.5 times ULN 7: Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up 8: Tissue samples should be provided for biomarker analysis such as (PD-L1). Newly acquired tissues are preferred, and 15 5-6um thick paraffin sections can not be provided for archiving by the recent organizer Exclusion Criteria: 1. Other malignant tumors have been diagnosed within the previous 5 years 2. There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded) 3. Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding 4. Have any history of active autoimmune disease or autoimmune disease 5. Have clinical symptoms or diseases of the heart that are not under control 6. Active infection or fever (except definite tumor fever) 7. History or evidence of interstitial lung disease or active non-infectious pneumonia 8. Patients with immune dysfunction and active hepatitis 9. Those who have previously received PD-1 or PD-L1 antibody therapy 10. Allergic to any drug in this protocol 11. Patients receiving immunosuppressive drugs or corticosteroids \>10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment 12. Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment 13. Pregnant or lactating women
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Wei Wang
- Email: 29262574@qq.com
- Phone: 86+18520529179
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.