NCT06885814 Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma
| NCT ID | NCT06885814 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-06-06 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study was a single-center, single-arm, open-label phase II clinical trial. Thirty patients with unresectable locally advanced or postoperative recurrent esophageal squamous cell carcinoma were treated with concurrent chemoradiotherapy combined with immunotherapy. The radiotherapy regimen was intensity-modulated radiotherapy with PGTV at 50-50.4 Gy/25-28 fractions, 1.8-2 Gy per fraction, five times a week. The chemotherapy regimen was paclitaxel 50 mg/m2 and cisplatin 25 mg/m2 intravenous infusion on day 1, once a week for five times. The immunotherapy was with adebutilimab at 20 mg/kg on day 1, every three weeks for three times. One week before radiotherapy, gastroscopy, chest CT or PET-CT images were taken as the baseline standard. Based on the results of gastroscopy, chest CT or PET-CT before and after treatment, the number of patients with complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) in the two groups was observed. The objective response rate (ORR) was calculated as CR + PR, and the disease control rate (DCR) was calculated as CR + PR + SD. The progression-free survival (PFS), overall survival (OS), 1-year and 2-year survival rates and adverse reactions were also statistically analyzed.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06885814 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06885814 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06885814 currently recruiting?
Yes, NCT06885814 is actively recruiting participants. Contact the research team at 29262574@qq.com for enrollment information.
Where is the NCT06885814 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06885814 clinical trial?
NCT06885814 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 30 participants.