NCT06885814Active, not recruitingPhase 2

Efficacy and Safety of Adebrelimab Combined With Chemoradiotherapy in Patients With Unresectable Locally Advanced or Postoperative Recurrent Esophageal Squamous Cell Carcinoma

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

Source: ClinicalTrials.gov · Last updated 2 Oct 2026

Brief summary (registry, in English)

This study was a multi-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 1200 mg 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.

Status (registry): Active, not recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 30 (estimated)
First submitted: 2 Mar 2025
Start date: 6 Jun 2024
Primary completion date: 1 Nov 2026
Lead sponsor: Nanfang Hospital, Southern Medical University
Diseases: Gastric and esophageal cancer
NCT number: NCT06885814

What you commit to

Study type: Interventional · Phase 2
Planned participants: 30
From 6 Jun 2024 to the primary completion date, 1 Nov 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Other malignant tumors have been diagnosed within the previous 5 years
Those who have previously received PD-1 or PD-L1 antibody therapy
Patients receiving immunosuppressive drugs or corticosteroids \>10mg/ day of prednisone therapeutic dose within 14 days prior to enrollment
Patients who had received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment

Other illness

Lesions invading the trachea or large blood vessels, or investigators judge that there is a high risk of esophageal/tracheal fistula or bleeding
Have any history of active autoimmune disease or autoimmune disease
Have clinical symptoms or diseases of the heart that are not under control
Active infection or fever (except definite tumor fever)
History or evidence of interstitial lung disease or active non-infectious pneumonia
Patients with immune dysfunction and active hepatitis
Allergic to any drug in this protocol

Other

There is distant organ metastasis (according to AJCC stage, supraclavicular lymph node metastasis is M1, which should be excluded)
Pregnant or lactating women

Who the study is looking for

Age 18-75 years old, gender unlimited
Esophageal squamous cell carcinoma confirmed by histology and unresectable locally advanced or postoperative recurrence
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
ECOG: 0\~1
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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status	Guangzhou	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.