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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Time-of-Day of Immunotherapy Infusion in Neoadjuvant Immunochemotherapy for Thoracic ESCC
ClinicalTrials.gov ID: NCT07452601
What this study is testing
What is Adebrelimab plus nab-paclitaxel and cisplatin?
Adebrelimab plus nab-paclitaxel and cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, multi-cohort, exploratory clinical study designed to evaluate the efficacy and safety of neoadjuvant adebrelimab combined with chemotherapy in patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC), with a particular focus on the effect of the time-of-day of immunotherapy infusion. Eligible patients with histologically or cytologically confirmed, resectable locally advanced thoracic ESCC will be randomly assigned in a 1:1:1 ratio to three cohorts according to predefined immunotherapy infusion time windows.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients who have signed a written informed consent form and voluntarily agree to participate in the study.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma.
- Tumor located in the thoracic esophagus, assessed by CT, MRI, EUS, or other imaging modalities, with clinical stage T1b-4aN+M0 or T2-4N0M0 (T2N0...
- Tumors deemed potentially resectable with R0 margins.
- Age between 18 and 75 years, male or female.
You likely can't join if
- Tumor with obvious invasion of adjacent critical structures, such as the aorta or trachea.
- Presence of supraclavicular lymph node metastasis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Poor nutritional status with body mass index (BMI) \<18.5 kg/m²; patients whose nutritional status is corrected before randomization through...
- Known hypersensitivity to monoclonal antibodies, adebrelimab, nab-paclitaxel, cisplatin, or other platinum-based agents.
- Prior or ongoing treatments as follows:
See the full eligibility criteria
Who can join
- Patients who have signed a written informed consent form and voluntarily agree to participate in the study.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma.
- Tumor located in the thoracic esophagus, assessed by CT, MRI, EUS, or other imaging modalities, with clinical stage T1b-4aN+M0 or T2-4N0M0 (T2N0 patients must have high-risk features: lymphovascular invasion [LVI]...
- Tumors deemed potentially resectable with R0 margins.
- Age between 18 and 75 years, male or female.
- ECOG performance status of 0 or 1.
- No prior anti-tumor treatment for esophageal cancer, including surgery, radiotherapy, or chemotherapy.
- Planned to undergo surgery after completion of neoadjuvant therapy.
- No contraindications to surgery.
- Adequate organ function, including:
- Hematologic parameters(no blood products, growth factors, erythropoiesis-stimulating agents, or platelet-stimulating drugs within 14 days prior to first study drug administration): Absolute neutrophil count ≥1.5 ×...
- Biochemical parameters:Total bilirubin ≤1.5 × ULN; ALT ≤2.5 × ULN, AST ≤2.5 × ULN;Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min.
- Coagulation parameters:International normalized ratio (INR) ≤1.5 × ULN; Activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- For women of childbearing potential, a negative serum pregnancy test within 72 hours prior to first study drug administration and agreement to use effective contraception during the study and for at least 3 months after...
- Good compliance and willingness to adhere to study procedures and follow-up. ---
What rules you out
- Tumor with obvious invasion of adjacent critical structures, such as the aorta or trachea.
- Presence of supraclavicular lymph node metastasis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Poor nutritional status with body mass index (BMI) \<18.5 kg/m²; patients whose nutritional status is corrected before randomization through supportive care may be considered eligible at the discretion of the principal...
- Known hypersensitivity to monoclonal antibodies, adebrelimab, nab-paclitaxel, cisplatin, or other platinum-based agents.
- Prior or ongoing treatments as follows:
- Any prior anti-tumor therapy, including chemotherapy, radiotherapy, or other anti-cancer drugs;
- Use of systemic immunosuppressive therapy or corticosteroids for immunosuppression (\>10 mg/day prednisone or equivalent) within 2 weeks prior to first study drug administration. Inhaled or local steroid use and...
- Administration of live attenuated vaccines within 4 weeks prior to first study drug administration;
- Major surgery or severe trauma within 4 weeks prior to first study drug administration.
- Active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients on...
- History of immunodeficiency, including positive HIV test, other congenital or acquired immunodeficiency, or history of organ or allogeneic bone marrow transplantation.
- Uncontrolled clinically significant cardiac conditions, including but not limited to: NYHA class II or higher heart failure;Unstable angina;Myocardial infarction within 1 year;Clinically significant supraventricular or...
- Severe infection (CTCAE \> grade 2) within 4 weeks prior to first study drug administration requiring hospitalization, including severe pneumonia, bacteremia, or infectious complications. Patients with active pulmonary...
- Active pulmonary tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or history of untreated active tuberculosis more than 1 year prior to enrollment.
- Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C infection (positive HCV antibody with HCV RNA above the assay detection limit).
- Diagnosis of other malignancies within the past 5 years, except for tumors with low risk of metastasis or mortality (5-year survival \>90%), such as adequately treated basal cell carcinoma, squamous cell carcinoma of...
- Pregnant or breastfeeding women.
- Any other condition that, in the opinion of the investigator, could lead to premature discontinuation of study treatment or compromise participant safety or compliance, including serious comorbidities (including...
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shannxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shannxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.