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New treatment option for Esophageal Squamous Cell Carcinoma (ESCC)
Official title Adebrelimab Combined With Neoadjuvant Chemotherapy in Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07638436
What this study is testing
What is Adebrelimab Injection?
Adebrelimab Injection is an investigational medicine, being studied as a potential treatment for esophageal squamous cell carcinoma (escc).
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 clinical trial aims to preliminarily evaluate the efficacy and safety of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for borderline resectable locally advanced esophageal squamous cell carcinoma (ESCC). The primary research objectives are to increase the R0 resection rate in such patients, thereby reducing the recurrence rate and improving overall survival (OS), as well as avoiding adverse reactions associated with radiotherapy.
- 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
- 1.Voluntarily participate in the study and sign the written informed consent form.
- 2.Aged between 18 and 75 years old. 3.Histologically confirmed thoracic esophageal squamous cell carcinoma without distant metastasis. Patients are...
- 4.No prior chemotherapy or radiotherapy. 5.Estimated overall survival of no less than 3 months. 6.Eastern Cooperative Oncology Group Performance...
- 7.Hematological parameters (tested within 7 days): Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (NE) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L.
- 8.Hepatic and renal function (tested within 7 days): Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Creatinine ≤ 1.5 × ULN; Aspartate...
You likely can't join if
- Patients with cervical esophageal squamous cell carcinoma.
- Patients with distant metastasis.
- Patients with nearly complete esophageal obstruction confirmed by endoscopy who require treatment therapy for decompression.
- Patients with prior placement of esophageal or tracheal stents.
- Patients with high risk of bleeding or perforation due to obvious tumor invasion into adjacent vital organs (major arteries or trachea), or patients...
- Patients with other concurrent primary malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
See the full eligibility criteria
- 1.Voluntarily participate in the study and sign the written informed consent form.
- 2.Aged between 18 and 75 years old. 3.Histologically confirmed thoracic esophageal squamous cell carcinoma without distant metastasis. Patients are defined as borderline resectable after enhanced computed tomography...
- 4.No prior chemotherapy or radiotherapy. 5.Estimated overall survival of no less than 3 months. 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- 7.Hematological parameters (tested within 7 days): Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (NE) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L.
- 8.Hepatic and renal function (tested within 7 days): Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Creatinine ≤ 1.5 × ULN; Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase...
- 9.Absence of severe complications, including active massive gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, and non-neoplastic fever above 38°C.
- 10.Fertile patients must adopt effective contraceptive measures throughout the study period.
- 11.Good treatment compliance, and able to complete follow-up assessments for how well it works and adverse events as required by the protocol.
- Patients with cervical esophageal squamous cell carcinoma.
- Patients with distant metastasis.
- Patients with nearly complete esophageal obstruction confirmed by endoscopy who require treatment therapy for decompression.
- Patients with prior placement of esophageal or tracheal stents.
- Patients with high risk of bleeding or perforation due to obvious tumor invasion into adjacent vital organs (major arteries or trachea), or patients with existing fistula formation.
- Patients with other concurrent primary malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
- Use of immunosuppressive drugs within 1 week prior to enrollment. This exclusion does not apply to intranasal, inhaled or other topical glucocorticoids, systemic glucocorticoids at physiological doses (i.e., prednisone...
- Active autoimmune diseases requiring symptomatic treatment, or a medical history of such diseases within the past 2 years.
- Known history of primary immunodeficiency.
- Confirmed active tuberculosis.
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Interstitial lung disease requiring corticosteroid therapy. 13Known allergy to any monoclonal antibody, chemotherapeutic agents (taxanes, carboplatin), or their excipients. 14.Severe cardiac diseases, including...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.