Clinical Trials/NCT06508229

NCT06508229

Not yet recruiting

Phase 2

Adebrelimab Combined With Albumin Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma：a Prospective, Single Arm, Phase 2 Clinical Study

Harbin Medical University0 sites65 target enrollmentJuly 30, 2024

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsAdebrelimab albumin paclitaxel Nedaplatin

Overview

Phase: Phase 2
Intervention: Adebrelimab
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Harbin Medical University
Enrollment: 65
Primary Endpoint: pathological complete remission rate
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a multi-center, single-arm, phase II clinical study designed to observe and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.

Detailed Description

This study plans to include 65 patients who received 3 cycles of neoadjuvant therapy (Adebrelimab + albumin paclitaxel + nedaplatin) , and underwent surgery after the treatment was completed. The purpose of this study is to explore and evaluate the effectiveness and safety of adebrelimab combined with albumin paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma.

Registry

clinicaltrials.gov

Start Date

July 30, 2024

End Date

May 30, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Harbin Medical University

Responsible Party

Principal Investigator

Jianqun Ma

Harbin Medical University

Eligibility Criteria

Inclusion Criteria

•Age: 18 to 75 years old, no limit to male or female;
•Surgically resectable locally advanced esophageal squamous cell carcinoma confirmed by histology or cytology (clinical stage: stage IIa-IIIb);
•Have measurable lesions and meet RECIST v1.1) standards;
•Have not received any anti-tumor systemic treatment for esophageal cancer in the past;
•ECOG PS: 0-1 points;
•Expected survival ≥12 weeks;
•The functions of vital organs meet the following requirements:
•Routine blood examination (no blood transfusion within 14 days, no correction with hematopoietic stimulating factor drugs):Hemoglobin (Hb) ≥90 g/L; absolute neutrophil count (ANC) ≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell count (WBC) ≥3.0×109/L;
•Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; serum total bilirubin (TBIL) ≤1.5×ULN (Gilbert syndrome subjects, ≤ 3×ULN); serum creatinine (Cr) ≤1.5 ×ULN or creatinine clearance ≥50ml/min;
•Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) ≤1.5×ULN;

Exclusion Criteria

•Patients with locked lymph node metastasis;
•Have a history of other malignant tumors in the past 5 years, except for cervical carcinoma in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled;
•Suffering from bleeding disorders or a history of bleeding disorders;
•Have undergone major surgery or serious trauma within 4 weeks before taking the study drug for the first time;
•Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
•Have a history of interstitial lung disease and non-infectious pneumonia;
•Suffering from active autoimmune diseases or a history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or reduced thyroid function after thyroid hormone replacement therapy can be included;
•Have a history of immunodeficiency, including testing positive for HIV, suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
•Subjects have cardiovascular clinical symptoms or diseases that cannot be well controlled, including but not limited to:
•NYHA class II or above heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention;

Arms & Interventions

Immuno-chemotherapy for locally advanced ESCC

Adebrelimab + albumin paclitaxel + nedaplatin

Intervention: Adebrelimab

Immuno-chemotherapy for locally advanced ESCC

Adebrelimab + albumin paclitaxel + nedaplatin

Intervention: albumin paclitaxel

Immuno-chemotherapy for locally advanced ESCC

Adebrelimab + albumin paclitaxel + nedaplatin

Intervention: Nedaplatin

Outcomes

Primary Outcomes

pathological complete remission rate

Time Frame: up to 24 months

After neoadjuvant therapy and surgery, there were no residual surviving tumor cells in the tumor bed in the postoperative specimens (% RVT=0)

Secondary Outcomes

R0 resection rate(up to 24 months)
objective response rate(up to 24 months)
Main pathological remission(up to 24 months)
Disease-free survival(up to 24 months)
overall survival(up to 24 months)
Number of participants with treatment related adverse events asassessed by CTCAE v5.0(up to 24 months)
Changes in the patient's mood(up to 24 months)
The patient's nutritional status(up to 24 months)
The pain level of patients(up to 24 months)