Adebrelimab Combined With Albumin Paclitaxel and Nedaplatin as Neoadjuvant Therapy for Locally Advanced Resectable ESCC

Official title

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

Overview

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.

Interventions

• Drug Adebrelimab
  adebrelimab, IV
• Drug albumin paclitaxel
  albumin paclitaxel, iv
• Drug Nedaplatin
  Nedaplatin，IV

Primary outcome measures

• pathological complete remission rate [Time frame: up to 24 months]

Secondary outcome measures (9)

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

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;
• Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥50%;
• Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method during the study treatment period and within 3 months after the end of the study treatment period; female patients of childbearing age who have non-surgical sterilization must use a medically approved contraceptive method before study enrollment. The serum or urine HCG test must be negative within 72 hours; and must be non-lactating; for males, they should be surgically sterilized, or agree to use appropriate contraceptive methods during the trial and within 3 months after the last administration of the trial drug;
• The patient voluntarily joined this study, signed the informed consent form (ICF), had good compliance, and cooperated with the follow-up.

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:

1\) 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; 10. Severe active infection requiring intravenous antibiotic treatment occurs within 4 weeks before using the study drug; 11. Those who are allergic to experimental drugs; 12. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits; 13. Those who the researcher believes are not suitable to participate in this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06508229 · SHR-1316-HLJ-005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗