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

NCT06508229 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-1316-HLJ-005
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Adebrelimab; Chemotherapy; locally advanced ESCC

Outcome Measures

Primary Outcomes (1)

• pathological complete remission rate

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

  up to 24 months

Secondary Outcomes (9)

• R0 resection rate

  up to 24 months

• Main pathological remission

  up to 24 months

• objective response rate

  up to 24 months

• Disease-free survival

  up to 24 months

• overall survival

  up to 24 months

Study Arms (1)

Immuno-chemotherapy for locally advanced ESCC

EXPERIMENTAL

Adebrelimab + albumin paclitaxel + nedaplatin

Drug: Adebrelimab; Drug: albumin paclitaxel; Drug: Nedaplatin

Interventions

Adebrelimab DRUG

adebrelimab, IV

Also known as: SHR-1316

Immuno-chemotherapy for locally advanced ESCC

albumin paclitaxel DRUG

albumin paclitaxel, iv

Also known as: Injectable paclitaxel (albumin bound)

Immuno-chemotherapy for locally advanced ESCC

Nedaplatin DRUG

Nedaplatin，IV

Also known as: Nedaplatin for injection

Immuno-chemotherapy for locally advanced ESCC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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; 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.

Sponsors & Collaborators

• Harbin Medical University: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

nedaplatin; Injections

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jianqun Ma, MD

  Harbin Medical University Affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqun Ma, MD

CONTACT

+86-13359990466; jianqunma@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: July 18, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share