Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study

NCT06663059 | Recruiting Phase 2 DMC

• 1 other identifier: IIT20240709
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma.

Conditions

Esophageal Cancer

Keywords

Esophageal Squamous Cell Carcinoma; Adebrelimab; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate(pCR)

  The lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with radiation or chemotherapy.

  7 days after surgery

Secondary Outcomes (3)

• Major pathologic response (MPR)

  7 days after surgery

• R0 resection rate

  postoperative 6 hours

• Event-free survival (EFS)

  up to 2 years

Study Arms (2)

Adebrelimab combined with Chemotherapy 2 cycle

EXPERIMENTAL

Adebrelimab combined with albumin-bound paclitaxel and cisplatin for 2 cycles, followed by surgical resection.

Drug: Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle

Adebrelimab combined with Chemotherapy 4 cycle

EXPERIMENTAL

Adebrelimab combined with albumin-bound paclitaxel and cisplatin for 4 cycles, followed by surgical resection.

Drug: Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle

Interventions

Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle DRUG

Each treatment cycle is 3 weeks long (Q3W), with a total of 2 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.

Adebrelimab combined with Chemotherapy 2 cycle

Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle DRUG

Each treatment cycle is 3 weeks long (Q3W), with a total of 4 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.

Adebrelimab combined with Chemotherapy 4 cycle

Eligibility Criteria

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

You may qualify if:

• Written informed consent must be signed, and the participant must voluntarily join the study.
• Histologically or cytologically confirmed esophageal squamous cell carcinoma.
• Locally advanced thoracic esophageal cancer assessed by CT/MRI/EUS, with clinical staging T1b-4aN+M0 or T2-4N0M0 (T2N0 patients must have high-risk factors such as lymphovascular invasion \[LVI\], tumor size ≥3 cm, or poor differentiation) (according to AJCC 8th edition).
• Expected to achieve R0 resection.
• Age between 18 and 75 years, regardless of gender.
• ECOG Performance Status 0-1.
• No prior treatment for esophageal cancer, including radiotherapy, chemotherapy, or surgery.
• Planning to undergo surgery after completing neoadjuvant therapy.
• No contraindications for surgery.
• Normal major organ functions, including:
• \*\*Hematology\*\* (no use of blood components, growth factors, white blood cell stimulants, platelet stimulants, or anemia-correcting drugs within 14 days before the first use of the study drug):
• Neutrophil count ≥1.5 × 10\^9/L
• Platelet count ≥100 × 10\^9/L
• Hemoglobin ≥90 g/L
• \*\*Biochemistry\*\*:

You may not qualify if:

• Tumor clearly invading adjacent organs (e.g., major arteries or trachea).
• Supraclavicular lymph node metastasis.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• History of allergy to monoclonal antibodies, Adebrelimab or its components, paclitaxel, cisplatin, or other platinum-based drugs.
• Previous or current treatment with:
• Any tumor-directed radiotherapy, chemotherapy, or other anti-tumor drugs.
• Immunosuppressive drugs or systemic steroids (doses \> 10 mg/day of prednisone or equivalent) within 2 weeks prior to the first use of the study drug; inhaled or topical steroids and adrenal corticosteroids for non-active autoimmune diseases are allowed.
• Live attenuated vaccines within 4 weeks prior to the first use of the study drug.
• Major surgery or severe trauma within 4 weeks prior to the first use of the study drug.
• Active autoimmune diseases or a history of autoimmune diseases, including but not limited to: interstitial pneumonia, colitis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered if on hormone replacement therapy); psoriasis or childhood asthma/allergy in complete remission without intervention can be considered, but those requiring bronchodilators for medical intervention cannot be included.
• History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiencies, or history of organ transplantation or allogeneic bone marrow transplantation.
• Poorly controlled cardiac symptoms or diseases, including but not limited to: (1) NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias not controlled or poorly controlled after clinical intervention.
• Severe infection (CTCAE \> 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, or infection complications requiring hospitalization; active pulmonary inflammation on baseline chest imaging, symptoms and signs of infection within 14 days prior to the first use of the study drug, or need for antibiotic treatment, except for prophylactic use.
• Active pulmonary tuberculosis infection discovered by medical history or CT, or history of active pulmonary tuberculosis within the past year, or history of active pulmonary tuberculosis more than 1 year ago without formal treatment.
• Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10\^4 copies/mL) or hepatitis C (positive HCV antibody, and HCV RNA above the lower limit of detection).

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital Affiliated to the Fourth Military Medical University

Xi'an, Shannxi, 710038, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Tao Jiang, Dr

  Tangdu hospital, The air force military university

  STUDY CHAIR

Central Study Contacts

Tao Jiang, Dr

CONTACT

13572592311; jiangtaochest@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: October 29, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)