Neoadjuvant Adebrelimab Plus Chemotherapy for Resectable ESCC: a Single Arm, Prospective Phase 2 Clinical Trial

NCT06178211 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: MA-EC-II-015
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a single-arm prospective study to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab (SHR-1316) and chemotherapy in patients with resectable esophageal squamous cell carcinoma (ESCC).

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• pCR rate

  The primary endpoint is a pCR rate, which is defined as the absence of any remaining tumor cells in both the main tumor and the nearby lymph nodes (ypT0N0) as per the AJCC 8th Edition TRG scoring system.

  12 months

Secondary Outcomes (7)

• cCR rate

  12 months

• R0 resection rate

  12 months

• MPR rate

  12 months

• median EFS

  12 months

• median OS

  12 months

Study Arms (1)

adebrelimab and chemotherapy

EXPERIMENTAL

Drug: Immunotherapy: Adebrelimab; Drug: chemotherapy: carboplatin plus nab-paclitaxel

Interventions

Immunotherapy: Adebrelimab DRUG

Adebrelimab 1200mg Q3W

adebrelimab and chemotherapy

chemotherapy: carboplatin plus nab-paclitaxel DRUG

carboplatin plus nab-paclitaxel

adebrelimab and chemotherapy

Eligibility Criteria

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

You may qualify if:

• Subjects signed the informed consent and volunteered to participate in the study.
• Esophageal squamous cell carcinoma confirmed by histology or cytology.
• Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th).
• Expect to have R0 resection
• In age from 18 to 75.
• ECOG PS: 0\~1.
• Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
• No contraindications to surgery.
• Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5; APTT≤1.5×ULN
• Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to three months after last administration.
• Good compliance, willing to comply with follow-up schedules.

You may not qualify if:

• Subjects have received or are receiving any of:
• anti-tumor interventions such as radiotherapy, chemotherapy or other medictions.
• immunosuppresants or systemic glucosteroids (prednisone equivalence\> 10mg/d) within 2 weeks before the first administration, inhaled or topical use of glucosteroids (prednisone equivalence\>10mg/d) is allowed if no known active autoimmune disease.
• live vaccine within 4 weeks before the first administration.
• major surgery or major injury within 4 weeks before the first administration.
• other cancers instead of ESCC
• non-recetable or metastatic ESCC
• not comply with cⅡ-Ⅲ（cT2N1-2M0 or cT3N0-2M0, AJCC 8th）
• Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, localized prostate cancer received radical surgery and ductal carcinoma in situ that have received radical treatment and do not need other treatment can be included)
• Other criteria
• Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrthymia that needs treatment
• Subjects with any known active autoimmune disease
• Pregnant or breastfeeding female
• Presence of allergy or hypersensitivity to investigational medications
• HIV positive or active hepatitis B (HbsAg positive and HBV-DNA ≥2000 IU/ml or ≥ 104 copies/mL) or active hepatitis C (HCV antibody positive) or active tuberculosis

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

130-nm albumin-bound paclitaxel

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

Central Study Contacts

Zhigang Li, MD, PhD

CONTACT

18960619260; dr_lizhigang@163.com

Yang Yang

CONTACT

86 21-22200000*2116; yangyang@shsmu.edu.cn

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: Chief of Department of Esophageal Surgery

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: December 20, 2023
• Study Start: December 1, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

CN (1)