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

Shanghai Chest Hospital1 site in 1 country36 target enrollmentDecember 2023

ConditionsEsophageal Squamous Cell Carcinoma

DrugsImmunotherapy: Adebrelimab chemotherapy: carboplatin plus nab-paclitaxel

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Shanghai Chest Hospital
Enrollment: 36
Locations: 1
Primary Endpoint: pCR rate
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

December 2023

End Date

November 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Chest Hospital

Responsible Party

Principal Investigator

Zhigang Li

Chief of Department of Esophageal Surgery

Shanghai Chest Hospital

Eligibility Criteria

Inclusion Criteria

•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
•ECOG PS: 0\~
•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.

Exclusion Criteria

•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.
•Cancer related exclusion criteria
•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)

Outcomes

Primary Outcomes

pCR rate

Time Frame: 12 months

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.

Secondary Outcomes

cCR rate(12 months)
R0 resection rate(12 months)
MPR rate(12 months)
median EFS(12 months)
median OS(12 months)
Incidence, type and severity of adverse events as assessed by CTCAE 5.0(From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose)
Potential biomarkers such as ctDNA or PD-L1 expression(12 months)