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Not yet recruiting NCT06178211

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

Phase II Interventional Esophageal Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immunotherapy: Adebrelimab, chemotherapy: carboplatin plus nab-paclitaxel.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Drug Immunotherapy: Adebrelimab
    Adebrelimab 1200mg Q3W
  • Drug chemotherapy: carboplatin plus nab-paclitaxel
    carboplatin plus nab-paclitaxel

Primary outcome measures

  • pCR rate [Time frame: 12 months]
Secondary outcome measures (7)
  • cCR rate [Time frame: 12 months]
  • R0 resection rate [Time frame: 12 months]
  • MPR rate [Time frame: 12 months]
  • median EFS [Time frame: 12 months]
  • median OS [Time frame: 12 months]
  • Incidence, type and severity of adverse events as assessed by CTCAE 5.0 [Time frame: 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 [Time frame: 12 months]

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 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.

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)
  • 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
  • Investigators assessed there might be other factors that cause subjects to withdrawl.

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

China · 1 center
  • Shanghai Chest Hospital — Shanghai

Identifiers

NCT: NCT06178211 · MA-EC-II-015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗