Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC

Official title

Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable Esophageal Squamous Cell Carcinoma

Overview

In this prospective trial, patients demonstrating clinical complete response (cCR) as determined by a standard response assessment protocol (incorporating clinical and molecular diagnostic methods) will be offered organ-sparing management following neoadjuvant therapy with adebrelimab (anti-PD-L1) concurrent with chemoradiotherapy. The primary endpoint is 2-year overall survival rate in this watch-and-wait cohort.

Interventions

• Drug Adebrelimab and nab-paclitaxel and carboplatin
  Adebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy
• Radiation Radiation
  concurrent chemoradiotherapy
• Procedure standard oesophagectomy
  standard oesophagectomy
• Other active surveillance
  active surveillance

Primary outcome measures

• 2-year OS rate [Time frame: 24 months]

Secondary outcome measures (6)

• cCR rate [Time frame: 12 months]
• median EFS [Time frame: 24 months]
• median OS [Time frame: 24 months]
• Incidence, type and severity of adverse events as assessed by CTCAE 5.0 [Time frame: 24 months]
• quality of life (QOL) [Time frame: 24 months]
• quality of life (QOL) assessed by EORTC QLQ-OES18 [Time frame: 24 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 medications.
• immunosuppressants 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
• unresectable 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 arrhythmia 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 withdraw.

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: NCT06861894 · MA-EC-II-017

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗