Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC
1 other identifier
interventional
164
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
May 15, 2025
March 1, 2025
1.7 years
March 3, 2025
May 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
2-year OS rate
An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence.
24 months
Secondary Outcomes (6)
cCR rate
12 months
median EFS
24 months
median OS
24 months
Incidence, type and severity of adverse events as assessed by CTCAE 5.0
24 months
quality of life (QOL)
24 months
- +1 more secondary outcomes
Study Arms (1)
perioperative treatment with adebrelimab and CRT
EXPERIMENTALInterventions
standard oesophagectomy
Adebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy
Eligibility Criteria
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 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.
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhigang Lilead
Study Sites (1)
Shanghai Chest Hospital
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief of Department of Esophageal Surgery
Study Record Dates
First Submitted
March 3, 2025
First Posted
March 6, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2029
Last Updated
May 15, 2025
Record last verified: 2025-03