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Clinical Trials in China / NCT06861894
Starting soon Phase 2

Active Surveillance After Neoadjuvant Adebrelimab Combined With Chemoradiotherapy for Resectable ESCC

NCT06861894 · tracked via the Priya Life Science China tracker
Sponsor
Zhigang Li
Phase
Phase 2
Started
2025-07
Last updated
2025-05-15

Condition(s) studied

Esophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Adebrelimab and nab-paclitaxel and carboplatinRadiationstandard oesophagectomyactive surveillance

Adebrelimab and nab-paclitaxel and carboplatin: Adebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy

Radiation: concurrent chemoradiotherapy

standard oesophagectomy: standard oesophagectomy

active surveillance: active surveillance

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Subjects signed the informed consent and volunteered to participate in the study. 2. Esophageal squamous cell carcinoma confirmed by histology or cytology. 3. Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th). 4. Expect to have R0 resection 5. In age from 18 to 75. 6. ECOG PS: 0\~1. 7. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc. 8. No contraindications to surgery. 9. 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 10. 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. 11. Good compliance, willing to comply with follow-up schedules. Exclusion Criteria: 1. Subjects have received or are receiving any of: 1. anti-tumor interventions such as radiotherapy, chemotherapy, or other medications. 2. 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. 3. live vaccine within 4 weeks before the first administration. 4. major surgery or major injury within 4 weeks before the first administration. 2. Cancer-related exclusion criteria 1. other cancers instead of ESCC 2. unresectable or metastatic ESCC 3. not comply with cⅡ-Ⅲ(cT2N1-2M0 or cT3N0-2M0, AJCC 8th) 4. 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) 3. Other criteria 1. 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 2. Subjects with any known active autoimmune disease 3. Pregnant or breastfeeding female 4. Presence of allergy or hypersensitivity to investigational medications 5. 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 6. Investigators assessed there might be other factors that cause subjects to withdraw.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06861894 on ClinicalTrials.gov ↗ ← All trials in China