Ireland
--:--IST
Starting soon Phase 2

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

NCT06178211 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2023-12
Last updated
2023-12-20

Condition(s) studied

Esophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Immunotherapy: Adebrelimab →chemotherapy: carboplatin plus nab-paclitaxel →

Immunotherapy: Adebrelimab: Adebrelimab 1200mg Q3W

chemotherapy: carboplatin plus nab-paclitaxel: carboplatin plus nab-paclitaxel

Study 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).

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 medictions. 2. 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. 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. non-recetable 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 arrthymia 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 withdrawl.

Primary outcome measure(s)

  • pCR rate — 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.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Chest Hospital Shanghai China
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 NCT06178211 on ClinicalTrials.gov ↗ ← All trials in China