Neoadjuvant Adebrelimab Plus Chemotherapy for Resectable ESCC: a Single Arm, Prospective Phase 2 Clinical Trial
NCT ID: NCT06178211
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2023-12-31
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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adebrelimab and chemotherapy
Immunotherapy: Adebrelimab
Adebrelimab 1200mg Q3W
chemotherapy: carboplatin plus nab-paclitaxel
carboplatin plus nab-paclitaxel
Interventions
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Immunotherapy: Adebrelimab
Adebrelimab 1200mg Q3W
chemotherapy: carboplatin plus nab-paclitaxel
carboplatin plus nab-paclitaxel
Eligibility Criteria
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Inclusion Criteria
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. 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.
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Zhigang Li
Chief of Department of Esophageal Surgery
Locations
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Shanghai Chest Hospital
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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MA-EC-II-015
Identifier Type: -
Identifier Source: org_study_id