Trial Title:
Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study
NCT ID:
NCT06663059
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Squamous Cell Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Conditions: Keywords:
Esophageal Squamous Cell Carcinoma
Adebrelimab
Neoadjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle
Description:
Each treatment cycle is 3 weeks long (Q3W), with a total of 2 cycles. Adebrelimab: 1200
mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on
Day 1 and Day 8, administered intravenously, Q3W.
Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W.
Drug infusion should follow this sequence:
Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes
between each infusion.
Arm group label:
Adebrelimab combined with Chemotherapy 2 cycle
Intervention type:
Drug
Intervention name:
Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle
Description:
Each treatment cycle is 3 weeks long (Q3W), with a total of 4 cycles. Adebrelimab: 1200
mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on
Day 1 and Day 8, administered intravenously, Q3W.
Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W.
Drug infusion should follow this sequence:
Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes
between each infusion.
Arm group label:
Adebrelimab combined with Chemotherapy 4 cycle
Summary:
Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined
with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced
thoracic esophageal squamous cell carcinoma.
Detailed description:
This study is a prospective, multicenter, exploratory clinical trial. It involves
patients with resectable locally advanced thoracic esophageal squamous cell carcinoma
confirmed by histopathology or cytology. The study aims to compare the efficacy and
safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as
neoadjuvant treatment for these patients.
Eligible patients will be randomly assigned in a 1:1 ratio to either the 2-cycle group or
the 4-cycle group. The primary endpoint is pathological complete response (pCR), with a
planned enrollment of 80 patients.
The study consists of a screening period (from the signing of the informed consent form
to the first administration of the drug, not exceeding 21 days), a treatment period
(including neoadjuvant therapy and surgery), and a follow-up period (including safety
follow-up, tumor progression/recurrence follow-up, and survival follow-up).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Written informed consent must be signed, and the participant must voluntarily join
the study.
2. Histologically or cytologically confirmed esophageal squamous cell carcinoma.
3. Locally advanced thoracic esophageal cancer assessed by CT/MRI/EUS, with clinical
staging T1b-4aN+M0 or T2-4N0M0 (T2N0 patients must have high-risk factors such as
lymphovascular invasion [LVI], tumor size ≥3 cm, or poor differentiation) (according
to AJCC 8th edition).
4. Expected to achieve R0 resection.
5. Age between 18 and 75 years, regardless of gender.
6. ECOG Performance Status 0-1.
7. No prior treatment for esophageal cancer, including radiotherapy, chemotherapy, or
surgery.
8. Planning to undergo surgery after completing neoadjuvant therapy.
9. No contraindications for surgery.
10. Normal major organ functions, including:
- **Hematology** (no use of blood components, growth factors, white blood cell
stimulants, platelet stimulants, or anemia-correcting drugs within 14 days
before the first use of the study drug):
- Neutrophil count ≥1.5 × 10^9/L
- Platelet count ≥100 × 10^9/L
- Hemoglobin ≥90 g/L
- **Biochemistry**:
- Total bilirubin ≤1.5 × ULN
- ALT ≤2.5 × ULN, AST ≤2.5 × ULN
- Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min
- **Coagulation**:
- International Normalized Ratio (INR) ≤1.5 × ULN
- Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN
11. Female participants of childbearing potential must have a negative serum pregnancy
test within 72 hours before starting the study drug and must use effective
contraception (e.g., intrauterine device, contraceptive pills, or condoms) during
the study and for at least 3 months after the last dose. Male participants with a
fertile partner must be surgically sterilized or agree to use effective
contraception during the study and for 3 months after the last dose.
12. Good compliance with the study and cooperation with follow-up.
Exclusion Criteria:
1. Tumor clearly invading adjacent organs (e.g., major arteries or trachea).
2. Supraclavicular lymph node metastasis.
3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated
drainage.
4. Poor nutritional status, BMI < 18.5 kg/m²; if corrected with symptomatic nutritional
support before randomization, may be considered for inclusion after assessment by
the principal investigator.
5. History of allergy to monoclonal antibodies, Adebrelimab or its components,
paclitaxel, cisplatin, or other platinum-based drugs.
6. Previous or current treatment with:
- Any tumor-directed radiotherapy, chemotherapy, or other anti-tumor drugs.
- Immunosuppressive drugs or systemic steroids (doses > 10 mg/day of prednisone
or equivalent) within 2 weeks prior to the first use of the study drug; inhaled
or topical steroids and adrenal corticosteroids for non-active autoimmune
diseases are allowed.
- Live attenuated vaccines within 4 weeks prior to the first use of the study
drug.
- Major surgery or severe trauma within 4 weeks prior to the first use of the
study drug.
7. Active autoimmune diseases or a history of autoimmune diseases, including but not
limited to: interstitial pneumonia, colitis, hepatitis, pituitaryitis, vasculitis,
nephritis, hyperthyroidism, hypothyroidism (considered if on hormone replacement
therapy); psoriasis or childhood asthma/allergy in complete remission without
intervention can be considered, but those requiring bronchodilators for medical
intervention cannot be included.
8. History of immunodeficiency, including positive HIV test, or other acquired or
congenital immunodeficiencies, or history of organ transplantation or allogeneic
bone marrow transplantation.
9. Poorly controlled cardiac symptoms or diseases, including but not limited to: (1)
NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial
infarction within 1 year, (4) clinically significant supraventricular or ventricular
arrhythmias not controlled or poorly controlled after clinical intervention.
10. Severe infection (CTCAE > 2) within 4 weeks prior to the first use of the study
drug, such as severe pneumonia, bacteremia, or infection complications requiring
hospitalization; active pulmonary inflammation on baseline chest imaging, symptoms
and signs of infection within 14 days prior to the first use of the study drug, or
need for antibiotic treatment, except for prophylactic use.
11. Active pulmonary tuberculosis infection discovered by medical history or CT, or
history of active pulmonary tuberculosis within the past year, or history of active
pulmonary tuberculosis more than 1 year ago without formal treatment.
12. Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10^4 copies/mL) or hepatitis C (positive
HCV antibody, and HCV RNA above the lower limit of detection).
13. Diagnosis of other malignant tumors within 5 years prior to the first use of the
study drug, unless it is a low-risk malignancy (5-year survival rate > 90%), such as
fully treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma
in situ.
14. Pregnant or breastfeeding women.
15. Any condition that, in the investigator's judgment, may lead to withdrawal from the
study, such as other serious illnesses (including mental illnesses) requiring
concurrent treatment, alcohol or drug abuse, family or social factors that may
affect the participant's safety or compliance.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tangdu Hospital Affiliated to the Fourth Military Medical University
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Jiang, Dr
Phone:
13572592311
Email:
jiangtaochest@163.com
Start date:
October 1, 2024
Completion date:
September 1, 2027
Lead sponsor:
Agency:
Tang-Du Hospital
Agency class:
Other
Source:
Tang-Du Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06663059
