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Compares treatment options for Esophageal Cancer
Official title Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study
ClinicalTrials.gov ID: NCT06663059
What this study is testing
What is Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle?
Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Written informed consent must be signed, and the participant must voluntarily join the study.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma.
- 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...
- Expected to achieve R0 resection.
- Age between 18 and 75 years, regardless of gender.
You likely can't join if
- Tumor clearly invading adjacent organs (e.g., major arteries or trachea).
- Supraclavicular lymph node metastasis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Poor nutritional status, BMI \< 18.5 kg/m²; if corrected with symptomatic nutritional support before randomization, may be considered for inclusion...
- History of allergy to monoclonal antibodies, Adebrelimab or its components, paclitaxel, cisplatin, or other platinum-based drugs.
- Previous or current treatment with:
See the full eligibility criteria
- Written informed consent must be signed, and the participant must voluntarily join the study.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma.
- 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...
- Expected to achieve R0 resection.
- Age between 18 and 75 years, regardless of gender.
- ECOG Performance Status 0-1.
- No prior treatment for esophageal cancer, including radiotherapy, chemotherapy, or surgery.
- Planning to undergo surgery after completing neoadjuvant therapy.
- No contraindications for surgery.
- 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
- 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...
- Good compliance with the study and cooperation with follow-up.
- Tumor clearly invading adjacent organs (e.g., major arteries or trachea).
- Supraclavicular lymph node metastasis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- 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.
- History of allergy to monoclonal antibodies, Adebrelimab or its components, paclitaxel, cisplatin, or other platinum-based drugs.
- 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...
- 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.
- Active autoimmune diseases or a history of autoimmune diseases, including but not limited to: interstitial pneumonia, colitis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered...
- History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiencies, or history of organ transplantation or allogeneic bone marrow transplantation.
- 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...
- 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...
- 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...
- 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).
- 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...
- Pregnant or breastfeeding women.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shannxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shannxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.