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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study

A Prospective, Multicenter, Exploratory Study Comparing 2 Cycles Versus 4 Cycles of Adebrelimab Combined With Chemotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Adebrelimab Neoadjuvant Treatment for Resectable ESCC: 2 vs 4 Cycles Study (NCT06663059) is a Phase 2 interventional studying Esophageal Cancer, sponsored by Tang-Du Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 80 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Esophageal Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Written willing to sign a consent form must be signed, and the participant must voluntarily join the study. 2. diagnosed by tissue sample (biopsy-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. You should be able to carry out daily activities with 0 level of ability (ECOG 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 - blood count (hemoglobin) at least 90 g/L - \*\*Biochemistry\*\*: - Total bilirubin ≤1.5 × ULN - ALT ≤2.5 × ULN, AST ≤2.5 × ULN - Serum creatinine ≤1.5 × ULN, or kidney function (creatinine clearance) at least 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Adebrelimab combined with albumin-bound paclitaxel and cisplatin 2 cycle

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.

DRUG

Adebrelimab combined with albumin-bound paclitaxel and cisplatin 4 cycle

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06663059), the sponsor (Tang-Du Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06663059 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06663059?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06663059?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06663059. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06663059. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.