Adebrelimab Combined With Neoadjuvant Chemotherapy in Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Phase II Trial of Adebrelimab Combined With Nab-paclitaxel and Carboplatin for Neoadjuvant Therapy in Patients With Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Adebrelimab Combined With Neoadjuvant Chemotherapy in Borderline Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NCT07638436) is a Phase 2 interventional studying Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Sun Yat-sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This clinical trial aims to preliminarily evaluate the efficacy and safety of adebrelimab combined with albumin-bound paclitaxel and carboplatin as neoadjuvant therapy for borderline resectable locally advanced esophageal squamous cell carcinoma (ESCC). The primary research objectives are to increase the R0 resection rate in such patients, thereby reducing the recurrence rate and improving overall survival (OS), as well as avoiding adverse reactions associated with radiotherapy.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Squamous Cell Carcinoma (ESCC) 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.

With a target enrollment of 42 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify:1.Voluntarily participate in the study and sign the written willing to sign a consent form form. 2.Aged between 18 and 75 years old. 3.diagnosed by tissue sample (biopsy-confirmed) thoracic esophageal squamous cell carcinoma without distant metastasis. Patients are defined as borderline resectable after enhanced computed tomography (CT), and/or endoscopic ultrasonography (EUS), endobronchial ultrasonography (EBUS) and multidisciplinary team (MDT) discussion. 4.No prior chemotherapy or radiotherapy. 5.Estimated overall survival of no less than 3 months. 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. 7.Hematological parameters (tested within 7 days): Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (NE) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L. 8.Hepatic and renal function (tested within 7 days): Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Creatinine ≤ 1.5 × ULN; Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 5.0 × ULN. 9.Absence of severe complications, including active massive gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, and non-neoplastic fever above 38°C. 10.Fertile patients must adopt effective contraceptive measures throughout the study period. 11.Good treatment compliance, and able to complete follow-up assessments for efficacy and adverse events as required by the protocol. Who Should NOT Join This Trial: 1. Patients with cervical esophageal squamous cell carcinoma. 2. Patients with distant metastasis. 3. Patients with nearly complete esophageal obstruction confirmed by endoscopy who require interventional therapy for decompression. 4. Patients with prior placement of esophageal or tracheal stents. 5. Patients with high risk of bleeding or perforation due to obvious tumor invasion into adjacent vital organs (major arteries or trachea), or patients with existing fistula formation. ...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.Voluntarily participate in the study and sign the written informed consent form. 2.Aged between 18 and 75 years old. 3.Histologically confirmed thoracic esophageal squamous cell carcinoma without distant metastasis. Patients are defined as borderline resectable after enhanced computed tomography (CT), and/or endoscopic ultrasonography (EUS), endobronchial ultrasonography (EBUS) and multidisciplinary team (MDT) discussion. 4.No prior chemotherapy or radiotherapy. 5.Estimated overall survival of no less than 3 months. 6.Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. 7.Hematological parameters (tested within 7 days): Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (NE) ≥ 1.5×10⁹/L; Platelet count (PLT) ≥ 100×10⁹/L. 8.Hepatic and renal function (tested within 7 days): Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Creatinine ≤ 1.5 × ULN; Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 5.0 × ULN. 9.Absence of severe complications, including active massive gastrointestinal bleeding, perforation, jaundice, intestinal obstruction, and non-neoplastic fever above 38°C. 10.Fertile patients must adopt effective contraceptive measures throughout the study period. 11.Good treatment compliance, and able to complete follow-up assessments for efficacy and adverse events as required by the protocol. Exclusion Criteria: 1. Patients with cervical esophageal squamous cell carcinoma. 2. Patients with distant metastasis. 3. Patients with nearly complete esophageal obstruction confirmed by endoscopy who require interventional therapy for decompression. 4. Patients with prior placement of esophageal or tracheal stents. 5. Patients with high risk of bleeding or perforation due to obvious tumor invasion into adjacent vital organs (major arteries or trachea), or patients with existing fistula formation. 6. Patients with other concurrent primary malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). 7. Use of immunosuppressive drugs within 1 week prior to enrollment. This exclusion does not apply to intranasal, inhaled or other topical glucocorticoids, systemic glucocorticoids at physiological doses (i.e., prednisone ≤ 10 mg/day or equivalent), or glucocorticoids administered for contrast medium allergy prophylaxis. 8. Active autoimmune diseases requiring symptomatic treatment, or a medical history of such diseases within the past 2 years. 9. Known history of primary immunodeficiency. 10. Confirmed active tuberculosis. 11. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 12. Interstitial lung disease requiring corticosteroid therapy. 13Known allergy to any monoclonal antibody, chemotherapeutic agents (taxanes, carboplatin), or their excipients. 14.Severe cardiac diseases, including documented congestive heart failure, uncontrolled high-risk arrhythmia, medically treated angina pectoris, clinically significant valvular heart disease, history of severe myocardial infarction, and refractory hypertension. 15.Chronic diarrhea (≥4 watery stools per day) or renal insufficiency. 16.Active infection or active communicable diseases. 17.Neurological or psychiatric disorders impairing cognitive function. 18.Pregnant or breastfeeding women. 19.Other acute or chronic diseases, psychiatric disorders or abnormal laboratory findings that, in the investigator's judgment, may increase risks related to study participation or study drug administration, or interfere with the interpretation of study results.

Treatments Being Tested

DRUG

Adebrelimab Injection

Study participants shall complete the informed consent process and undergo multidisciplinary team (MDT) review for esophageal cancer. Patients confirmed as having borderline resectable disease and meeting all inclusion/exclusion criteria will be enrolled and receive treatment with adebrelimab plus albumin-bound paclitaxel and carboplatin.The treatment regimen is administered in 3-week cycles. Efficacy evaluation will be performed after 2 cycles.

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.

No. 651 Dongfeng East Road, Guangzhou

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07638436), the sponsor (Sun Yat-sen University), 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 NCT07638436 clinical trial studying?

Who can participate in NCT07638436?

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 NCT07638436?

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.

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Source: ClinicalTrials.gov API v2 record for NCT07638436. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07638436. 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.