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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

A Prospective, Multicenter, Phase II Study on the Efficacy and Safety of Cardenilimab Combined With Chemotherapy in the Conversion Therapy of Locally Advanced Esophageal Squamous Cell Carcinoma.

Cardenilimab Combined With Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma (NCT06165380) is a Phase 2 interventional studying Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapies, sponsored by Li Zhang. 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

The goal of this trial is to test the efficacy and safety of cardenilimab combined with chemotherapy in the conversion therapy of locally advanced unresectable esophageal squamous cell carcinoma. type of study: clinical trial

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Squamous Cell Carcinoma 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 43 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\. Sign written willing to sign a consent form before implementing any trial-related procedures; 2. Male or female, age ≥18 years old; 3. Patients with diagnosed by tissue sample (biopsy-confirmed) esophageal squamous cell carcinoma, diagnosed as cT4a, T4b, NXM0 according to the 8th edition of AJCC TNM staging, and assessed as initially unresectable by the surgeon; 4. Have not received any systemic treatment for the current disease in the past, including surgery, anti-tumor radiotherapy, chemotherapy/immunotherapy, etc.; 5. Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no contraindications to surgery 6. ECOG score 0-1 points; 7. Expected survival time \>6 months; 8. With sufficient organ function, subjects must meet the following laboratory indicators: 1. Absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor in the past 14 days; 2. Without blood transfusion in the past 14 days, platelet count at least 100×109/L; 3. Hemoglobin \>9g/dL without blood transfusion or erythropoietin use in the past 14 days; 4. Total bilirubin ≤1.5×upper limit of normal (ULN); 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are within ≤2.5×ULN 6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; 7. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8. Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can also be enrolled if total T3 (or FT3) and FT4 are within the normal range; ...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\. Sign written informed consent before implementing any trial-related procedures; 2. Male or female, age ≥18 years old; 3. Patients with histologically confirmed esophageal squamous cell carcinoma, diagnosed as cT4a, T4b, NXM0 according to the 8th edition of AJCC TNM staging, and assessed as initially unresectable by the surgeon; 4. Have not received any systemic treatment for the current disease in the past, including surgery, anti-tumor radiotherapy, chemotherapy/immunotherapy, etc.; 5. Patients who agree to undergo radical surgical treatment and are judged by the surgeon to have no contraindications to surgery 6. ECOG score 0-1 points; 7. Expected survival time \>6 months; 8. With sufficient organ function, subjects must meet the following laboratory indicators: 1. Absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor in the past 14 days; 2. Without blood transfusion in the past 14 days, platelets ≥100×109/L; 3. Hemoglobin \>9g/dL without blood transfusion or erythropoietin use in the past 14 days; 4. Total bilirubin ≤1.5×upper limit of normal (ULN); 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are within ≤2.5×ULN 6. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml/min; 7. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; 8. Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects can also be enrolled if total T3 (or FT3) and FT4 are within the normal range; 9. Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities without clinical significance are also allowed to be included); 9. Female subjects of childbearing potential should receive a urine or serum pregnancy test with a negative result within 3 days before receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-reproductive age were defined as at least 1 year postmenopausal, or had undergone surgical sterilization or hysterectomy; 10. If there is a risk of pregnancy, all subjects (regardless of male or female) need to use low annual failure rate during the entire treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug). Contraceptive measures at 1%. Exclusion Criteria: 1. Other malignant diseases diagnosed within 5 years before the first dose (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has been radically resected); 2. Endoscopically known signs of active bleeding in the lesion; 3. Currently participating in interventional clinical research treatment, or have received other research drugs or used research equipment within 4 weeks before the first dose; 4. Have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another type of stimulating or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137 etc.) drugs; 5. Have received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion) within 2 weeks before the first dose; 6. Active autoimmune disease that requires systemic treatment (such as the use of disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 7. Are receiving systemic glucocorticoid treatment (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) are allowed; 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. People who are known to be allergic to the drugs used in this study; 10. Those with multiple factors that affect capecitabine (such as inability to swallow, intestinal obstruction, etc.); 11. Have not fully recovered from toxicity and/or complications caused by any intervention before initiating treatment (i.e., ≤Grade 1 or reaching baseline, excluding fatigue or alopecia); 12. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 13. Untreated active hepatitis B (defined as HBsAg positivity and a detected HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled: 1. The HBV viral load before the first dose is \<2500 copies/ml (500 IU/ml), and the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid viral reactivation. 2. Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV treatment, but need to be closely monitored for viral reactivation 14. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level higher than the lower limit of detection); 15. Get live vaccine within 30 days before the first dose (cycle 1, day 1); NOTE: Injectable inactivated virus vaccine for seasonal influenza is allowed within 30 days before the first dose; however, intranasal live attenuated influenza vaccine is not allowed 16. Pregnant or lactating women; 17. The presence of any serious or uncontrollable systemic disease, such as: 1\) The resting electrocardiogram has major abnormalities in rhythm, conduction or morphology that are difficult to control with severe symptoms, such as complete left bundle branch block, second degree or higher heart block, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina, congestive heart failure, New York Heart Association (NYHA) chronic heart failure grade ≥ 2; 3) Any arterial thrombosis, embolism or ischemia occurred within 6 months before selected treatment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient cerebral ischemic attack; 4) Unsatisfactory blood pressure control (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg); 5) There is a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose, or there is currently clinically active interstitial lung disease; 6) Active pulmonary tuberculosis; 7) There is an active or uncontrolled infection that requires systemic treatment; 8) Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction exists; 9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) Poorly controlled diabetes (fasting blood glucose (FBG) \>10mmol/L); 11) Those whose urine routine shows urine protein ≥++, and the 24-hour urine protein quantification is confirmed to be \>1.0 g; 12) Patients with mental disorders and unable to cooperate with treatment; 18. Evidence of medical history or disease, abnormal treatment or laboratory test values that may interfere with the trial results, prevent the subject from fully participating in the study, or other circumstances that the researcher believes are not suitable for enrollment. The researcher believes that there are other potential risks and are not suitable for participation this research.

Treatments Being Tested

DRUG

Cardenilimab Combined With Chemotherapy

Cardenilimab Combined With Chemotherapy

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.

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06165380), the sponsor (Li Zhang), 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 NCT06165380 clinical trial studying?

The goal of this trial is to test the efficacy and safety of cardenilimab combined with chemotherapy in the conversion therapy of locally advanced unresectable esophageal squamous cell carcinoma. type of study: clinical trial The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06165380?

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 NCT06165380?

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 NCT06165380. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06165380. 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 2026-05-08 · Data from ClinicalTrials.gov.