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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma

Open-label, Single-arm, Multicenter Phase II Study of Nimotuzumab Injection Combined With Sintilimab and Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma

Nimotuzumab Combined With Sintilimab and Chemotherapy for Advanced Esophageal Squamous Cell Carcinoma (NCT06718205) is a Phase 2 interventional studying Esophageal Cancer, sponsored by The First Affiliated Hospital of Zhengzhou University. 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

This study is a prospective, single-arm, multicenter study. The patients were given chemotherapy with nimotuzumab and sindilimab. To analyze the efficacy and safety of nimotuzumab combined with sindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer.

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 112 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: All of the following participants will be enrolled in this trial: 1. Patients voluntarily joined the study, signed willing to sign a consent form, good compliance and follow-up. 2. unresectable locally advanced, unresectable recurrent or metastatic ESCC confirmed by histopathology (excluding mixed adenosquamous cell carcinoma type); 3. Patients who have not received previous systemic treatment, or have received previous (new) adjuvant treatment / radical treatment regimen (including radical surgical resection and radical chemoradiotherapy regimen) after recurrence for more than 6 months; Note: Including patients with reprogression after radiotherapy alone in late or recurrent non-target lesions. End of palliative treatment time to enrollment time of\> 2 weeks for local lesions (non-target lesions); 4. Have at least one measured lesion according to the efficacy evaluation criteria of solid tumors version RECIST 1.1; 5. Male or female patients between the ages of 18 and 75; 6. Physical condition (PS) score of Eastern Oncology Cooperative Group (ECOG): 0-1; 7. The survival period is expected to exceed 3 months; 8. Having adequate organ and bone marrow function, that is, meeting the following criteria: A) Routine blood test criteria required (14, no blood transfusion and blood products within days, no correction with G-CSF and other hematopoietic stimulating factors): Hemoglobin content (HB): 100g / L; Leukocyte content (WBC) 3.0\*10\^9 / L; Neutrophil count (ANC) 1.5\*10\^9 / L; Platelet count (PLT) of 75\*10\^9 / L. B) Biochemical examination shall meet the following standards: ...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: All of the following participants will be enrolled in this trial: 1. Patients voluntarily joined the study, signed informed consent, good compliance and follow-up. 2. unresectable locally advanced, unresectable recurrent or metastatic ESCC confirmed by histopathology (excluding mixed adenosquamous cell carcinoma type); 3. Patients who have not received previous systemic treatment, or have received previous (new) adjuvant treatment / radical treatment regimen (including radical surgical resection and radical chemoradiotherapy regimen) after recurrence for more than 6 months; Note: Including patients with reprogression after radiotherapy alone in late or recurrent non-target lesions. End of palliative treatment time to enrollment time of\> 2 weeks for local lesions (non-target lesions); 4. Have at least one measured lesion according to the efficacy evaluation criteria of solid tumors version RECIST 1.1; 5. Male or female patients between the ages of 18 and 75; 6. Physical condition (PS) score of Eastern Oncology Cooperative Group (ECOG): 0-1; 7. The survival period is expected to exceed 3 months; 8. Having adequate organ and bone marrow function, that is, meeting the following criteria: A) Routine blood test criteria required (14, no blood transfusion and blood products within days, no correction with G-CSF and other hematopoietic stimulating factors): Hemoglobin content (HB): 100g / L; Leukocyte content (WBC) 3.0\*10\^9 / L; Neutrophil count (ANC) 1.5\*10\^9 / L; Platelet count (PLT) of 75\*10\^9 / L. B) Biochemical examination shall meet the following standards: Total serum bilirubin (TBIL) 1.5 times the upper limit of normal (ULN); ALT and AST≤2.5ULN; ALT and LT AST 5 ULN; Cr≤1.5ULN Or creatinine clearance (CCr) 60 ml/min; (Cockcroft-Gault formula) C) Full coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) 1.5 times ULN; And d) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) low normal value (50%); E) myocardial zymogram: within the normal range. 9. Women of childbearing age should take appropriate contraceptive measures from screening to 3 months after the cessation of study treatment, and they must be non-lactating patients. Before starting administration, the pregnancy test was negative or no risk of pregnancy was demonstrated by meeting one of the following criteria: A) Postmenopause was defined as age greater than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; B) Women younger than 50 years old can also be considered postmenopausal if amenorrhea for 12 months or more after stopping all exogenous hormone therapy, and luteinizing hormone (LH) and follicular stimulating hormone (FSH) levels are within the range of laboratory postmenopausal reference values; And c) had ever undergone irreversible sterilization procedures, including hysterectomy, bilateral oophorectomy or bilateral tubal resection, except for bilateral tubal ligation. For men, give consent to appropriate contraception or surgical sterilization during the trial and 8 weeks after the last dose of trial drug; Exclusion Criteria: * 1\) Patients who have previously received treatment with anti EGFR monoclonal antibodies or any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; 2) Esophageal squamous cell carcinoma that tends to be completely obstructed under endoscopy and requires interventional treatment to relieve obstruction; 3) Patients with high risk of bleeding or perforation due to obvious invasion of adjacent organs (large arteries or trachea) of esophageal lesions by tumors, or patients who have already formed fistulas; 4) Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to enrollment; 5) There are multiple factors that can affect the use of therapeutic drugs, such as inability to swallow or chronic diarrhea or intestinal obstruction, significant impact on drug administration and absorption, or a known history of severe allergies to any of the study drug ingredients. 6\) Patients who have received traditional Chinese medicine anti-tumor treatment within the past 2 weeks (including medicinal herbs such as brucea, coix seed, polysaccharides from shiitake mushrooms, cantharides, toad skin, astragalus, Sophora flavescens, Polygonatum sibiricum, and Hedyotis chinensis), but have been taking traditional Chinese medicine anti-tumor treatment for more than 2 weeks are allowed to be enrolled; 7) The burden of liver metastases accounts for over 50% of the entire liver volume; 8) Patients with any severe and/or uncontrolled illnesses, including: 1. Patients with poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) using antihypertensive drugs; Or use two or more antihypertensive drugs to control blood pressure in patients; Patients who have previously experienced hypertensive crisis or hypertensive encephalopathy; 2. Patients with grade I or above myocardial ischemia or infarction, arrhythmia (including QTc interval greater than 450ms in males and greater than 470ms in females), and ≥ grade 2 congestive heart failure (NYHA classification), severe/unstable angina pectoris, as well as those who have undergone coronary/peripheral artery bypass surgery; 3. Active or uncontrolled severe infection (≥ CTCAE level 2 infection), known to have active pulmonary tuberculosis; 4. Renal failure requires hemodialysis or peritoneal dialysis 5. Liver diseases such as cirrhosis, decompensated liver disease, and chronic active hepatitis; 6. Poor control of diabetes (FBG\>10mmol/L); 7. Urine routine shows urinary protein ≥++and confirms 24-hour urinary protein quantification\>1.0 g; 9) Long term untreated wounds or fractures; 10) Known presence of symptomatic central nervous system metastases and/or cancerous meningitis; 11) Ascites with clinical significance, including any ascites that can be detected during physical examination, ascites that has been treated in the past or still requires treatment, and only those with imaging showing a small amount of ascites but no symptoms can be selected; 12) Patients with equal amounts of fluid accumulation in both pleural cavities, or a large amount of fluid accumulation in one pleural cavity, or those who have caused respiratory dysfunction and require drainage; 13) Suffering from interstitial lung disease that requires steroid hormone therapy; 14) Uncontrolled metabolic disorders or other non malignant tumor organs or systemic diseases or secondary reactions to cancer, which can lead to higher medical risks and/or uncertainty in survival evaluation; 15) Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 16) Individuals with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 17) History of other primary malignant tumors, except for the following: <!-- --> 1. Complete remission of malignant tumors for at least 2 years prior to enrollment and no need for additional treatment during the study period; 2. Non melanoma skin cancer or malignant freckle nevi that have been adequately treated and have no evidence of disease recurrence; 3. In situ cancer with sufficient treatment and no evidence of disease recurrence; 18) There is any history of immune related illness or treatment that: <!-- --> 1. Existence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; subjects with asthma requiring bronchodilators for medical intervention cannot be included); However, the following patients are allowed to be included: vitiligo, psoriasis, alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement treatment; 2. Diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy (prednisone or other therapeutic hormones at a dose\>10mg/day), and continued to be used within 2 weeks prior to the first dose; 3. Received any live vaccine, attenuated vaccine (including anti infective vaccines such as influenza vaccine, varicella vaccine, etc.) or inactivated vaccine within 4 weeks before enrollment, and planned to receive live vaccine/attenuated vaccine/inactivated vaccine during the study period; Used systemic immune stimulatory agents (including but not limited to interferon and IL-2) within 2 weeks prior to the start of the study treatment; 19) During pregnancy or lactation, 20) According to the researchers' judgment, there are accompanying diseases that pose a serious threat to patient safety or affect the completion of the study.

Treatments Being Tested

DRUG

Nimotuzumab

Combined chemotherapy phase Nimotuzumab 400mg,I.V.,D1,QW Maintenance treatment period:Until unbearable or PD Nimotuzumab 400mg,I.V.,D1,Q3W

DRUG

Sintilimab

Sintilimab 200mg,I.V.,D1,Q3W,Until unbearable or PD

DRUG

Paclitaxel-albumin

Paclitaxel-albumin 200 mg/m2,I.V.,D1,Q3W,4-6 Cycle

DRUG

Cisplatin

Cisplatin:75 mg/m2,I.V.,D1,Q3W,4-6 Cycle

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.

Feng Wang
Zhengzhou, Henan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06718205), the sponsor (The First Affiliated Hospital of Zhengzhou 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 NCT06718205 clinical trial studying?

This study is a prospective, single-arm, multicenter study. The patients were given chemotherapy with nimotuzumab and sindilimab. To analyze the efficacy and safety of nimotuzumab combined with sindilizumab and chemotherapy in first-line treatment of advanced or recurrent or metastatic esophageal cancer. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06718205?

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 NCT06718205?

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 NCT06718205. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06718205. 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.