CClinicalTrials.gg
Status unknownNCT05381636Updated May 19, 2022

Esophageal Arterial Infusion Chemotherapy Versus Systemic Intravenous Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Multicentre, Randomised Controlled Clinical Study

A Phase 2 interventional study of Esophageal arterial infusion chemotherapy and Systemic intravenous chemotherapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma, sponsored by The First Affiliated Hospital of Zhengzhou University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-19.

Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This was a prospective, multicentre, randomised controlled clinical study to explore the safety and efficacy of esophageal arterial infusion chemotherapy in patients with resectable locally advanced oesophageal cancer, and to compare its safety and efficacy with systemic intravenous chemotherapy. The rate of surgical R0 resection as well as progression free survival (PFS) were the main indicators.

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Conditions studied

  • Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 120 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 123 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Sign written informed consent prior to the implementation of any test related procedures; 2. Aged 18-75 years; 3. Histopathological examination confirmed resectable esophageal carcinoma (histologically, squamous cell carcinoma), without esophageal/gastric junction adenocarcinoma; 4. Before surgery, CT/MRI, color ultrasound, PET-CT, and ultrasonic gastroscopy were used to clearly diagnose esophageal cancer staging as >= CT3 or >=N+; 5. Newly diagnosed patients without previous surgery, radiotherapy or chemotherapy, targeted therapy or immunotherapy; 6. ECOG score ≤2,KPS ≥60%; 7. No serious heart, lung or liver dysfunction; No acute infection was associated; 8. No participation in other clinical studies within 3 months prior to treatment; 9. Sufficient organ function, subject should meet the following laboratory criteria:

      1. The absolute value of neutrophils (ANC) ≥1.5x10\^9/L in the last 14 days without the use of granulocyte colony-stimulating factor;
      2. Platelets ≥80x10\^9/L in the case of no blood transfusion in the last 14 days;
      3. Hemoglobin ≥80g/dL in the absence of blood transfusion or use of erythropoietin in the last 14 days;
      4. Total bilirubin ≤1.5 ULN; Or total bilirubin >ULN but direct bilirubin ≤ULN;
      5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ULN (ALT or AST≤5 ULN are allowed in patients with liver metastasis);
      6. Serum creatinine ≤1.5 ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥60ml/min;
      7. Good coagulation function, defined as INR or prothrombin time (PT) ≤1.5 ULN;
      8. Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is beyond the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can be included;
      9. Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judged that it is a simple laboratory abnormality without clinical significance, it is also allowed to be enrolled); 10. For female subjects of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (cycle 1 day 1). If a urine pregnancy test cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age were defined as at least 1 year postmenopausal or having undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects (both men and women) should use contraceptives with an annual failure rate of less than 1% throughout the treatment period and up to 1 year after the last study dosing.

Exclusion criteria

Exclusion Criteria:

    1. Previous operation history of thoracic malignant tumor; 2. Pathologically small cell carcinoma or distant metastasis; Patients with tumor involvement of the cervical esophagus or high upper thoracic segment requiring laryngectomy; 3. Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg); 4. Patients at high risk of bleeding or perforation due to tumor invasion of an adjacent organ of the esophageal lesion (aorta or trachea), or patients with fistula; 5. Other malignant diseases other than esophageal cancer diagnosed within 5 years prior to initial administration (excluding basal cell carcinoma of the skin after radical resection, squamous carcinoma of the skin, and/or carcinoma in situ after radical resection); 6. Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to the first administration; 7. Received Chinese patent drugs with anti-tumor indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for local use of pleural effusion control) within 2 weeks before the first administration; 8. Known interstitial pulmonary disease requiring steroid therapy, active pulmonary tuberculosis, active autoimmune disease requiring systemic therapy (e.g., use of palliative drugs, glucocorticoids, or immunosuppressants) developed within 2 years prior to initial administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment; 9. The study was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days prior to initial administration; Note: Physiological dose of glucocorticoids (≤10mg/ day of prednisone or equivalent drug) is allowed; 10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. People who are known to be allergic to the active ingredients or exciphers of the drugs in this study, such as cisplatin, cisplatin, or albu-paclitaxel; 12. A known history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive); 13. The presence of any serious or uncontrollable systemic disease, such as:

      1. There are significant abnormalities in rhythm, conduction or morphology of the resting electrocardiogram with serious symptoms that are difficult to control, such as complete left bundle branch block, heart block above II degree, ventricular arrhythmia or atrial fibrillation;
      2. Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥2 chronic heart failure;
      3. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before inclusion;
      4. A history of non-infectious pneumonia requiring glucocorticoid therapy or current clinically active interstitial lung disease within 1 year prior to initial administration;
      5. active tuberculosis;
      6. the presence of active or uncontrolled infections requiring systemic treatment;
      7. Clinical active diverticulitis, abdominal abscess and gastrointestinal obstruction;
      8. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
      9. Poor control of diabetes mellitus (FBG > 14mmol/L);
      10. Routine urine indicated urinary protein ≥++, and confirmed 24-hour urinary protein quantitative > 1.0g;
      11. Patients with mental disorders who are unable to cooperate with treatment; Medical history or evidence of disease that may interfere with the outcome of the study, prevent participants from participating in the study, abnormal therapeutic or laboratory test values, or other conditions that the investigator considers unsuitable for inclusion.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Control group

    Systemic intravenous chemotherapy with albumin paclitaxel 125 mg / m2 for D1, D8 + cisplatin 75 mg / m2 for D1, every 3 weeks for 1 cycle

    Drug: Systemic intravenous chemotherapy

  • Experimental
    Study group

    esophageal arterial infusion chemotherapy

    Procedure: Esophageal arterial infusion chemotherapy

Interventions

  • ProcedureEsophageal arterial infusion chemotherapy

    Percutaneous femoral artery puncture was performed to search for feeding arterial vessels corresponding to the lesion, and chemotherapeutic drugs were directly injected into the tumor vessels via targeted blood vessels.

  • DrugSystemic intravenous chemotherapy

    Albumin paclitaxel 125 mg / m2, D1, D8 + cisplatin 75 mg / m2, D1, every 3 weeks for 1 cycle

06

What researchers measure

Primary outcomes

  1. Surgical R0 resection rate

    Time frame: up to 1 year

  2. Progression free survival (PFS)

    PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

    Time frame: up to 1 year

Secondary outcomes

  1. Pathological complete response rate(PCRR)

    Time frame: up to 1 year

  2. Objective response rate(ORR)

    ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria.

    Time frame: up to 1 year

  3. Treatment related AES

    Time frame: up to 1 year

  4. Overall survival (OS)

    The time from recruitment to death due to any cause.

    Time frame: up to 1 year

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05381636
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Responsible party
Gang Wu (Chief physician, The First Affiliated Hospital of Zhengzhou University) — Principal investigator
First posted
May 19, 2022
Start date
Jun 1, 2022 (estimated)
Primary completion
Jun 1, 2023 (estimated)
Completion
May 31, 2024 (estimated)
Last update
May 19, 2022

Study contacts

Gang Wu, MD
Contact
wuganghenan2015@163.com
+86 13938570175

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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