Resectable Locally Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT05381636
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 study testing Esophageal arterial infusion chemotherapy and Systemic intravenous chemotherapy in people with Resectable Locally Advanced Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- Esophageal arterial infusion chemotherapy and Systemic intravenous chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 31 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- The absolute value of neutrophils (ANC) ≥1.5x10^9/L in the last 14 days without the use of granulocyte colony-stimulating factor;
- Platelets ≥80x10^9/L in the case of no blood transfusion in the last 14 days;
- Hemoglobin ≥80g/dL in the absence of blood transfusion or use of erythropoietin in the last 14 days;
- Total bilirubin ≤1.5 ULN; Or total bilirubin >ULN but direct bilirubin ≤ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ULN (ALT or AST≤5 ULN are allowed in patients with liver metastasis);
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- Serum creatinine ≤1.5 ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥60ml/min;
- Good coagulation function, defined as INR or prothrombin time (PT) ≤1.5 ULN;
- 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;
- 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.
Who cannot join
- 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:
- 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;
- Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥2 chronic heart failure;
- 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;
- A history of non-infectious pneumonia requiring glucocorticoid therapy or current clinically active interstitial lung disease within 1 year prior to initial administration;
- active tuberculosis;
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- the presence of active or uncontrolled infections requiring systemic treatment;
- Clinical active diverticulitis, abdominal abscess and gastrointestinal obstruction;
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- Poor control of diabetes mellitus (FBG > 14mmol/L);
- Routine urine indicated urinary protein ≥++, and confirmed 24-hour urinary protein quantitative > 1.0g;
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Esophageal arterial infusion chemotherapy, Systemic intravenous chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal arterial infusion chemotherapyProcedure or surgery
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.
Systemic intravenous chemotherapyDrug
Albumin paclitaxel 125 mg / m2, D1, D8 + cisplatin 75 mg / m2, D1, every 3 weeks for 1 cycle
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Systemic intravenous chemotherapy with albumin paclitaxel 125 mg / m2 for D1, D8 + cisplatin 75 mg / m2 for D1, every 3 weeks for 1 cycle Receives: Drug: Systemic intravenous chemotherapy |
| Study group | Experimental | esophageal arterial infusion chemotherapy Receives: Procedure: Esophageal arterial infusion chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical R0 resection rate
Measured: up to 1 year
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.
Measured: up to 1 year
Secondary outcomes (4)
Pathological complete response rate(PCRR)
Measured: up to 1 year
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.
Measured: up to 1 year
Treatment related AES
Measured: up to 1 year
Overall survival (OS)
The time from recruitment to death due to any cause.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Locally Advanced Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wu, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381636
- Sponsor's protocol ID
- ESCC-2022-06
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Arterial Infusion Chemotherapy Versus Systemic Intravenous Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Prospective, Multicentre, Randomised Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05381636
- Acronym / sponsor ID
- ESCC-2022-06
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Systemic intravenous chemotherapySystemic intravenous chemotherapy with albumin paclitaxel 125 mg / m2 for D1, D8 + cisplatin 75 mg / m2 for D1, every 3 weeks for 1 cycle |
| Study group | Experimental | Procedure: Esophageal arterial infusion chemotherapyesophageal arterial infusion chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal arterial infusion chemotherapyPercutaneous 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. | Procedure or surgery | Study group |
| Systemic intravenous chemotherapyAlbumin paclitaxel 125 mg / m2, D1, D8 + cisplatin 75 mg / m2, D1, every 3 weeks for 1 cycle | Drug | Control group |
Primary outcome
Surgical R0 resection rate
Time frame: up to 1 year
Progression free survival (PFS)
Time frame: up to 1 year
PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
4 secondary outcomes
Pathological complete response rate(PCRR)
Time frame: up to 1 year
Objective response rate(ORR)
Time frame: up to 1 year
Treatment related AES
Time frame: up to 1 year
Overall survival (OS)
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esophageal arterial infusion chemotherapy and Systemic intravenous chemotherapy in people with Resectable Locally Advanced Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Wu, MD (+86 13938570175, wuganghenan2015@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical R0 resection rate (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.