Esophageal Squamous Cell CarcinomaPhase 1NCT06491134
Liposomal Irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 1 study testing Liposomal Irinotecan Hydrochloride in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital.
Trial summary
Observation of maximum tolerable dose (MTD), dose limiting toxicity (DLT), and phase II clinical recommended dose (RP2D) of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Liposomal Irinotecan Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2024to 28 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Understand and be willing to sign written informed consent and be able to follow research protocols for treatment.
- Age 18-75 years.
- Histologically confirmed cT2-T4a,N0-N+,M0 Esophageal Squamous Carcinoma.
- Existence of measurable and/or unmeasurable lesions that meet the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
- No previous anti-tumor therapy for esophageal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
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- Life expectancy ≥ 3months
- Adequate organ and bone marrow function measured within14 days prior to administration of study treatment as defined below:
- Haemoglobin ≥ 90g/dL Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Total bilirubin ≤institutional upper limit of normal Aspartate aminotransferase (AST(SGOT)/Alanine transaminase (ALT)SGPT) ≤ 2.5 x institutional upper limit of normal Serum creatinine ≤ 1.2mg/dL And creatinine clearance ≥50mL/min (Cockcroft-Gault formula)
- Women who are not pregnant or lactating. During the study period and within 6 months of the end of the study treatment, childbearing age Women/men should take effective contraceptive measures.
Who cannot join
- patients with other malignant tumors within the previous 5 years, except for cure carcinoma in situ, skin basal cell carcinoma.
- Allergic to cisplatin.
- Patients with a history of esophageal squamous cell carcinoma surgery.
- A history of fistula caused by primary tumor infiltration.
- Have higher, esophageal fistula or esophageal perforation of gastrointestinal bleeding risk.
- Poor nutritional status, BMI < 18.5kg/m2, or PG-SGA score ≥9.
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- Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment.
- Patients with active hepatitis B, hepatitis C, syphilis.
- major cardiovascular disease, including any of the following:
- Within 6 months before enrollment, congestive heart failure (defined as New York Heart Association grade III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass grafting, cerebrovascular accident, or hypertensive crisis.
- A history of clinically significant ventricular arrhythmias
- Friderica-modified QT interval >450 msec in men and >470 msec in women
- History of congenital long QT syndrome or family history
- Arrhythmias requiring antiarrhythmic drug therapy
- History of deep vein thrombosis, pulmonary embolism, or any other major thromboembolism within 3 months before enrollment
- Severe prolonged diarrhoea.
- Severe mental illness.
- Use of strong inhibitors or inducers such as CYP3A4, CYP2C8 and UGT1A1.
- Participate in other trials within 4 weeks before the start of the trial.
- The investigators believe that patients were inappropriate for participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase Ib Trial of Liposomal Irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
Observation of maximum tolerable dose (MTD), dose limiting toxicity (DLT), and phase II clinical recommended dose (RP2D) of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal squamous cell carcinoma. Evaluate the efficacy and safety of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Liposomal Irinotecan Hydrochloride
- Keywords
- liposomal irinotecan, Cisplatin, Radiotherapy, Locally Advanced Esophageal squamous cell carcinoma
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Irinotecan HydrochlorideDrug
liposomal irinotecan With Cisplatin and Concurrent Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| liposomal irinotecan | Experimental | liposomal irinotecan With Cisplatin and Concurrent Radiotherapy Receives: Drug: Liposomal Irinotecan Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerable dose (MTD)
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing dose-limiting
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR
Measured: Within 28 days of the end of treatment
Progress-free survival(PFS)
Progression-free survival will be measured from the start of treatment until the first documentation of confirmed disease progression or death due to any cause, whichever occurs first.
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start27 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun wang, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491134
- Sponsor's protocol ID
- HESS-LAEC-202401
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Trial of Liposomal Irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06491134
- Acronym / sponsor ID
- HESS-LAEC-202401
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- liposomal irinotecan, Cisplatin, Radiotherapy, Locally Advanced Esophageal squamous cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 27 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 8 Jul 2024 (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.
Observation of maximum tolerable dose (MTD), dose limiting toxicity (DLT), and phase II clinical recommended dose (RP2D) of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal squamous cell carcinoma. Evaluate the efficacy and safety of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liposomal irinotecan | Experimental | Drug: Liposomal Irinotecan Hydrochlorideliposomal irinotecan With Cisplatin and Concurrent Radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Understand and be willing to sign written informed consent and be able to follow research protocols for treatment.
- Age 18-75 years.
- Histologically confirmed cT2-T4a,N0-N+,M0 Esophageal Squamous Carcinoma.
- Existence of measurable and/or unmeasurable lesions that meet the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
- No previous anti-tumor therapy for esophageal cancer
Key exclusion criteria (20 listed)
- patients with other malignant tumors within the previous 5 years, except for cure carcinoma in situ, skin basal cell carcinoma.
- Allergic to cisplatin.
- Patients with a history of esophageal squamous cell carcinoma surgery.
- A history of fistula caused by primary tumor infiltration.
- Have higher, esophageal fistula or esophageal perforation of gastrointestinal bleeding risk.
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 |
|---|---|---|
| Liposomal Irinotecan Hydrochlorideliposomal irinotecan With Cisplatin and Concurrent Radiotherapy | Drug | liposomal irinotecan |
Primary outcome
maximum tolerable dose (MTD)
Time frame: through study completion, an average of 1 year
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing dose-limiting
2 secondary outcomes
Objective response rate (ORR)
Time frame: Within 28 days of the end of treatment
Progress-free survival(PFS)
Time frame: 2-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposomal Irinotecan Hydrochloride in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital.
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 20 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: opening soon, as of the sponsor's last update on 8 Jul 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Wang, Phd (13931182128, wangjunzr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerable dose (MTD) (time frame: through study completion, an average of 1 year). 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 8 Jul 2024.