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Esophageal CancerPhase 3NCT06501664

Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC

A Phase 3 study testing liposomal irinotecan, 5-FU and LV in people with Esophageal Cancer, run by Rui-hua Xu, MD, PhD.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan / irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
liposomal irinotecan, 5-FU and LV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
No sites listed yet
Study dates
1 Aug 2024to 30 Nov 2027
Phase
Phase 3
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

  • Age: 18-75 years old.
  • Unresectable esophageal squamous cell carcinoma confirmed by histopathology and/or cytology.
  • Failure or intolerance to first-line treatment.
  • At least one measurable lesion (according to RECIST v1.1).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1.
  • The expected survival time ≥3 months.
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  • Subject has adequate biological parameters as demonstrated by the following: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin (Hgb) ≥90 g/L.
  • Adequate hepatic function as evidenced by total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN, ≤5 x ULN if liver metastases are present. Documented serum albumin ≥ 3 g/dL.
  • Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 x ULN or creatinine clearance ≥60 mL/min.
  • Subjects agree to use contraception and are not pregnant or breastfeeding women.
  • Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.

Who cannot join

  • Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma.
  • Received irinotecan/irinotecan liposome based therapy in the first line.
  • Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
  • Active HIV infection.
  • Combined with uncontrollable systemic diseases, such as unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, severe pericardial disease history and other cardiovascular diseases; uncontrolled hypertension(Defined as systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90 mmHg after treatment with standardized antihypertensive drugs), or history of critical hypertension, hypertensive encephalopathy; uncontrollable diabetes, etc.
  • Presence of severe gastrointestinal disease (including active bleeding, > grade 1 obstruction , > grade 1 diarrhea or gastrointestinal perforation)
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  • Allergy to or intolerance to therapeutic drugs or their excipients.
  • Presence of central nervous system metastasis.
  • Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
  • Participated in other trial within 30 days or within 5 half-lives of the drug prior to the first dose of study treatment.
  • Patients who are not suitable to participate in this trial for any reason judged by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Huiyan Luo, Professor contact

020-87343804

luohy@sysucc.org.cn

About this study

Official title: Liposomal Irinotecan and 5-FU Versus Irinotecan / Irinotecan+5-fluorouracil as Second-line Therapy for Patients With Esophageal Squamous Cell Carcinoma: A Open-label, Randomized Study

The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan / irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).

Read the detailed description

Esophageal cancer was ranked the sixth most common cancer worldwide and seventh most common cause of cancer-related deaths. ESCC is the most common histologic subtype in Asia. The National Comprehensive Cancer Network (NCCN) guidelines recommend immune checkpoint inhibitors, taxanes, fluorouracils and/or irinotecan as the second-line treatment of ESCC. Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose, improve the efficacy and reduce the toxic side effects. The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan / irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).

Being tested
liposomal irinotecan, 5-FU, LV, Irinotecan
Keywords
liposomal irinotecan, second-line therapy, esophageal squamous cell carcinoma
Medical subject headings
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • liposomal irinotecanDrug

    Also called Nal-IRI

    Liposomal irinotecan 70 mg/m²

  • 5-FUDrug

    Also called Fluorouracil

    5-FU 400 mg/m² bolus then 2400 mg/m2 over 46 h

  • LVDrug

    Also called Calcium folinate

    LV 400 mg/m²

  • IrinotecanDrug

    Also called IRI

    Irinotecan 180 mg/m²

Study groups in NCT06501664
Study groupRoleWhat they receive
Experimental GroupExperimentalliposomal irinotecan+5-FU/LV q2w
Receives: Drug: liposomal irinotecan; Drug: 5-FU; Drug: LV
Control groupActive comparatorIrinotecan q2w or irinotecan+5-FU/LV q2w
Receives: Drug: 5-FU; Drug: LV; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Defined as the time between the date of randomization and death due to various causes

    Measured: 1 year

Secondary outcomes (4)

  1. Objective Response Rate

    Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1

    Measured: 4 months

  2. Disease Control Rate

    Defined as the percentage of patients who achieved CR, PR, and stable disease (SD) according to RECIST v1.1

    Measured: 4 months

  3. Progress-free survival

    Defined as time from the date of randomization to first documented disease progression using RECIST version 1.1 by investigator review or death due to any cause, whichever occurred first.

    Measured: 5 months

  4. Incidence of adverse events

    Use NCI-CTCAE version 5.0 for classification and grading

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06501664
Sponsor's protocol ID
CSPC-DEY-ESCC-K01
Status last verified
Jul 2024
First submitted
9 Jul 2024
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liposomal irinotecan, 5-FU and LV in people with Esophageal Cancer, run by Rui-hua Xu, MD, PhD.

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 11 inclusion and 11 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 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Huiyan Luo, Professor (020-87343804, luohy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06501664.

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 15 Jul 2024.

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