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

ConditionEsophageal Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRui-hua Xu, MD, PhD

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • liposomal irinotecan

    Drug

    Liposomal irinotecan 70 mg/m²

  • 5-FU

    Drug

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

  • LV

    Drug

    LV 400 mg/m²

  • Irinotecan

    Drug

    Irinotecan 180 mg/m²

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 3 interventions
Group B: Control groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Overall survival

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

Time frame
1 year

Secondary outcomes

1

Objective Response Rate

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

Time frame
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

Time frame
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.

Time frame
5 months
4

Incidence of adverse events

Use NCI-CTCAE version 5.0 for classification and grading

Time frame
5 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rui-hua Xu, MD, PhD

Lead sponsor

Sun Yat-sen University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: