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A Study of Irinotecan Hydrochloride Liposome in Combination With 5-FU/LV in Advanced Solid Tumors

NCT ID: NCT05086848

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-05

Study Completion Date

2018-06-06

Brief Summary

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This is a dose-escalation and expansion, open label, single centre, phase Ib study. In this study, the tolerability, safety, pharmacokinetics and efficacy of irinotecan hydrochloride liposome injection in combination with 5-FU/LV were studied in patients with advanced solid tumors. Meanwhile, to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan hydrochloride liposome.

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

a dose-escalation and expansion study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group:

Irinotecan liposome plus 5-fluorouracil, Leucovorin

Group Type EXPERIMENTAL

Irinotecan liposome、5-fluorouracil、Leucovorin

Intervention Type DRUG

Irinotecan liposome、5-fluorouracil、Leucovorin

Interventions

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Irinotecan liposome、5-fluorouracil、Leucovorin

Irinotecan liposome、5-fluorouracil、Leucovorin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histologically or cytologically confirmed solid tumors documented as advanced or metastatic disease;
2. Subjects must be considered relapsed or refractory to standard therapies, have been intolerant to standard therapies, or have refused standard therapy;
3. ECOG: 0-1;
4. Adequate organ and bone marrow function;
5. sign an informed consent.

Exclusion Criteria

1. Patients with brain malignant tumor or active CNS metastasis;
2. UGT1A1\*28 homozygous mutants;
3. Clinically significant GI disorders;
4. Significant cardiovascular disease;
5. Active infection or uncontrolled fever;
6. Pregnant or breast feeding patients;
7. Allergic to a drug ingredient or component;
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Ji D, Shen W, Li T, Wang H, Bai J, Cao J, Hu X. Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study. Invest New Drugs. 2024 Aug;42(4):462-470. doi: 10.1007/s10637-024-01442-2. Epub 2024 Jul 22.

Reference Type DERIVED
PMID: 39037543 (View on PubMed)

Other Identifiers

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YLTKL-Ib

Identifier Type: -

Identifier Source: org_study_id