A Randomized, Double-blind,Phase Ⅲ Study of Liposome Doxorubicin in Desmoid Tumor

NCT05561036 | Unknown Phase 3

• 1 other identifier: B2020-067-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the efficacy and safety of liposomal doxorubicin in the treatment of desmoid tumors. Unless the subject withdraws from the trial voluntarily, or the researcher considers that the subject is not suitable for further trial, each subject will be treated until the disease progresses or the toxic and side effects caused by the drug are intolerable, and then enter the survival follow-up period

Conditions

Desmoid Tumor

Keywords

liposome doxorubicin; Desmoid Tumor

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression Free Survival Rate

  24 months

Secondary Outcomes (2)

• ORR

  24 months

• Patient Reported Outcomes-Common Terminology Criteria in Adverse Events version 5.0

  24 months

Study Arms (2)

Liposome doxorubicin

EXPERIMENTAL

Liposome doxorubicin (50mg/m2) with a treatment cycle of once every 28 days

Drug: Liposome doxorubicin

intravenous placebo

PLACEBO COMPARATOR

saline solution

Drug: Saline Solution

Interventions

Liposome doxorubicin DRUG

Liposome doxorubicin (50mg/m2) or intravenous placebo with a treatment cycle of once every 28 days

Also known as: liposome adriamycin

Liposome doxorubicin

Saline Solution DRUG

saline solution

intravenous placebo

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be confirmed as desmoid tumor by histopathology
• Patients should have measurable lesions defined by RECIST v1.1
• One of the following conditions is satisfied
• The disease should be defined as non resectable or tumor with disability after resection. The definition standard should meet one or more of the following characteristics
• Multiple lesions
• The disease has involved or does not have enough blood vessel nerve bundle, bone, skin and fascia resection boundary
• Large tumor or multiple chambers involved
• Imaging showed progress (increased by 10% according to RECIST v1.1 standard size within 6 months before enrollment)
• The BPI score of patients with symptomatic diseases was more than 3 points and met one of the following conditions:
• NSAIDs can not control pain, and consider increasing the control of narcotic drugs
• Current use of narcotic drugs increased by 30%
• New opioid anesthetics needed
• Patients are allowed to receive chemotherapy, biological (antibody) therapy, immuno or experimental therapy, tyrosine kinase inhibitors, hormone therapy or NSAIDs treatment, provided that the treatment is completed at least 4 weeks before enrollment (6 weeks of mitomycin and nitrosourea treatment) and recovers from any treatment-related toxicity below CTCAE Level 2
• Age ≥ 1 year old, male or female
• ECoG score ≤ 2

You may not qualify if:

• Pregnant and lactating women, or fertile women who are not willing to take effective contraceptive measures during the study period
• Those who are known to be allergic to liposome doxorubicin or any component of doxorubicin, or have a history of allergy or hypersensitivity to any therapeutic component or structural analogue in this study
• Subjects previously treated with liposomal doxorubicin
• Patients who have used doxorubicin or epirubicin for more than 450 mg / m2 or more than 550 mg / m2 for epirubicin or anthracycline for heart disease
• The subjects did not receive any other drugs or anti-cancer therapy in the study
• It needs to be combined with other anti-tumor drugs
• Combined with diseases that may affect the subject's condition or ability to conduct the test, or reduce compliance, including but not limited to the following diseases:
• A:Patients with active gastrointestinal bleeding, such as active peptic ulcer, ulcerative enteritis, or Crohn's disease B:Severe cardiac history: congestive heart failure \> NYHA grade II; active coronary heart disease (CAD) (myocardial infarction or unstable angina pectoris, cerebrovascular disease patients within 6 months before the start of the study; uncontrolled hypertension (systolic blood pressure greater than 150 mmHg and / or diastolic blood pressure greater than 100 after combination of two or more antihypertensive drugs) MmHg) and history of hypertensive crisis or hypertensive encephalopathy C:Severe liver and kidney disease, serum ast, ALT more than 2 times the upper limit of the normal range, or Cr more than the upper limit of the normal range, total bilirubin \> 1.5 times the upper limit of the normal value, patients with liver metastasis, AST and ALT \> 5.0 times the upper limit of normal value D:Serious endocrine diseases, uncontrolled diabetes, blood disease, neuropsychiatric disease patients E:Patients with severe immunosuppression or long-term use of corticosteroids or immunosuppressants are known F:Active hemoptysis G:Symptomatic bacterial, fungal or viral infections, including but not limited to HIV, syphilis, or HBV or HCV infection
• Patients who have used other test drugs or devices or participated in other clinical trials within 3 months before the start of this trial
• Patients who were considered unsuitable for the trial due to other reasons

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University cancer center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Jin Wang, M.D.

CONTACT

020-87343910; wangjin@sysucc.org.cn

Huaiyuan Xu, M.D.

CONTACT

020-87340519; xuhy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician Professor

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: September 30, 2022
• Study Start: September 29, 2020
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)