A Prospective, Single-arm Clinical Study of Liposomal Mitoxantrone Combination Regimen in the Treatment of Relapsed and Refractory Solid Tumors in Children, Adolescents and Young Adults

NCT06761417 | Not Yet Recruiting Phase 2

• 1 other identifier: NCC5006
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical study is to determine the efficacy and safety of the liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors among children, adolescents, and young adults. The key questions it intends to address are: Can the liposomal mitoxantrone combination regimen improve the objective response rate (ORR) compared to historical data? What are the adverse events associated with this combination regimen? Researchers will administer the liposomal mitoxantrone combination regimen (including capecitabine and anlotinib with specific dosing regimens) to the participants and closely monitor their conditions. Participants will: Receive the treatment regimen for 4 - 6 cycles, with each cycle lasting 21 days Undergo regular checkups and tests during the treatment period and follow-up period as per the protocol. Have their tumor status, blood parameters, and other relevant indicators measured to evaluate the treatment effect and safety.

Conditions

Solid Tumors; Children; Adolescents

Keywords

Mitoxantrone liposomes; Solid tumor; Children and adolescents

Outcome Measures

Primary Outcomes (1)

• Rate of Objective response(ORR)

  Rate of Objective response (ORR) after 4 or 6 cycles of Liposomal Mitoxantrone Combination Regimen, including complete response (CR) and partial response (PR)

  Up to 6 cycles of chemotherapy (each cycle is 21 days)

Secondary Outcomes (5)

• Rate of Disease control (DCR)

  Up to 6 cycles of Liposomal Mitoxantrone Combination Regimen (each cycle is 21 days)

• Progression-free survival (PFS)

  From date of enrollment unit the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

• Overall survival (OS)

  From date of enrollment unit the date of first documented date of death from any cause, assessed up to 24 months.

• Proportion of patients eligible for local treatment after treatment

  Up to 6 cycles of chemotherapy (each cycle is 21 days)

• Safty

  After signing the informed consent form, the safety monitoring began and continued until the end of the follow-up (follow-up period of 1 year).

Study Arms (1)

Liposomal Mitoxantrone Combination Regimen

EXPERIMENTAL

Mitoxantrone liposome+Capecitabine+Anlotinib

Drug: Mitoxantrone liposome; Drug: Capecitabine; Drug: Anlotinib

Interventions

Mitoxantrone liposome DRUG

Mitoxantrone liposome: 16 mg/m\^2, d1; Each 21-day cycle was used for a total of 4-6 cycles.

Liposomal Mitoxantrone Combination Regimen

Capecitabine DRUG

Capecitabine 1000 mg/m\^2, d1-14, bid; Each 21-day cycle was used for a total of 4-6 cycles.

Liposomal Mitoxantrone Combination Regimen

Anlotinib DRUG

Anlotinib: according to patient weight: 8mg/ day in patients \<35kg; 10mg/ day for patients with 35kg≤ patient weight ≤50kg; 12mg/ day for patients \> 50kg; d1-14; Each 21-day cycle was used for a total of 4-6 cycles.

Liposomal Mitoxantrone Combination Regimen

Eligibility Criteria

• Age: 6 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The patient fully understands this study, voluntarily participates and signs the informed consent form (ICF).
• Age: children (6 - 12 years old), adolescents (13 - 18 years old) and young adults (19 - 24 years old) (CAYA). The expected survival time is \> 3 months.
• Diagnosed with relapsed and refractory solid tumors by histopathology, and it is one of the following subtypes: (1) bone and soft tissue tumors; (2) neuroblastoma; (3) other types of solid tumors that the investigator deems eligible for enrollment.
• There must be measurable tumor lesions by CT, enhanced CT, PET/CT or MRI.
• Karnofsky score \> 50; ECOG score ≤ 2.
• Bone marrow function: neutrophil count \> 1.5 × 10⁹/L, platelet count \> 75 × 10⁹/L, hemoglobin ≥ 80 g/L.
• Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT \< 2.5 times the upper limit of normal value (for patients with liver invasion \< 5 times the upper limit of normal value); total bilirubin \< 1.5 times the upper limit of normal value (for patients with liver invasion \< 3 times the upper limit of normal value).
• No history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, no history of clinically severe pericardial disease, or no electrocardiogram evidence of acute ischemic or active conduction system abnormality within 6 months before recruitment.

You may not qualify if:

• Patients with known hypersensitivity to any component of the study drugs.
• Patients with other malignant tumors that are not under control (except for basal cell carcinoma of the skin, in-situ breast/cervical cancer, and other malignant tumors that have been effectively controlled without treatment in the past five years).
• Pregnant, lactating women and women of childbearing age who are unwilling to take contraceptive measures.
• Other situations judged by the investigator as not suitable for participating in this study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Interventions

Capecitabine; anlotinib

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Sidan Li

CONTACT

+86-0316-5917421; lisidan2006@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: It is expected to enroll 49 patients with relapsed and refractory solid tumors in children, adolescents and young adults. The treatment will be carried out using the liposomal mitoxantrone combination regimen. The minimum acceptable objective response rate (ORR) is 30%, and the expected ORR is 50%. The study includes a screening period (within 28 days), a treatment period (planned for 6 cycles), and a follow-up period (safety follow-up and progression-free survival (PFS) follow-up). Subjects who sign the informed consent form and undergo baseline examinations within the screening period, and those who meet the inclusion and exclusion criteria will enter the treatment period, with one cycle every 3 weeks. All subjects will complete the relevant examinations specified in the protocol during the treatment process to observe the safety and efficacy. After the treatment period, they will enter the follow-up period.

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 7, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)