Solid TumorsPhase 2NCT06761417
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
A Phase 2 study testing Mitoxantrone liposome, Capecitabine and Anlotinib in people with Solid Tumors and Children, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 years
- Conditions the study is for
- Solid Tumors, Children, Adolescents
- What is being tested?
- Mitoxantrone liposome, Capecitabine and Anlotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2025to 1 Feb 2028
- Phase
- Phase 2
- 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 6 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Main inclusion Criteria:
- 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.
Main exclusion Criteria:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Sidan Li, 01087788559, lisidan2006@126.com
About this study
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.
Read more
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.
Read the detailed description
This is a prospective, single-arm, multicenter clinical study named "A Prospective, Single-arm, Multicenter Clinical Study of Liposomal Mitoxantrone Combination Regimen in the Treatment of Relapsed and Refractory Solid Tumors in Children, Adolescents and Young Adults". The study aims to assess the safety and effectiveness of the liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors among children, adolescents, and young adults.
The research anticipates enrolling 49 patients meeting specific criteria. The inclusion criteria require patients to have a clear understanding of the study, sign the informed consent form voluntarily, fall within the age range of 6 - 24 years with an expected survival time exceeding 3 months, have histopathologically confirmed relapsed and refractory solid tumors of certain subtypes (such as bone and soft tissue tumors, neuroblastoma, etc.), possess measurable tumor lesions detectable by CT, enhanced CT, PET/CT or MRI, and meet specific Karnofsky and ECOG scores as well as requirements for bone marrow, liver, and kidney functions. Exclusion criteria cover those with hypersensitivity to study drugs, uncontrolled other malignancies, pregnant or lactating women, and those judged unsuitable by investigators.
The treatment regimen consists of capecitabine at a dose of 1000 mg/m² from day 1 to 14, twice daily, and anlotinib with the dose adjusted according to body weight for 14 days, with a 21-day cycle repeated 4 - 6 times. Patients achieving a partial response or better will undergo local treatment like surgery or radiotherapy.
The primary endpoint of the study is the objective response rate (ORR), while secondary endpoints include the proportion of patients eligible for local treatment after treatment, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse events evaluated by NCI CTCAE v5.0. This study holds great significance for exploring new treatment options for relapsed and refractory solid tumors in the target population.
- Conditions
- Solid Tumors, Children, Adolescents
- Being tested
- Mitoxantrone liposome, Capecitabine, Anlotinib
- Keywords
- Mitoxantrone liposomes, Solid tumor, Children and adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone liposomeDrug
Mitoxantrone liposome: 16 mg/m^2, d1; Each 21-day cycle was used for a total of 4-6 cycles.
CapecitabineDrug
Capecitabine 1000 mg/m^2, d1-14, bid; Each 21-day cycle was used for a total of 4-6 cycles.
AnlotinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Mitoxantrone Combination Regimen | Experimental | Mitoxantrone liposome+Capecitabine+Anlotinib Receives: Drug: Mitoxantrone liposome; Drug: Capecitabine; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 6 cycles of chemotherapy (each cycle is 21 days)
Secondary outcomes (5)
Rate of Disease control (DCR)
Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy
Measured: Up to 6 cycles of Liposomal Mitoxantrone Combination Regimen (each cycle is 21 days)
Progression-free survival (PFS)
Means from the date of enrollment to the date of first disease progression or death from any cause, whichever comes first. If the subject has no disease progression during the trial period, PFS is defined as the last date until the subject's last confirmed progression-free survival.
Measured: 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)
Overall survival (OS) was defined from the date of enrollment to the date of death from any cause.
Measured: 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
Proportion of patients who meet the conditions for local treatment after treatment. mathematically, it can be expressed as: Proportion = (Number of patients eligible for local treatment / Total number of patients in the study) × 100%.
Measured: Up to 6 cycles of chemotherapy (each cycle is 21 days)
Safty
Number of subjects with each adverse event. Safety Evaluation Criteria: The National Cancer Institute Adverse Event Common Terminology Criteria (NCICTCAE V.5.0) were used to judge the adverse events and severity during the study.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start24 Jan 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SIDAN LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761417
- Sponsor's protocol ID
- NCC5006
- Status last verified
- Apr 2026
- First submitted
- 29 Dec 2024
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06761417
- Acronym / sponsor ID
- NCC5006
- Conditions
- Solid Tumors, Children, Adolescents
- Keywords
- Mitoxantrone liposomes, Solid tumor, Children and adolescents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-arm, multicenter clinical study named "A Prospective, Single-arm, Multicenter Clinical Study of Liposomal Mitoxantrone Combination Regimen in the Treatment of Relapsed and Refractory Solid Tumors in Children, Adolescents and Young Adults". The study aims to assess the safety and effectiveness of the liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors among children, adolescents, and young adults.
The research anticipates enrolling 49 patients meeting specific criteria. The inclusion criteria require patients to have a clear understanding of the study, sign the informed consent form voluntarily, fall within the age range of 6 - 24 years with an expected survival time exceeding 3 months, have histopathologically confirmed relapsed and refractory solid tumors of certain subtypes (such as bone and soft tissue tumors, neuroblastoma, etc.), possess measurable tumor lesions detectable by CT, enhanced CT, PET/CT or MRI, and meet specific Karnofsky and ECOG scores as well as requirements for bone marrow, liver, and kidney functions. Exclusion criteria cover those with hypersensitivity to study drugs, uncontrolled other malignancies, pregnant or lactating women, and those judged unsuitable by investigators.
The treatment regimen consists of capecitabine at a dose of 1000 mg/m² from day 1 to 14, twice daily, and anlotinib with the dose adjusted according to body weight for 14 days, with a 21-day cycle repeated 4 - 6 times. Patients achieving a partial response or better will undergo local treatment like surgery or radiotherapy.
The primary endpoint of the study is the objective response rate (ORR), while secondary endpoints include the proportion of patients eligible for local treatment after treatment, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse events evaluated by NCI CTCAE v5.0. This study holds great significance for exploring new treatment options for relapsed and refractory solid tumors in the target population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Liposomal Mitoxantrone Combination Regimen | Experimental | Drug: Mitoxantrone liposome, Drug: Capecitabine, Drug: AnlotinibMitoxantrone liposome+Capecitabine+Anlotinib |
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone liposomeMitoxantrone liposome: 16 mg/m^2, d1; Each 21-day cycle was used for a total of 4-6 cycles. | Drug | Liposomal Mitoxantrone Combination Regimen |
| CapecitabineCapecitabine 1000 mg/m^2, d1-14, bid; Each 21-day cycle was used for a total of 4-6 cycles. | Drug | Liposomal Mitoxantrone Combination Regimen |
| AnlotinibAnlotinib: 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. | Drug | Liposomal Mitoxantrone Combination Regimen |
Primary outcome
Rate of Objective response(ORR)
Time frame: Up to 6 cycles of chemotherapy (each cycle is 21 days)
Rate of Objective response (ORR) after 4 or 6 cycles of Liposomal Mitoxantrone Combination Regimen, including complete response (CR) and partial response (PR)
5 secondary outcomes
Rate of Disease control (DCR)
Time frame: Up to 6 cycles of Liposomal Mitoxantrone Combination Regimen (each cycle is 21 days)
Progression-free survival (PFS)
Time frame: 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)
Time frame: 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
Time frame: Up to 6 cycles of chemotherapy (each cycle is 21 days)
Safty
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoxantrone liposome, Capecitabine and Anlotinib in people with Solid Tumors and Children, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sidan Li (+86-0316-5917421, lisidan2006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Objective response(ORR) (time frame: Up to 6 cycles of chemotherapy (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2026.