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Anlotinib Hydrochloride Capsules in Maintenance Treatment for Intermediate-High Risk Rhabdomyosarcoma in Children

ConditionsRhabdomyosarcoma RecurrentMaintenance Treatment
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-18
SponsorSun Yat-sen University

About this trial

This is a randomized controlled phase II clinical study aimed at evaluating the efficacy and safety of anlotinib hydrochloride in children with Intermediate-High -risk rhabdomyosarcoma. The study enrolled children with rhabdomyosarcoma confirmed by histopathology, with a clinical risk classification of high or Intermediate-risk accompanied by high-risk factors (high-risk factors are defined as age \> 10 years，Poor prognosis molecular characteristics or those who cannot undergo surgery/radiotherapy);One year of maintenance treatment with anlotinib can increase the duration of response and long-term survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Hypertensive patients who are currently receiving combined treatment with two or more antihypertensive drugs;

Patients with the following cardiovascular diseases: Myocardial ischemia or myocardial infarction of grade II or above, poorly controlled arrhythmia (including QTc interval ≥450 ms for men and ≥470 ms for women); Grade III to IV heart failure according to NYHA standards, or left ventricular ejection fraction (LVEF) <50% as indicated by cardiac ultrasound examination;

Patients with a history of or concurrent interstitial lung disease;

Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds or APTT>1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anlotinib+Cyclophosphamide+Vinorelbine

    Drug

    Anlotinib hydrochloride capsules combined with Cyclophosphamide+Vinorelbine), Anlotinib hydrochloride capsules 8mg (weight ≤35kg) or 12mg (weight \> 35kg), po, qd, D1-D14;on an empty stomach ,Two weeks off for one week，with a cycle of 3 weeks. Cyclophosphamide 25mg/m2, po, qd, D1-D28, with a cycle of 4 weeks. vinorelbine 60g/m2, po, qw, D1, 8,15, with a cycle of 4 weeks.

  • Cyclophosphamide+Vinorelbine

    Drug

    Cyclophosphamide 25mg/m2, po, qd, D1-D28, with a cycle of 4 weeks. vinorelbine 60mg/m2, po, qw, D1, 8,15, with a cycle of 4 weeks.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Combination medication groupExperimental treatment 1 intervention
Group B: Conventional maintenance treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

DOR (Duration of Response)

DOR (Duration of Response) refers to the period from the first assessment of complete response (CR) or partial response (PR) of the tumor to the first assessment of disease progression (PD) or death from any cause.

Time frame
2 year

Secondary outcomes

1

2-year DFS rate

The 2-year DFS rate refers to the probability that a patient does not experience disease recurrence or progression within 2 years after cancer treatment.

Time frame
2 year after treatment
2

2-year OS rate

2-year OS rate is defined as the percentage of patients who do not experience death from any cause after 2-year treatment.

Time frame
2 year after treatment
3

Adverse events (AE)

An AE refers to any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment. Number and classification of participants with treatment-related adverse events as assessed by CTCAE v5.0 were recorded.

Time frame
2 year

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Sun Yat-Sen University Cancer Center

Sponsor institution

Source ClinicalTrials.gov

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