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

NCT07137884 | Not Yet Recruiting Phase 2

• 1 other identifier: B2025-409-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhabdomyosarcoma Recurrent; Maintenance Treatment

Outcome Measures

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.

  2 year

Secondary Outcomes (3)

• 2-year DFS rate

  2 year after treatment

• 2-year OS rate

  2 year after treatment

• Adverse events (AE)

  2 year

Study Arms (2)

Combination medication group

EXPERIMENTAL

Drug: Anlotinib+Cyclophosphamide+Vinorelbine

Conventional maintenance treatment

ACTIVE COMPARATOR

Drug: Cyclophosphamide+Vinorelbine

Interventions

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.

Combination medication group

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.

Conventional maintenance treatment

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• 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;
• Daily hemoptysis of two teaspoons or more before enrollment;
• Patients with clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, bleeding hemorrhoids, bleeding gastric ulcers, baseline fecal occult blood ++ or above, or vasculitis;
• Arterial/venous thrombotic events occurring within 12 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
• Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.);
• Long-term unhealed wounds or fractures (pathological fractures caused by tumors are not included);
• Patients who have undergone major surgery or suffered severe traumatic injury, fracture or ulcer within 4 weeks of enrollment;
• Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;
• Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before enrollment ;
• Urinalysis indicates urine protein ≥++, and the 24-hour urine protein volume is confirmed to be ≥1.0 g;
• Serous cavity effusion (including pleural effusion, ascites, and pericardial effusion) with clinical symptoms requiring symptomatic treatment;
• Note: Asymptomatic patients with serous cavity effusion can be enrolled. Patients with symptomatic serous cavity effusion who have undergone active symptomatic treatment (anti-cancer drugs cannot be used to treat serous cavity effusion) and are judged by the researchers to be eligible for enrollment are allowed to be enrolled.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Gongdong, 510060, China

Location

Central Study Contacts

yizhuo zhang

CONTACT

0086-18819241079; zhangyzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-07

Locations

CN (1)