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

NCT ID: NCT07137884

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2028-12-30

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.

Detailed Description

Anlotinib Hydrochloride is a novel multi-target tyrosine kinase inhibitor.It can effectively inhibit kinases such as VEGFR, PDGFR, FGFR, c-Kit and Met, and has the functions of anti-tumor angiogenesis and inhibiting tumor growth.Especially for vascular endothelial growth factor receptor 2 (VEGFR2/KDR) and VEGFR3 shows a highly selective inhibitory effect, with a half-maximal inhibitory concentration (IC50) of less than 1.0 nM, which is significant, and has a significant anti-angiogenic effect.

Conditions

Rhabdomyosarcoma Recurrent; Maintenance Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination medication group

Group Type: EXPERIMENTAL

Anlotinib+Cyclophosphamide+Vinorelbine

Intervention Type: 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.

Conventional maintenance treatment

Group Type: ACTIVE_COMPARATOR

Cyclophosphamide+Vinorelbine

Intervention Type: 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.

Interventions

Anlotinib+Cyclophosphamide+Vinorelbine

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.

Intervention Type: DRUG

Cyclophosphamide+Vinorelbine

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.

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

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

2. 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;

3. Patients with a history of or concurrent interstitial lung disease;

4. 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;

5. Daily hemoptysis of two teaspoons or more before enrollment;

6. 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;

7. 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;

8. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.);

9. Long-term unhealed wounds or fractures (pathological fractures caused by tumors are not included);

10. Patients who have undergone major surgery or suffered severe traumatic injury, fracture or ulcer within 4 weeks of enrollment;

11. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;

12. Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before enrollment ;

13. Urinalysis indicates urine protein ≥++, and the 24-hour urine protein volume is confirmed to be ≥1.0 g;

14. Serous cavity effusion (including pleural effusion, ascites, and pericardial effusion) with clinical symptoms requiring symptomatic treatment;

15. 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.

16. Active infection requiring antimicrobial treatment (e.g., antibacterial drugs, antiviral drugs, excluding anti-hepatitis B treatment for chronic hepatitis B and antifungal drugs);

17. Those with a history of psychotropic drug abuse and unable to quit, or those with mental disorders;

18. Participated in other anti-tumor drug clinical trials within 4 weeks before enrollment;

19. Patients who have previously or concurrently suffered from other uncured malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer;

20. Use of drugs or foods that are known strong CYP3A4 inhibitors within 7 days before the first dose, including but not limited to: atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinafil, ritonavir, saquinavir, telithromycin, troleandomycin, and voriconazole;

21. Use of drugs known to be strong inducers of CYP3A4 within 12 days prior to the first dose, including but not limited to: carbamazepine, phenobarbital, phenytoin, rifabutin , and rifampicin;

22. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to take effective contraceptive measures;

23. The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.

24. When virological testing during the screening period shows any of the following:

HBsAg positive and HBV DNA above the upper limit of normal Anti-HCV positive and HCV RNA positive HIV positive

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yizhuo Zhang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Gongdong, China

Countries

China

Central Contacts

yizhuo zhang

Role: CONTACT

zhangyzh@sysucc.org.cn

0086-18819241079

Facility Contacts

zhang

Role: primary

zhangyzh@sysucc.org.cn

0086-18819241079

Other Identifiers

B2025-409-01

Identifier Type: -

Identifier Source: org_study_id