Evaluation of the Efficacy and Safety of Pazopanib in Combination with TGI/CIV for Recurrent or Refractory Rhabdomyosarcoma in Children or Adolescents

Phase 2

Recruiting

• Conditions: Rhabdomyosarcoma, Recurrent, Refractory
• Interventions: Drug: pazopanib; Drug: TGI chemotherapy; Drug: CIV chemotherapy

• Registration Number: NCT06816771
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

To evaluate the efficacy and safety of pazopanib combined with TGI/CIV chemotherapy in children and adolescents with recurrent or refractory rhabdomyosarcoma.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	TGI chemotherapy	The participant take pazopanib once daily orally in combination with a total of 2 cycles(6 weeks) of TGI chemotherapy(nab⁃Paclitaxel+ gemcitabine + ifosfamide)/CIV(cyclophosphamide +Irinotecan + vinorelbine).Each cycle of TGI/CIV chemotherapy will last for 3 weeks, TGI will be given in cycle 1 and CIV will be given cycle 2 . At week 6, the participant will have scans and tests to reevaluate the tumor's response to the treatment. The participant will receive an additional 6 weeks (2 cycles) of the same chemotherapy in the absence of disease progression or unacceptable toxicity. After 4 cycles of chemotherapy, The investigator will re-evaluate the tumor again at week 12 and the patient will undergo other treatments(chemotherapy, radiation, surgery, etc.), but will be closely watched for any signs of tumor recurrence or progression.
Experimental group	pazopanib	The participant take pazopanib once daily orally in combination with a total of 2 cycles(6 weeks) of TGI chemotherapy(nab⁃Paclitaxel+ gemcitabine + ifosfamide)/CIV(cyclophosphamide +Irinotecan + vinorelbine).Each cycle of TGI/CIV chemotherapy will last for 3 weeks, TGI will be given in cycle 1 and CIV will be given cycle 2 . At week 6, the participant will have scans and tests to reevaluate the tumor's response to the treatment. The participant will receive an additional 6 weeks (2 cycles) of the same chemotherapy in the absence of disease progression or unacceptable toxicity. After 4 cycles of chemotherapy, The investigator will re-evaluate the tumor again at week 12 and the patient will undergo other treatments(chemotherapy, radiation, surgery, etc.), but will be closely watched for any signs of tumor recurrence or progression.
Experimental group	CIV chemotherapy	The participant take pazopanib once daily orally in combination with a total of 2 cycles(6 weeks) of TGI chemotherapy(nab⁃Paclitaxel+ gemcitabine + ifosfamide)/CIV(cyclophosphamide +Irinotecan + vinorelbine).Each cycle of TGI/CIV chemotherapy will last for 3 weeks, TGI will be given in cycle 1 and CIV will be given cycle 2 . At week 6, the participant will have scans and tests to reevaluate the tumor's response to the treatment. The participant will receive an additional 6 weeks (2 cycles) of the same chemotherapy in the absence of disease progression or unacceptable toxicity. After 4 cycles of chemotherapy, The investigator will re-evaluate the tumor again at week 12 and the patient will undergo other treatments(chemotherapy, radiation, surgery, etc.), but will be closely watched for any signs of tumor recurrence or progression.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR)	Up to 4 cycles of chemotherapy (each cycle is 21 days)	Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 4 cycles of chemotherapy (each cycle is 21 days)	Use NCI-CTCAE version 5.0 for classification and grading
Disease control rate (DCR)	Up to 4 cycles of chemotherapy (each cycle is 21 days)	Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy

Trial Locations

Locations (1)

No. 440 Jiyan Road, Jinan City, Shandong Province; 🇨🇳 Jinan, Shandong, China