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Rhabdomyosarcoma

Myosarcoma

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Morphine

Radiotherapy: after 4 courses of chemotherapy, radiotherapy was started 13 weeks later. The radiotherapy was performed by three-dimensional conformal intensity modulated radiation (IMRT) technique with a dose of 45-50.4 grey, and radiotherapy was performed 5 times per week for 5-6 weeks.

Oral administration of Realgar-Indigo naturalis formula from 1 week before radiotherapy to the whole radiotherapy period.

Dosage: oral, according to body weight, 3 times a day.Because the patient constitution is different, may first start from the half dose, within 3 days gradually increases the dose.In this study, the dosage of Realgar-Indigo naturalis formula (250mg per tablet) was determined according to the patient's weight stage.In each body weight segment, 60 mg/kg realgar-indigo naturalis formula were given according to the upper limit of body weight

Realgar-Indigo Naturalis Formulation

Radiotherapy

SiYu Chen, Dr

The goal of this clinical trial\]is to evaluate the efficacy, safety and feasibility of radiotherapy combined with Realgar-Indigo naturalis formula（An oral arsenic agent）in the treatment of rhabdomyosarcoma in children. Including the occurrence of adverse events and the improvement of quality of life.

Radiotherapy Combined With Realgar-Indigo Naturalis Formula (RIF) in the Treatment of Rhabdomyosarcoma(RMS) in Children

Efficacy and Safety of Concurrent Radiotherapy With Realgar-Indigo Naturalis Formula in the Treatment of Childhood Rhabdomyosarcoma

It refers to the proportion of patients with tumor shrinkage reaching a certain level and maintaining it for a certain period of time, including CR and PR cases.Objective tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation criteria are divided into complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) according to RECIST 1.1 criteria.

Refers to the percentage of CR, PR and SD (≥4 weeks) cases in evaluable patients.

Refers to the time from the date of patient enrollment to death due to any cause.

Observe the adverse events occurring in all subjects during the clinical study

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Antineoplastic Agents

Anti-Infective Agents

Irinotecan

Doxorubicin

Liposomal doxorubicin

Temozolomide

Vincristine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Topoisomerase I Inhibitors

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Doxorubicin hydrochloride liposome injection combined with Irinotecan

Temozolomide combined with Irinotecan and Vincristine

Doxorubicin Hydrochloride Liposome+Irinotecan

Temozolomide+Irinotecan+Vincristine

zhang Yizhuo, PhD

This multicenter, randomized, controlled, open-label, prospective clinical trial was designed to evaluate the efficacy and safety of doxorubicin hydrochloride liposome injection in combination with irinotican (AI regimen) versus VIT regimen in the treatment of first relapsed and refractory pediatric rhabdomyosarcoma.

The primary objective of this study was to evaluate the objective response rate (ORR) of first relapsed and refractory rhabdomyosarcoma in children after 2 cycles of chemotherapy with AI or VIT regimens. Secondary objectives were to evaluate the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety of AI and VIT regimen in the treatment of relapsed and refractory pediatric rhabdomyosarcoma.

Doxorubicin Hydrochloride Liposome Combined With Irinotecan Versus VIT Regimen in the Treatment of Pediatric Rhabdomyosarcoma

Doxorubicin Hydrochloride Liposome Combined With Irinotecan (AI Regimen) Versus VIT Regimen in the Treatment of First Relapsed and Refractory Pediatric Rhabdomyosarcoma: a Prospective, Open-label, Randomized Controlled, Phase II Clinical Study

Objective response rate (ORR) after 2 cycles of chemotherapy with AI or VIT regimen, including complete response (CR) and partial response (PR)

Refers to the percentage of patients with confirmed complete response, partial response, and disease stability in patients with evaluable efficacy.

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.

Overall survival (OS) was defined from the date of enrollment to the date of death from any cause.

The safety of the drug was evaluated by NCI-CTC AE 5.0 standard.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiotherapy Combined With Realgar-Indigo Naturalis Formula (RIF) in the Treatment of Rhabdomyosarcoma(RMS) in Children	NCT05708391	Rhabdomyosarcom...	Realgar-Indigo ... Radiotherapy	3 Years - 18 Years	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Doxorubicin Hydrochloride Liposome Combined With Irinotecan Versus VIT Regimen in the Treatment of Pediatric Rhabdomyosarcoma	NCT05457829	Rhabdomyosarcom...	Doxorubicin Hyd... Temozolomide+Ir...	6 Months - 18 Years	Sun Yat-sen University
Doxorubicin Hydrochloride Liposome Combined With Irinotecan Versus VIT Regimen in the Treatment of Pediatric Rhabdomyosarcoma	NCT05457829	Rhabdomyosarcom...	Doxorubicin Hyd... Temozolomide+Ir...	6 Months - 18 Years	Sun Yat-sen University

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