NCT05708391
Not Yet Recruiting
Phase 2
Efficacy and Safety of Concurrent Radiotherapy With Realgar-Indigo Naturalis Formula in the Treatment of Childhood Rhabdomyosarcoma
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine0 sites53 target enrollmentJanuary 31, 2023
ConditionsRhabdomyosarcoma, Child
Overview
- Phase
- Phase 2
- Intervention
- Realgar-Indigo Naturalis Formulation
- Conditions
- Rhabdomyosarcoma, Child
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 53
- Primary Endpoint
- Objective response rate
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eastern Cooperative Oncology Group performance status score（ECOG PS）: 0-2, and the expected survival time is ≥3 months;
- •At least one measurable lesion according to RECIST version 1.1;
- •Postoperative pathological diagnosis of rhabdomyosarcoma, pathological staging of Group II-III patients;
- •Patients who have not previously received radiotherapy, have received chemotherapy or whose legal guardian refuses to receive chemotherapy, and may have received surgical treatment for the initial diagnosis;
- •Normal major organ function, i.e., meeting the following criteria:
- •Blood routine examination standards shall meet:(No transfusion within 14 days)
- •Hemoglobin(HB)≥90g/L;
- •Absolute Neutrophil Count（ANC）≥1.5×109/L;
- •Platelet count(PLT)≥80×109/L
- •Biochemical examination shall meet the following standards:
Exclusion Criteria
- •Previous or concurrent with other malignancies;
- •Persons who have been proved to be allergic to Realgar-Indigo naturalis formula and/or its excipients;
- •Has a number of factors affecting oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.) ;
- •Abnormal coagulation function (international normalized ratio(INR) \> 1.5, Activated Partial Thromboplastin Time(APTT) \> 1.5 uln) , the patients with bleeding tendency (such as active ulcer lesion in stomach, occult blood in stool (+ +) , black stool and/or hematemesis within 3 months, hemoptysis) or the lesion located near the great vessels;
- •Tumors involving the skin and/or pharyngeal mucosa with ulceration;
- •Have a history of psychotropic substance abuse and can not quit or have mental disorders;
- •patients who had participated in clinical trials of other drugs within 4 weeks;
- •The patients whose organ function had not recovered more than 35 days after the previous chemotherapy and could not be treated with the next course of chemotherapy;
- •No other anti-cancer treatment may be used during radiotherapy except for the treatment prescribed in the protocol;
- •According to the researchers' judgment, there are other patients with concomitant diseases that seriously compromise patient safety or affect the patient's ability to complete the study.
Arms & Interventions
Experimental arm: Radiotherapy, Realgar-Indigo naturalis formula
Intervention: Realgar-Indigo Naturalis Formulation
Experimental arm: Radiotherapy, Realgar-Indigo naturalis formula
Intervention: Radiotherapy
Outcomes
Primary Outcomes
Objective response rate
Time Frame: 1-year
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.
Secondary Outcomes
- Disease Control Rate(1-year)
- Overall survival(2-year)
- Quality of life score(1-year)
- Adverse events(1-year)
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