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Clinical trial of combining realgar-Indigo naturalis formula and Cisplatin to treat osteosarcoma patients after standard treatment failure

Clinical trial of combining realgar-Indigo naturalis formula and Cisplatin to treat osteosarcoma patients after standard treatment failure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079268
Enrollment
Unknown
Registered
2023-12-28
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteosarcoma

Interventions

Intervention group:combining realgar-Indigo naturalis formula and Cisplatin

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age 6-70 years old 2) Osteosarcoma patients who have failed standard treatments. Standard treatment failure is defined as tumor progression, recurrence or metastasis during or after the end of chemotherapy using first-line chemotherapy drugs (including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, etc.). 3) Imaging shows recurrence, enlargement of metastases or new metastases with a maximum diameter of =5 mm, and two consecutive CT scans (one month apart) confirm the presence of nodules, or puncture confirms metastases. 4) Understand the entire process of this study, voluntarily participate and sign the informed consent form. For subjects who cannot understand the informed consent form or cannot accurately express their wishes, their legal representative can sign the informed consent form and have the subject's fingerprint.

Exclusion criteria

Exclusion criteria: 1) Patients with incomplete data on previous diagnosis and treatment, or pathological white films of the primary tumor focus are unavailable 2) Patients with ECOG=3 points and cardiopulmonary function assessment results who cannot tolerate the expected treatment 3) Patients with serious heart, liver, kidney diseases, pregnant or lactating patients 4) Uncorrectable bleeding tendency or coagulation disorder 5) There is systemic infection or puncture site infection 6) The subject refused to join this study and had poor compliance. 7) According to the researcher's judgment, the patient may have other factors that may cause the study to be terminated midway, such as other serious diseases or serious laboratory abnormalities or other conditions that may affect the safety of the subjects or the trial data and factors such as family or society where samples were collected.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective response rate, ORR;Overall survival, OS;AER;

Countries

China

Contacts

Public ContactJunqiang Yin

The First Affiliated Hospital of Sun Yat-sen University

fungaiwai@163.com+86 20 8775 5766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026