NCT06217003

Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma

A Phase II Clinical Study of Trilaciclib Combined With Chemotherapy for Perioperative Treatment of Osteosarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Xinxiang Medical College · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single arm phase II study aimed at evaluating the efficacy and safety of trilaciclib before perioperative chemotherapy in patients with osteosarcoma.

Detailed description

This study is a prospective, single arm phase II study aimed at evaluating the efficacy and safety of Trilaciclib before perioperative chemotherapy in patients with osteosarcoma.Patients diagnosed by pathology and evaluated by surgeons as having non metastatic resectable osteosarcoma, after signing informed consent, will be screened for eligible subjects to receive a treatment regimen of tralazilide before perioperative chemotherapy; The study will include 20 participants who will receive the following design scheme: During the preoperative neoadjuvant therapy period, the subjects will receive two cycles of preoperative neoadjuvant therapy:Trilaciclib is administered daily within 4 hours before chemotherapy, 240mg/m2, intravenously; The chemotherapy regimen is MAP regimen (doxorubicin 75mg/m2, cisplatin 120mg/m2, methotrexate 8-12g/m2); Recombinant human endostatin: 210 mg, CIV 72 hours, administration method: continuous intravenous infusion, starting from the first day of each cycle; The subject underwent preoperative imaging evaluation and surgical indication evaluation one week after the end of the last medication before surgery. Subjects who still have indications for surgery after completing the two cycles before neoadjuvant therapy will receive surgical treatment within one week. One week after surgery, the subjects began to receive a combination of trilaciclib chemotherapy (MAP regimen) and recombinant human endostatin adjuvant therapy for four cycles; Monitor adverse events (AE) throughout the entire study process and assess their severity level according to the guidelines listed in the National Cancer Institute (NCI) Common Terminology Standards for Adverse Events (CTCAE) version 5.0 or higher. Safety follow-up will be conducted on subjects receiving study treatment and early discontinuation of medication. The total survival of all subjects will be followed up until death, withdrawal of informed consent, or end of the study.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Trilaciclib	Preoperative application of trilaciclib during perioperative chemotherapy

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-02-01
• Completion: 2025-08-01
• First posted: 2024-01-22
• Last updated: 2024-01-22

Locations

1 site across 1 country: China