NCT06769685

TPO Combined With TPORA for Solid Tumors Effectiveness of cTit Above Degree II

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Jinhua Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was an open-label, controlled, single-center, prospective phase II trial. In this prospective, real-world study, consecutive patients meeting eligibility criteria will be enrolled and allocated to: Group A (Grade Ⅱ CTIT, PLT:50-75\*10\^9/L) and Group B (Grade Ⅲ or higher CTIT，PLT:\<50\*10\^9/L). Both groups received rhTPO and Hetrombopag treatment. A target sample size of 100 participants will be observed to characterize the clinical features and treatment patterns of cancer therapy-induced thrombocytopenia. Recombinant human thrombopoietin (rhTPO) and hetrombopag will be administered until a platelet count ≥ 75 × 10⁹/L is achieved. Beyond the protocol-specified dual therapy, basic management, including supportive care or concomitant medications-will remain at the investigator's discretion.

Detailed description

This research will gather real-world data on an investigational drug in a prospective manner, aiming to monitor 100 patients to explore the characteristics and treatment approaches of thrombocytopenia associated with tumor therapy. In this prospective, real-world study, consecutive patients meeting eligibility criteria will be enrolled and allocated to: Group A (Grade Ⅱ CTIT, PLT:50-75\*10\^9/L) and Group B (Grade Ⅲ or higher CTIT，PLT:\<50\*10\^9/L). Patients with platelet counts between 50×10\^9/L and 75×10\^9/L will be randomly allocated to either Arm A or Arm B. In Arm A and Arm B, participants will receive standard care, which may include medications such as interleukin-11, leucogen, and yixuesheng. Meanwhile, individuals in Arm B will be administered recombinant human thrombopoietin (rhTPO) and eltrombopag until their platelet count reaches or exceeds 75×10\^9/L. This study will prospectively gather relevant patient information. Data collection will occur over two tumor treatment cycles and during the administration of thrombopoietin-promoting drugs for all participants. Specifically, the following data will be collected for each patient across two consecutive chemotherapy cycles (Cycle N and Cycle N+1): * Patient baseline characteristics * Dosage, frequency, and duration of administration for each study drug * Details of concomitant medications related to the study drugs, including names, dosages, frequencies, and durations of administration * Laboratory test results and imaging examination findings before, during, and after treatment with each study drug * Records of any adverse events The aim is to comprehensively document these aspects to ensure thorough analysis and evaluation.

Conditions

• CTIT-Chemotherapy Induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	rhTPO	In group A, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. In group B, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L.
DRUG	hypertrombopa	In group A, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. In group B, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L.

Timeline

• Start date: 2025-02-27
• Primary completion: 2026-01-31
• Completion: 2026-06-30
• First posted: 2025-01-10
• Last updated: 2025-12-19

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study