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

NCT06769685 | Enrolling By Invitation FDA Drug

• 1 other identifier: JinhuaCH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CTIT-Chemotherapy Induced Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Time for platelets to rise from nadir to 75 x 109/L

  Time for platelets to rise from nadir to 75 x 109/L

  up to 4 weeks

Secondary Outcomes (1)

• The time required for platelet count to rise to 100×10⁹/L, the proportion of patients with a delay of ≥7 days in the next cycle, bleeding, receiving platelet transfusion and treatment-related adverse reactions.

  up to 4 weeks

Study Arms (2)

Group A

For ctit patients with platelet counts ≥50×109/L and \<75×109/L, they were randomized into groups A.

Drug: rhTPO; Drug: hypertrombopa

Group B

For ctit patients with platelet counts \<50×109/L, they were randomized into groups B.

Drug: rhTPO; Drug: hypertrombopa

Interventions

rhTPO DRUG

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.

Group A; Group B

hypertrombopa DRUG

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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with tumor therapy-related thrombocytopenia treated with thrombopoietic agents

You may qualify if:

• Understand the study procedures and voluntarily sign the informed consent form to voluntarily enroll in this study;
• Age ≥ 18 years old;
• Receive anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) within 14 days prior to study entry;
• Anti-tumor therapy (see the subsequent 'Protocols for Reference' for details);
• Patients with two consecutive platelet counts \<75×109/L more than 24 hours apart, with a screening period of 3 days.

You may not qualify if:

• Previous use of rhTPO or TPORA analogs;
• Prior grade 2 or higher CTIT;
• Patients undergoing clinical interventional studies;
• Patients with a history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disorders, lymphoma, or myelodysplastic disorders;
• Patients with underlying liver disease (e.g., cirrhosis or chronic hepatitis) and no primary or metastatic cancer in the liver will be excluded if ALT/AST \>3X ULN or total bile \>3X ULN);
• Patients with the presence of primary or metastatic liver cancer will be excluded if ALT/AST \>5X ULN or total bile \>5X ULN;
• Patients with a history of symptomatic venous thrombotic events (e.g., DVT or pulmonary embolism) and symptomatic arterial thrombotic events (e.g., myocardial infarction, ischemic cerebral vascular accident, or transient ischemic attack) who are unable to tolerate anticoagulant therapy will be ineligible, and patients with D-dimer greater than 10,000 g/L will also be excluded;
• Serious concomitant medical conditions that may interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring intravenous antibiotics;
• Pregnant/nursing mothers and patients who do not wish to use contraception; Inability to understand the research nature of the study or failure to obtain informed consent;

Sponsors & Collaborators

• Jinhua Central Hospital: lead

Study Sites (1)

Jinhua Central Hospital

Jinhua, Zhejiang, 321000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Information about patients will be collected prospectively in this study, which will collect information about all enrolled patients' two tumor treatment cycles and prothrombogenic drug therapy during them. The data to be collected will include the patient's baseline characteristics, the dose, frequency, and duration of each study drug, the name, dose, frequency, and duration of any combinations of study drugs, laboratory tests (e.g., blood counts) before, during, and after treatment with each study drug, and records of adverse events, including those related to the patients' baseline characteristics. and other relevant content.

Study Officials

• Jianfei Fu, PhD

  Director of Medical Oncology Department of Jinhua Municipal Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 10, 2025
• Study Start: February 27, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

CN (1)