By InvitationNot Applicable

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

China100 participantsStarted 2025-02-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: up to 4 weeks

Trial details

NCT IDNCT06769685

SponsorJinhua Central Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More CTIT-Chemotherapy Induced Thrombocytopenia trials