Clinical trial · Observational
TPO Combined With TPORA for Solid Tumors Effectiveness of cTit Above Degree II
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CTIT-Chemotherapy Induced Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypertrombopa | Drug | — | UNRESOLVED |
| rhTPO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group A
- description
- For ctit patients with platelet counts ≥50×109/L and \<75×109/L, they were randomized into groups A.
- interventionNames
- Drug: rhTPO
- Drug: hypertrombopa
- label
- Group B
- description
- For ctit patients with platelet counts \<50×109/L, they were randomized into groups B.
- interventionNames
- Drug: rhTPO
- Drug: hypertrombopa
Primary outcomes (1)
- measure
- Time for platelets to rise from nadir to 75 x 109/L
- timeFrame
- up to 4 weeks
- description
- Time for platelets to rise from nadir to 75 x 109/L
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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; * 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; * Other conditions that, in the judgment of the investigator, make inclusion in the study inappropriate.
References
Publications (0)
Data not yet available