Clinical trial NCT06769685: TPO Combined With TPORA for Solid Tumors Effectiveness of cTit Above Degree II
Official title: TPO Combined With TPORA for Solid Tumors Effectiveness of cTit Above Degree II
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CTIT-Chemotherapy Induced Thrombocytopenia
Lead sponsor: Jinhua Central Hospital
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with tumor therapy-related thrombocytopenia treated with thrombopoietic agents

Brief summary: In this study, real-world data related to the study drug will be prospectively collected, and 150 patients are proposed to be observed for disease characteristics and treatment patterns of oncology treatment-related thrombocytopenia. Patients were categorized into 2 groups based on their platelet ratio: platelet count ≥50×109/L, \<75×109/L and platelet count \<50×109/L. This study was divided into 3 treatment groups (1:1:1): group A (secondary control), group B (secondary dichotomy), and group C (tertiary dichotomy). For platelet counts ≥50×109/L and \<75×109/L, they were randomized into groups A and B. Group A was treated with basal therapy including drugs such as interleukin-11, Ricocin, and Epsilon, while group B was treated with rhTPO and Hetropoxa, and was medicated until the PLT was ≥75×109/L. Patients with platelet counts \<50×109/L were enrolled in group C. All of them were treated with rhTPO and hypertrombopa and were medicated to a PLT ≥75 × 109/L. Basal therapy respected the investigator's choice of administration. Information about patients will be collected prospectively in this study, which will collect information about two tumor treatment cycles and pro-plateletogenic drug therapy during them for all included patients. The data to be collected will include the patients' tumor treatment cycle N(each cycle is 14 days or 21 days) and N+1 during two consecutive cycles of chemotherapy: baseline characteristics of the patients, the dose, frequency and duration of administration of each study drug, the name, dose, frequency and duration of combinations of medications related to the study drugs, the relevant laboratory tests and imaging examinations, and the records of adverse events prior to, during, and after the treatment with each study drug. Relevant content.

Detailed description: This research will gather real-world data on an investigational drug in a prospective manner, aiming to monitor 150 patients to explore the characteristics and treatment approaches of thrombocytopenia associated with tumor therapy. Participants will be divided into two categories based on their platelet levels: those with platelet counts ≥ 50×10\^9/L and \< 75×10\^9/L, and those with platelet counts \< 50×10\^9/L. The study design includes three treatment arms (in a 1:1:1 ratio): Arm A (secondary control), Arm B (secondary combination), and Arm C (tertiary combination).

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, 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.

For patients in Arm C, who have platelet counts below 50×10\^9/L, all will receive treatment with rhTPO and eltrombopag until their platelet count reaches at least 75×10\^9/L. The choice of standard care medications will be made at the discretion of the investigators.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time for platelets to rise from nadir to 75 x 109/L
timeFrame: up to 4 weeks
Secondary outcomes:
measure: 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.
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Director of Medical Oncology Department of Jinhua Municipal Central Hospital
name: Jianfei Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References: