Hetrombopag for treating low platelet counts during cancer therapy

A Single-arm, Phase II Trial of Hetrombopag for the Treatment of Concurrent Chemoradiotherapy-induced Thrombocytopenia in Patients With Advanced Solid Tumors

This study is testing if hetrombopag can help people with low platelet counts during cancer treatment feel better and avoid delays in their therapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06433830 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of hetrombopag, a thrombopoietin receptor agonist, in patients experiencing thrombocytopenia due to concurrent chemoradiotherapy for various cancers. The study focuses on patients with malignant tumors who have a platelet count of 75 × 10^9/L or lower. By administering hetrombopag, the trial aims to determine if it can help maintain platelet levels, thereby reducing the need for chemotherapy dose adjustments or delays. The study is conducted at Sir Run Run Shaw Hospital and involves patients aged 18 and older with specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with malignant tumors who develop thrombocytopenia during concurrent chemoradiotherapy.

Not a fit: Patients who do not experience thrombocytopenia or have platelet counts above 75 × 10^9/L may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could help maintain platelet counts in cancer patients undergoing chemoradiotherapy, potentially improving their treatment outcomes.

How similar studies have performed: Previous studies have shown that thrombopoietin receptor agonists can be effective in managing chemotherapy-induced thrombocytopenia, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years old, regardless of gender;
* Malignant tumor patients diagnosed through pathological or cytological examination, regardless of cancer type, may experience thrombocytopenia during radical synchronous radiotherapy and chemotherapy treatment;
* Platelet count of patients ≤ 75 × 10\^9/L on the day or 3 days prior to enrollment;
* Expected survival time ≥ 12 weeks;
* ECOG PS score for physical condition: 0-2 points;
* The laboratory inspection indicators meet the following requirements:

  1. Renal function: Cr ≤ ULN (upper limit of normal value) x 1.5, endogenous creatinine clearance rate (Ccr) ≥ 55 ml/min;
  2. Liver function: Total bilirubin ≤ ULN × 1.5; ALT and AST ≤ ULN × 3; (If it is intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin should not exceed 3 times the normal upper limit, and transaminase should not exceed 5 times the normal upper limit);
* Women of childbearing age agree to use contraception during the study period and within 6 months after the end of the study; And not a lactating patient; Male patients who agree to contraception during the study period and within 6 months after the end of the study;
* Those who have not participated in clinical trials of other drugs within the 4 weeks prior to enrollment;
* It is expected that those with good compliance will be able to follow up on therapeutic effects and adverse reactions according to the protocol requirements;
* No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal disorders Obstruction, non cancerous fever\>38 °C;
* The subjects are able to understand the situation of this study and voluntarily sign an informed consent form.

Exclusion Criteria:

* Screening for thrombocytopenia caused by non tumor treatment within the first 6 months, including but not limited to liver cirrhosis, splenic hyper function, infection, and bleeding;
* Suffering from other hematopoietic system diseases besides thrombocytopenia caused by concurrent radiotherapy and chemotherapy for malignant tumors, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
* Combined bone marrow invasion or bone marrow metastasis;
* After treatment with infusion of red blood cells or erythropoietin (EPO), hemoglobin remains below 50g/L, or after treatment with granulocyte colony-stimulating factor (G-CSF), the absolute value of neutrophils remains below 1.0 × 10\^9/L;
* Have received pelvic and spinal radiation therapy, as well as bone field radiation, within the three months prior to screening;
* History of arterial or venous thrombosis within the first 6 months of screening;
* Clinical manifestations of severe bleeding (such as gastrointestinal bleeding) within the first two weeks of screening;
* Received platelet transfusion within 2 days prior to enrollment;
* Screening for patients with severe cardiovascular diseases (such as NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, coronary stent implantation, angioplasty, and coronary artery bypass grafting within the first 6 months;
* Received treatment with recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), or thrombopoietin receptor agonists (such as eltrombopag, avatrombopag) within 14 days prior to screening;
* Patients who are known or expected to be allergic or intolerant to the active ingredients or excipients of hetrombopag tablets (excipients include cellulose lactose, low substituted hydroxypropyl cellulose, magnesium stearate, and film coated premixes);
* Breastfeeding women;
* Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, etc;
* The researcher believes that the participants are not suitable for enrollment.

Where this trial is running

Hangzhou, Zhejiang

• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Xiaonan Sun — Sir Run Run Shaw Hospital
• Study coordinator: Xiaonan Sun

Conditions: Thrombocytopenia, Radiotherapy Side Effect, hetrombopag, thrombocytopenia