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Efficacy and safety of avatrombopag in immune/targeted/antiangiogenic hepatocellular carcinoma patients with thrombocytopenia

Efficacy and safety of avatrombopag in immune/targeted/antiangiogenic hepatocellular carcinoma patients with thrombocytopenia: a prospective, single-arm, multicenter study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065912
Enrollment
Unknown
Registered
2022-11-18
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatoma

Interventions

The experimental group:Avatrombopag was administered orally

Sponsors

Fuyang Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, aged >= 18 years; 2. Clinical diagnosis of liver cancer; 3. Receiving immunotherapy combined with targeted therapy or antivascular therapy and using at least one or more of the following drugs or not limited to the following drugs: (1) Immunodrugs, such as PD-1 inhibitors, PD-L1 inhibitors and CTLA-4 inhibitors; (2) Targeted therapies, such as tyrosine kinase inhibitors, cyclin dependent kinase inhibitors, histone deacetylation enzyme inhibitors and polyadenosine diphosphate ribose polymerase inhibitors; (3) Anti-angiogenic drugs, such as macromolecular drugs against VEGF/VEGFR, fusion proteins, etc.; 4. PLT <= 75 x 10^9/L in two consecutive cycles of immunocombined targeting/antivascular therapy with an interval of more than 48 hours; 5. The patient received avatripopa for thrombocytopenia and was scheduled to receive the next cycle of immunological combined targeted/antivascular therapy; 6. Receive PLT count examination and record the following information: (1) PLT count at least once within 5 days before medication; (2) PLT count at least once 5 +/- 2 days after medication; (3) PLT count at least once 10 +/- 2 days after medication; (4) PLT count at least once 15 +/- 2 days after medication; (5) If the primary efficacy end point was not met, PLT counts should be recorded at least once at 20 ±5 days after treatment; And so on The day of one cycle of treatment; 7. Eastern Collaborative Oncology Group (ECOG) Performance status score <= 2; 8. Voluntarily and strictly abide by the requirements of the study protocol and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. In addition to malignant tumor (solid tumor), the patient was also complicated with other hematological diseases, including immune thrombocytopenia and regenerative dysfunction, Obstructive anemia, Myelodysplastic syndrome, Hematological malignancies, etc.; 2. Liver cancer with bone marrow invasion or bone marrow metastasis; 3. Severe infection requiring intravenous antibiotics; 4. The patient had a history of radiotherapy with medical records; 5. PLT <= 100 x 10^9/L before the first cycle of immunological combined targeting/antivascular therapy, with causes other than target therapy thrombocytopenia, including but not limited to chronic liver disease related thrombocytopenia, immune thrombocytopenia (ITP), etc.; 6. Has medically known hereditary prethrombotic syndrome (e.g., coagulation factor V Ldeiden mutation, prothrombin G20210A process) Variant or hereditary antithrombin ? (AT III) deficiency); 7. The subjects had a history of arterial or venous thrombosis within 3 months before screening; 8. Thrombocytopenia caused by non-chemotherapy drugs, such as antibiotics and heparin; 9. Received platelet growth factor (Rhil-11, rhTPO, eltrombopa, hetrombopa, or ropsitine) 2 weeks before treatment, For the treatment of thrombocytopenia caused by targeted combined immunotherapy; 10. Participated in a clinical study of any other investigational drug or device, other than an observational study, within 30 days prior to screening; 11. At screening (as evidenced by a positive test for serum beta-human chorionic gonadotropin [beta-hCG]) or at baseline visit (urine) Female subjects who are breast-feeding or pregnant; 12. The patient has explicitly refused to use his medical records and specimens for scientific research.

Design outcomes

Primary

MeasureTime frame
Platelet count;

Countries

China

Contacts

Public ContactDa-Yong Luo

The Second People's Hospital of Fuyang,

wangjoe@ustc.edu.cn+86 13836135864

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026