A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 3

Conditions: Patients With Chemotherapy-Induced Thrombocytopenia

Treatments: Drug: Hetrombopag Olamine; Drug: Hetrombopag Olamine ；Hetrombopag Olamine Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07286032

SHR8735-303

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female gender, age ≥18 years at screening.
2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
3. Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
5. Life expectancy ≥6 months.
6. Signed ICF for voluntary participation in the study and good compliance.

Exclusion criteria

1. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
2. Hematologic malignancies.
3. Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
4. Untreated brain metastases; or with leptomeningeal metastasis.
5. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
6. Severe cardiovascular disorders or interventions within 6 months
7. Have arterial/venous thrombosis within 6 months
8. Known bleeding disorders, platelet dysfunction
9. Severe haemorrhage during screening
10. Acute or uncontrolled hepatitis B&C infection
11. Human immunodeficiency virus (HIV) infection.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Part A: Hetrombopag Olamine

Experimental group

Treatment:

Drug: Hetrombopag Olamine

Part B：Hetrombopag Olamine vs Hetrombopag Olamine Placebo

Experimental group

Treatment:

Drug: Hetrombopag Olamine ；Hetrombopag Olamine Placebo