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Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors

ConditionChemotherapy-induced Thrombocytopenia (CIT) in Patients With Gastrointestinal Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChanghai Hospital

About this trial

This trial is a single-arm, prospective clinical study aimed at evaluating the efficacy and safety of hetrombopag in preventing chemotherapy-induced thrombocytopenia (CIT) in patients with gastrointestinal tumors. The study plans to enroll 40 patients with gastrointestinal tumors who develop thrombocytopenia due to chemotherapy. Patients who meet the inclusion and exclusion criteria will maintain the same treatment regimen and dosage as the previous cycle (N-1 cycle). On the day of chemotherapy in the current cycle (N cycle), they will take hetrombopag (D1) at 7.5 mg/day orally for 14 consecutive days on an empty stomach, and may eat two hours after administration, avoiding taking it with meals.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥18 years;

pathologically confirmed gastrointestinal tumors (including esophageal cancer, gastric cancer, colorectal cancer, etc.);

during the previous chemotherapy cycle (N-1 cycle), patients had a minimum platelet count of ≥75×10⁹/L and at least one high-risk bleeding factor (① history of bleeding; ② previous treatment with platinum agents, gemcitabine, cytarabine, anthracyclines, etc.; ③ tumor cell bone marrow infiltration; ④ previous or ongoing radiotherapy, especially to long bones or flat bones such as the pelvis or sternum);

during the current chemotherapy cycle (N cycle), patients have a platelet count of ≥100±25×10⁹/L;

Disqualifiers

Previous use of TPO-RA drugs;

Pre-treatment conditions that cause thrombocytopenia, such as hypersplenism or immune thrombocytopenia;

History of thrombosis;

Hematologic diseases (anemia, leukemia, autoimmune hemolytic diseases, etc.);

Trial design

Design model

Single group

Treatments tested in this trial

  • Hetrombopag

    Drug

    Hetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Hetrombopag GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of patients with a platelet count >75×10⁹/L on day 14 (D14)

Time frame
From enrollment to the end of treatment at 2 weeks

Secondary outcomes

1

The proportion of patients whose next chemotherapy cycle is delayed (≥4 days)

Time frame
From enrollment up to Day 25
2

The proportion of patients with platelet count >75×10⁹/L on day 21 (D21)

Time frame
From enrollment up to Day 21
3

The proportion with platelet count >100×10⁹/L on day 21 (D21)

Time frame
From enrollment up to Day 21
4

The proportion of patients with platelet count <50×10⁹/L

Time frame
From enrollment up to Day 21

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

Source ClinicalTrials.gov
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