Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in 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
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
Treatments tested in this trial
- Hetrombopag
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov