Hetrombopag to prevent chemotherapy-related low platelets in gastrointestinal tumors

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

This study will try hetrombopag to prevent low platelet counts in adults with gastrointestinal cancers who had platelet drops from prior chemotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT07492693 on ClinicalTrials.gov

What this trial studies

This is a single-arm, prospective phase 2 trial enrolling about 40 patients with gastrointestinal tumors who develop chemotherapy-induced thrombocytopenia. Participants will keep the same chemotherapy regimen and on the day of the next cycle begin oral hetrombopag 7.5 mg once daily on an empty stomach for 14 consecutive days. Key eligibility includes prior platelet trends (≥75×10⁹/L in the previous cycle and ≥100±25×10⁹/L in the current cycle), at least one high-risk bleeding factor, ECOG 0–2, and adequate organ function. The study will monitor platelet counts and adverse events to characterize the drug's safety and ability to reduce clinically significant thrombocytopenia while allowing continued chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults with pathologically confirmed gastrointestinal tumors on 14- or 21-day chemotherapy cycles who had prior chemotherapy-associated platelet drops, meet the specified platelet thresholds, have at least one high-risk bleeding factor, and have ECOG 0–2 with adequate organ function.

Not a fit: Patients with severe baseline thrombocytopenia outside the study thresholds, significant hepatic impairment, uncontrolled thrombosis risk, or those not able to attend the single-center visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, hetrombopag could reduce episodes of low platelets and help patients stay on their planned chemotherapy without delays or dose reductions.

How similar studies have performed: Other thrombopoietin receptor agonists have shown benefit for chemotherapy-related or treatment-related thrombocytopenia in some settings, but hetrombopag specifically has limited published data for this indication.

Eligibility criteria

Inclusion Criteria:

1. age ≥18 years;
2. pathologically confirmed gastrointestinal tumors (including esophageal cancer, gastric cancer, colorectal cancer, etc.);
3. 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);
4. during the current chemotherapy cycle (N cycle), patients have a platelet count of ≥100±25×10⁹/L;
5. undergoing treatment cycles of 14 or 21 days and requiring at least one more cycle of therapy.
6. ECOG score: 0-2 points;
7. Adequate hematopoietic, liver, and kidney function:

   * Neutrophil count ≥ 1.5 x 10⁹/L
   * Hemoglobin ≥ 9.0 g/dL
   * Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
   * For patients without liver metastasis, AST and ALT ≤ 2.5 times the upper limit of normal;
   * Bilirubin ≤ 2 times the upper limit of normal;
   * APTT and PT ≤ 1.5 times the upper limit of normal
8. Signed informed consent form.

Exclusion Criteria

1. Previous use of TPO-RA drugs;
2. Pre-treatment conditions that cause thrombocytopenia, such as hypersplenism or immune thrombocytopenia;
3. History of thrombosis;
4. Hematologic diseases (anemia, leukemia, autoimmune hemolytic diseases, etc.);
5. Major cardiovascular diseases (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.);
6. Pregnant or breastfeeding women;
7. Participation in other drug clinical trials within 4 weeks;
8. Poor compliance, unable to cooperate or report treatment responses;
9. Need for other antiplatelet or platelet-enhancing drugs, including traditional Chinese medicine and herbal preparations;
10. Use of prior platelet-stimulating drugs within 5 half-lives before first dose;
11. Platelet transfusion within 3 days before first dose.

Where this trial is running

Shanghai

• Shanghai Changhai Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xianbao Zhan

Conditions Chemotherapy-induced Thrombocytopenia in Patients With Gastrointestinal Tumors