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New drug aims to stop Chemo-Induced bleeding risk in stomach and colon cancers
NCT ID NCT07492693
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether the drug hetrombopag can prevent chemotherapy-induced thrombocytopenia (low platelet counts) in people with gastrointestinal tumors. The study will enroll 40 patients who had low platelets in a previous chemo cycle. Participants take hetrombopag daily for 14 days starting on the day of chemotherapy. The main goal is to see if platelet counts stay above a safe level.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hetrombopag
- What this could lead to
- If it works, this could offer a way to prevent dangerously low platelet counts during chemotherapy, reducing bleeding risks and treatment delays.
- What could go wrong
- This is a small, early-phase trial with only 40 participants and no comparison group. The results may not apply to all patients, and side effects are still being evaluated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Changhai Hospital
RECRUITINGShanghai, China
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