Actively Recruiting
Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors
Led by Changhai Hospital · Updated on 2026-03-25
40
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of gastrointestinal tumors including esophageal, gastric, or colorectal cancer
- Platelet count of at least 75 x 10⁹/L during the previous chemotherapy cycle and at least one high-risk bleeding factor such as history of bleeding, certain chemotherapy drugs, bone marrow infiltration, or radiotherapy
- Platelet count of at least 100 ± 25 x 10⁹/L at the current chemotherapy cycle
- Undergoing chemotherapy cycles of 14 or 21 days with requirement for at least one more treatment cycle
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Adequate blood counts, liver, and kidney function as defined by specific laboratory values
- Signed informed consent form
You will not qualify if you...
- Prior use of thrombopoietin receptor agonist (TPO-RA) drugs
- Conditions causing low platelets before treatment such as hypersplenism or immune thrombocytopenia
- History of blood clots (thrombosis)
- Blood diseases including anemia, leukemia, or autoimmune hemolytic diseases
- Major cardiovascular diseases such as recent heart attack, stroke, or brain bleeding
- Pregnant or breastfeeding women
- Participation in another drug clinical trial within the past 4 weeks
- Poor compliance or inability to cooperate or report treatment responses
- Need for other platelet-enhancing or antiplatelet drugs including herbal remedies
- Use of platelet-stimulating drugs within 5 half-lives before starting study drug
- Platelet transfusion within 3 days before starting study drug
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changhai Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xianbao Zhan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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