Chemotherapy-induced Thrombocytopenia (CIT) in Patients With Gastrointestinal TumorsPhase 2NCT07492693
Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors
A Phase 2 study testing Hetrombopag in people with Chemotherapy-induced Thrombocytopenia (CIT) in Patients With Gastrointestinal Tumors, run by Changhai Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Thrombocytopenia (CIT) in Patients With Gastrointestinal Tumors
- What is being tested?
- Hetrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 1 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- undergoing treatment cycles of 14 or 21 days and requiring at least one more cycle of therapy.
- ECOG score: 0-2 points;
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- 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
- Signed informed consent form.
Who cannot join
- 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.);
- Major cardiovascular diseases (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.);
- Pregnant or breastfeeding women;
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- Participation in other drug clinical trials within 4 weeks;
- Poor compliance, unable to cooperate or report treatment responses;
- Need for other antiplatelet or platelet-enhancing drugs, including traditional Chinese medicine and herbal preparations;
- Use of prior platelet-stimulating drugs within 5 half-lives before first dose;
- Platelet transfusion within 3 days before first dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital
Shanghai
Shanghai Changhai Hospital, 86-21-31162338, changhaiec@126.com
About this study
Official title: Exploring the Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors
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.
- Being tested
- Hetrombopag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HetrombopagDrug
Hetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Hetrombopag Group | Experimental | Hetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days. Receives: Drug: Hetrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a platelet count >75×10⁹/L on day 14 (D14)
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (5)
The proportion of patients whose next chemotherapy cycle is delayed (≥4 days)
Measured: From enrollment up to Day 25
The proportion of patients with platelet count >75×10⁹/L on day 21 (D21)
Measured: From enrollment up to Day 21
The proportion with platelet count >100×10⁹/L on day 21 (D21)
Measured: From enrollment up to Day 21
The proportion of patients with platelet count <50×10⁹/L
Measured: From enrollment up to Day 21
The proportion of patients requiring platelet rescue therapy
Measured: From enrollment up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Oct 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Thrombocytopenia (CIT) in Patients With Gastrointestinal TumorsStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492693
- Sponsor's protocol ID
- CHEC2025-483
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Efficacy and Safety of Hetrombopag in Preventing Chemotherapy-induced Thrombocytopenia in Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT07492693
- Acronym / sponsor ID
- CHEC2025-483
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hetrombopag Group | Experimental | Drug: HetrombopagHetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
- undergoing treatment cycles of 14 or 21 days and requiring at least one more cycle of therapy.
Key exclusion criteria (11 listed)
- 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.);
- Major cardiovascular diseases (acute myocardial infarction, cerebral thrombosis, cerebral hemorrhage, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HetrombopagHetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days. | Drug | Hetrombopag Group |
Primary outcome
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
5 secondary outcomes
The proportion of patients whose next chemotherapy cycle is delayed (≥4 days)
Time frame: From enrollment up to Day 25
The proportion of patients with platelet count >75×10⁹/L on day 21 (D21)
Time frame: From enrollment up to Day 21
The proportion with platelet count >100×10⁹/L on day 21 (D21)
Time frame: From enrollment up to Day 21
The proportion of patients with platelet count <50×10⁹/L
Time frame: From enrollment up to Day 21
The proportion of patients requiring platelet rescue therapy
Time frame: From enrollment up to Day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hetrombopag in people with Chemotherapy-induced Thrombocytopenia (CIT) in Patients With Gastrointestinal Tumors, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianbao Zhan (+86 18801765535, zhanxianbao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.