ClinicalTrials.gg
Not yet recruitingNCT07933146Updated Nov 12, 2026

Sequential Hetrombopag and Recombinant Human Thrombopoietin for Cancer Therapy-Induced Thrombocytopenia

A Phase 2 interventional study of Hetrombopag and recombinant human thrombopoietin and Recombinant Human Thrombopoietin in Thrombocytopenia, sponsored by The First Affiliated Hospital of Zhengzhou University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 18 studies testing recombinant human thrombopoietin in Thrombocytopenia — 6 open to participants now, 6 under way, 2 of them phase 3. recombinant human thrombopoietin · Thrombocytopenia.

Planned enrollment
8th of 18
96 · median 70
Started
2026
with 2 others
Phase 2
6 of 18
3 open now
Registered
18th of 18
by date
Lead sponsor
2 of 18
The First Affiliated Hospital of Zhengzhou University

Among the 18 studies testing recombinant human thrombopoietin in Thrombocytopenia, this one is the 8th largest by planned enrollment, is one of 3 that started in 2026, is one of 6 in phase 2, and was the 18th registered.

Thrombocytopenia

483 studies on the registry are indexed under Thrombocytopenia; 101 are open to participants now.

Browse Thrombocytopenia studies →

Open to participants now

6 of the 18 studies testing recombinant human thrombopoietin in Thrombocytopenia are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

About recombinant human thrombopoietin

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 66 Thrombocytopenia studies recruiting now, 44 (67%) set no upper age limit and 18 (27%) stop at 75 or younger; 10 take children under 18; 3 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 18 studies testing recombinant human thrombopoietin in Thrombocytopenia, or all of them as a file.
02

Study summary

This is a multicenter, randomized, exploratory clinical study. The study plans to enroll 96 participants with cancer therapy-induced thrombocytopenia. participants will be stratified by baseline platelet countand randomized 1:1 to the hetrombopag sequential group (Experimental Group A) or the recombinant human thrombopoietin (rhTPO) group (Experimental Group B).

03

Conditions studied

  • Thrombocytopenia

Browse trials for

Keywords

  • Hetrombopag
  • Cancer Therapy-induced Thrombocytopenia (CTIT)
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-75 years (inclusive), male or female;
  • Patients with or cytologically confirmed malignant tumors, including but not limited to lung cancer, breast cancer, colorectal cancer, gastric cancer, etc.;
  • Currently receiving anticancer therapy in 21-day cycles, with grade 3 or higher thrombocytopenia during treatment, and expected to be able to receive the current anticancer regimen for ≥ 1 more cycle;
  • PS score 0-2;
  • With permitted use of red blood cells, erythropoietin, and recombinant human granulocyte colony-stimulating factor consistent with routine clinical practice: (ANC) ≥ 1.0×10\^9/L and (Hb) ≥ 80 g/L;
  • No significant hepatic impairment;
  • No significant renal impairment;
  • Expected survival ≥ 12 weeks;
  • Female participants of must have a negative serum pregnancy test within 7 days before the first dose, must not be lactating, and must agree to use effective during the study and for 7 days after the last dose of study drug; male participants whose partners are women of childbearing potential must be surgically sterilized or must agree to use reliable contraception from the signing of the form until 7 days after the last dose of study drug;
  • Voluntary participation in this study with signed informed consent and good compliance.

Exclusion criteria

Exclusion Criteria:

  • Concomitant hematopoietic system diseases, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative neoplasms, multiple myeloma, and myelodysplastic syndromes;
  • Other diseases causing thrombocytopenia other than cancer therapy-induced thrombocytopenia (CTIT) within 6 months before randomization, including but not limited to chronic liver disease and hypersplenism;
  • Uncontrolled active infection;
  • Tumor bone marrow invasion or bone marrow ;
  • Severe cardiac clinical symptoms or diseases within 6 months before randomization;
  • Arterial or venous thrombotic events (stroke, , myocardial infarction, deep vein thrombosis, or pulmonary embolism) within 3 months before randomization, or clinical symptoms and history suggestive of thrombophilia;
  • Concomitant severe bleeding symptoms or clear clinical manifestations of bleeding tendency, such as gastrointestinal or cerebral hemorrhage;
  • Conditions affecting drug absorption (e.g., dysphagia, history of total gastrectomy);
  • Receipt of whole-pelvis, whole-spine, or extensive sternal radiotherapy in the previous cycle or expected during the current cycle;
  • Treatment with rhIL-11, rhTPO and/or TPO-RA drugs within 7 days before randomization;
  • Treatment with romiplostim or romiplostim N01 within 1 month before randomization;
  • transfusion within 3 days before randomization;
  • Known or expected allergy or intolerance to the active ingredients or of the study drug;
  • Known history of positive (HIV) test or acquired immunodeficiency syndrome (AIDS);
  • Known active viral hepatitis;
  • Any other condition that, in the investigator's opinion, poses a significant risk to the subject's health or safety or may affect the efficacy evaluation.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Hetrombopag sequential group

    Drug: Hetrombopag and recombinant human thrombopoietin

  • Experimental
    Recombinant human thrombopoietin group

    Drug: Recombinant Human Thrombopoietin

Interventions

  • DrugHetrombopag and recombinant human thrombopoietin

    hetrombopag (orally) + rhTPO (subcutaneous injection)

  • rhTPO (subcutaneous injection)

06

What researchers measure

Primary outcomes

  1. Response rate

    Proportion of participants achieving treatment response

    Time frame: Up to 6 weeks

Secondary outcomes

  1. the proportion of participants whose platelet count recovers to ≥ 80×10^9/L

    Time frame: Up to 14 days

  2. the proportion of participants whose platelet count recovers to ≥ 100×10^9/L

    Time frame: Up to 14 days

  3. Time to first platelet count ≥ 80×10^9/L

    Time frame: Up to 3 weeks

  4. Platelet counts at each visit

    Time frame: From randomization up to the end of Cycle 1 of on-study anti-tumor therapy (each cycle is 21 days)

  5. Proportion of participants receiving at least one platelet-raising rescue therapy

    Time frame: From randomization up to the end of Cycle 1 of on-study anti-tumor therapy (each cycle is 21 days)

  6. Bleeding events

    Time frame: From randomization up to the end of Cycle 1 of on-study anti-tumor therapy (each cycle is 21 days)

  7. Adverse events

    Time frame: Up to 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

Of 44 non-industry phase 2 interventional studies under Thrombocytopenia, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 83. This study's planned 12 months is below that.

Counting every sponsor, half of 54 studies reached it within 36 months; a quarter within 28 and three quarters within 81.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 12, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 30, 2027
CompletionEst.
Oct 31, 2028
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933146
Responsible party
Feng Wang (Chief Physician, Professor, Director of Oncology Ward, Doctoral Supervisor, The First Affiliated Hospital of Zhengzhou University) — Principal investigator
First posted
Nov 12, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Zhengzheng Shan
Contact
sally900603@126.com
+86-15639934037

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Recombinant human thrombopoietin

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