ClinicalTrials.gg
RecruitingNCT06456528Updated Sep 9, 2026

QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia

A Phase 2/3 interventional study of QL0911 and QL0911 plus Placebo in Cancer Treatment-Induced Thrombocytopenia, sponsored by Qilu Pharmaceutical Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
235
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 108 studies in Thrombocytopenia with a site in China — 42 open to participants now, 45 under way, 10 of them phase 3. Thrombocytopenia · China.

Planned enrollment
10th of 96
235 · median 82
Started
2024
with 8 others
Phase 2/3
12 of 108
4 open now
Primary completion
2027-04
later than 31 of 44 live
Registered
75th of 108
by date
Lead sponsor
3 of 108
Qilu Pharmaceutical Co., Ltd.

Among the 108 studies in Thrombocytopenia with a site in China, this one is the 10th largest by planned enrollment of the 96 interventional ones that give a count, is one of 9 that started in 2024, is one of 12 in phase 2/3, reaches primary completion later than 31 of the 44 other live ones, and was the 75th registered.

Thrombocytopenia

482 studies on the registry are indexed under Thrombocytopenia; 100 are open to participants now.

Browse Thrombocytopenia studies →

Open to participants now

42 of the 108 studies in Thrombocytopenia with a site in China are open now. Recruiting first, the newest first:

36 more — sign in →

All 42 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

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.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 108 studies in Thrombocytopenia with a site in China, or all of them as a file.
02

Study summary

To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.

03

Conditions studied

  • Cancer Treatment-Induced Thrombocytopenia

Browse trials for

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

  • Men and women, 18-75 years of age;
  • Histopathological or cytological examination confirmed cancer , chemotherapy cycle of 21 days;
  • Participant experienced thrombocytopenia and chemotherapy delay;
  • performance status 0-1;
  • The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles.

Exclusion criteria

Exclusion Criteria:

  • Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
  • Participant has serious bleeding symptoms;
  • History of allergy to the study drug;
  • Patients with antibody positive and detection of HCV-RNA exceeding the upper limit, patients with surface antigen positive and detection of HBV-DNA exceeding the upper limit, patients with severe cirrhosis, antibody positive and syphilis antibody positive;
  • Pregnant or lactating women;
  • Participant has received any experimental therapy within 28 days prior to screening
  • Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Terms in these criteria, in plain language(4)

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.

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.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

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 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
235 participants (estimated)

Study arms

  • Experimental
    QL0911

    Drug: QL0911

  • Experimental
    QL0911 plus Placebo

    Drug: QL0911 plus Placebo

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugQL0911

    QL0911

  • DrugQL0911 plus Placebo

    QL0911 plus Placebo

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. The proportion of treatment responders.

    Time frame: Randomization up to 80 days

Secondary outcomes

  1. Duration from the commencement of treatment to a platelet count ≥100×109/L

    Time frame: Randomization up to 30 days

  2. Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy

    Time frame: Randomization up to 150 days

  3. Number of adverse events (AEs)/serious adverse events (SAEs)

    Time frame: Randomization up to 150 days

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2024 (actual). Primary completion is estimated for Apr 2027, 30 months after the start.

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

Registered
Jun 7, 2024
First posted
Jun 13, 2024
StartActual
Oct 22, 2024
Primary completionEst.
Apr 30, 2027
CompletionEst.
Jul 30, 2027
Last update
Sep 9, 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.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06456528
Responsible party
Sponsor
First posted
Jun 13, 2024
Start date
Oct 22, 2024
Primary completion
Apr 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Jun Ma
Contact
majun0322@126.com
0451-84883471
Shukui Qin
Contact
qinsk81@163.com
025-84453932

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: QL0911

Start the discussion