Clinical trial · Interventional
QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.
NCT06456528CI-TRIAL-00100647recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Treatment-Induced Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| QL0911 | Drug | — | UNRESOLVED |
| QL0911 plus Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- QL0911
- interventionNames
- Drug: QL0911
- type
- EXPERIMENTAL
- label
- QL0911 plus Placebo
- interventionNames
- Drug: QL0911 plus Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- The proportion of treatment responders.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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; * ECOG 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: * 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 hepatitis C antibody positive and detection of HCV-RNA exceeding the upper limit, patients with hepatitis B surface antigen positive and detection of HBV-DNA exceeding the upper limit, patients with severe cirrhosis, HIV 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
References
Publications (0)
Data not yet available
No reference posted for this study.