Clinical trial · Interventional
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.
Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.
NCT05864014CI-TRIAL-00088592active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.
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 |
|---|---|---|---|
| Chemotherapy-Induced Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hetrombopag | Drug | — | UNRESOLVED |
| Hetrombopag plus Placebo | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Hetrombopag
- interventionNames
- Drug: Hetrombopag
- type
- EXPERIMENTAL
- label
- Hetrombopag plus Placebo
- interventionNames
- Drug: Hetrombopag 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: 1. Men and women, 18-75 years of age; 2. Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents; 3. Participant experienced thrombocytopenia and chemotherapy delay; 4. ECOG performance status 0-1; 5. Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x ULN for participants without liver metastases or 5.0 x ULN for participant with liver metastases); 6. Adequate renal function; serum creatinine \< 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault） Exclusion Criteria: 1. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; 2. Participant has serious bleeding symptoms; 3. History of allergy to the study drug; 4. Participant with HIV; 5. Pregnant or lactating women; 6. Participant has received any experimental therapy within 4 weeks prior to screening 7. 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.