A Single-Center, Prospective, Real-World Study to Evaluate the Efficacy and Safety of Romiplostim N01 (Ruilisheng®) in Patients with Solid Tumors and Cancer Therapy–Induced Thrombocytopenia (CTIT)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600124107

Enrollment

Unknown

Registered

2026-05-07

Start date

2026-05-07

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Therapy–Induced Thrombocytopenia(CTIT)

Interventions

Observation group:None

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years, male or female; 2. Histologically or cytologically confirmed solid tumors; 3. Patients currently receiving anticancer therapy, including but not limited to chemotherapy, radiotherapy, immunotherapy, targeted therapy, or combination regimens; 4. Development of thrombocytopenia during anticancer treatment, with a platelet count =75 × 10^9/L within 3 days prior to enrollment; 5. Estimated life expectancy >=3 months at screening; 6. Ability to fully understand and comply with the study requirements, and voluntary provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity or intolerance to the active ingredient or excipients of injectable Romiplostim N01; 2. Planned pregnancy or breastfeeding; 3. Patients deemed unsuitable for participation in the study by the investigator.

Design outcomes

Primary

Measure	Time frame
Proportion of response cycles Defined as the proportion of treatment cycles achieving response among all cycles in which Romiplostim N01 was used. Response is defined as no platelet transfusion and one of the following criteria being met: an increase in platelet count =50 × 10^9/L from baseline, or an increase to =2 times the baseline platelet count, or a platelet count >=100 × 10^9/L;	—

Secondary

Measure	Time frame
Median time to platelet count recovery to >=100 × 10^9/L;Proportion of cycles/patients receiving platelet transfusion due to thrombocytopenia during the treatment period;Proportion of cycles/patients achieving response within 7 days and within 14 days of treatment. Response is defined as no platelet transfusion and one of the following criteria being met: an increase in platelet count =50 × 10^9/L from baseline, or an increase to =2 times the baseline platelet count, or a platelet count >=100 × 10^9/L;Incidence of dose modification, treatment delay, or discontinuation of anticancer therapy due to thrombocytopenia;Safety will be evaluated based on adverse events, vital signs, physical examinations, laboratory tests, electrocardiograms, and other relevant clinical assessments;	—

Measure

Time frame

Median time to platelet count recovery to >=100 × 10^9/L;Proportion of cycles/patients receiving platelet transfusion due to thrombocytopenia during the treatment period;Proportion of cycles/patients achieving response within 7 days and within 14 days of treatment. Response is defined as no platelet transfusion and one of the following criteria being met: an increase in platelet count =50 × 10^9/L from baseline, or an increase to =2 times the baseline platelet count, or a platelet count >=100 × 10^9/L;Incidence of dose modification, treatment delay, or discontinuation of anticancer therapy due to thrombocytopenia;Safety will be evaluated based on adverse events, vital signs, physical examinations, laboratory tests, electrocardiograms, and other relevant clinical assessments;

—

Countries

China

Contacts

Public ContactLiu Yibing

The Fourth Hospital of Hebei Medical University

lyb.he@163.com+86 138 3117 3220

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026