Actively Recruiting
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors
Led by Peking University People's Hospital · Updated on 2026-05-14
220
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
P
Peking University People's Hospital
Lead Sponsor
P
Peking University Cancer Hospital and Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of gastrointestinal/digestive system solid tumors, including but not limited to gastrointestinal tract, pancreatic, and colorectal cancers. Eligible participants will be randomized in a 1:1 ratio to receive Romiplostim N01 plus oral ATRA or Romiplostim N01 alone for 12 weeks, with follow-up through Week 24. The primary outcome is the overall platelet response rate at Week 12, defined as platelet count \>50 x 10\^9/L in at least 2 of the last 3 scheduled platelet assessments up to Week 12. Secondary outcomes include sustained response during Weeks 13 to 24, complete and partial response rates, duration of response, time to response, platelet count changes, platelet transfusion requirements, bleeding events, and safety.
CONDITIONS
Official Title
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Prior diagnosis of gastrointestinal, pancreatic, colorectal, or other digestive system solid tumors
- Complete remission of tumor after chemotherapy with no evidence of recurrence or progression and treatment stopped at least 12 weeks before enrollment
- Persistent isolated chemotherapy-induced thrombocytopenia with platelet count <30 x 10^9/L on two tests at least 7 days apart or dependence on platelet transfusions to maintain safe levels
- Thrombocytopenia persists since last chemotherapy without signs of spontaneous recovery
- Red blood cell and neutrophil counts generally preserved without significant anemia or neutropenia
- Bone marrow assessment within 1 year after tumor diagnosis and chemotherapy showing no tumor infiltration; normal or increased megakaryocyte count
- No hepatosplenomegaly, portal hypertension, or other causes of abnormal platelet distribution
- Prior treatment with at least one thrombopoietin receptor agonist or recombinant thrombopoietin without sufficient platelet response
- No prior use of Romiplostim N01
- Other platelet-raising medications discontinued before enrollment; investigational or off-label treatments stopped at least 1 month before enrollment
- Ability to understand and sign informed consent and comply with study procedures
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception during treatment
You will not qualify if you...
- Other hematologic diseases affecting blood cell production or causing thrombocytopenia, such as aplastic anemia, myelodysplastic syndrome, leukemia, hematologic malignancies, or primary immune thrombocytopenia
- Active recurrence or progression of tumor, bone marrow metastasis, or tumor cell infiltration
- Uncontrolled chronic viral infections like hepatitis B, hepatitis C, or HIV, or active severe infection within 4 weeks before screening
- Severe heart, liver, kidney, or other organ dysfunction or serious diseases preventing study treatment
- Pregnancy or breastfeeding
- Known severe allergy to Romiplostim, Romiplostim N01, ATRA, or components of the study drugs
- Prior Romiplostim treatment with severe adverse reactions or lack of efficacy
- Poor compliance, inability to complete treatment or follow-up, psychiatric or psychological conditions limiting understanding or increasing study risks as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
Research Team
X
Xiaohui Zhang, MD
CONTACT
K
Kexin Shen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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