Romiplostim N01 plus ATRA for persistent low platelets after cancer remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, randomized, open-label trial compares Romiplostim N01 with and without all-trans retinoic acid (ATRA) in adults who have persistent chemotherapy-induced thrombocytopenia after complete remission of gastrointestinal or digestive system cancers. Participants receive weekly Romiplostim N01 for 12 weeks and, in the experimental arm, daily oral ATRA in addition to the Romiplostim, with follow-up through week 24. The primary outcome is achieving a platelet count above 50 x 10^9/L on at least 2 of the last 3 assessments by week 12; secondary outcomes include duration of response, time to response, changes in platelet counts, and need for platelet transfusions. Safety and tolerability of the combination are also evaluated. Dose adjustments follow a predefined protocol based on platelet counts, and supportive care is provided as needed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older.
2. Prior diagnosis of a gastrointestinal/digestive system solid tumor, including but not limited to gastrointestinal tract, pancreatic, or colorectal cancer.
3. Complete remission of the underlying tumor after chemotherapy or antitumor treatment, with tumor-related treatment discontinued for at least 12 weeks before enrollment, no evidence of recurrence or progression by specialist assessment, and no current need for additional tumor-directed therapy.
4. Persistent isolated chemotherapy-induced thrombocytopenia, defined as platelet count \<30 x 10\^9/L on two peripheral blood tests at least 7 days apart; or platelet count slightly higher than 30 x 10\^9/L with dependence on platelet transfusion to maintain a safe platelet level.
5. Thrombocytopenia has persisted since the last chemotherapy treatment without a clear trend of spontaneous recovery.
6. Red blood cell count and neutrophil count are generally preserved, without clinically significant anemia or neutropenia.
7. Bone marrow assessment performed within 1 year after tumor diagnosis and chemotherapy shows no tumor cell infiltration; megakaryocyte count is normal or increased, with or without maturation impairment.
8. No hepatosplenomegaly, portal hypertension, or other evidence suggesting abnormal platelet redistribution as the main cause of thrombocytopenia.
9. Prior treatment with at least one thrombopoietin receptor agonist or recombinant human thrombopoietin for PICIT without response, defined as failure of platelet count to rise to a safe level or to at least 2 times baseline after at least 2 weeks of standard-dose treatment.
10. No prior use of Romiplostim N01.
11. Other platelet-raising medications have been discontinued before enrollment. No washout period is required for prior thrombopoietin receptor agonists; other investigational drugs or off-label treatments must be discontinued for at least 1 month before enrollment.
12. Ability to understand and sign the informed consent form and willingness to comply with study visits and procedures.
13. Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during study treatment.

Exclusion Criteria:

1. Other hematologic diseases that may affect hematopoiesis or cause thrombocytopenia, including but not limited to aplastic anemia, myelodysplastic syndrome, leukemia or other hematologic malignancies, or a clear history of primary immune thrombocytopenia.
2. Active recurrence or progression of the underlying tumor, or evidence of bone marrow metastasis or tumor cell infiltration on bone marrow examination.
3. Uncontrolled chronic viral infection, including hepatitis B, hepatitis C, or HIV infection, or active severe infection at screening or within 4 weeks before screening.
4. Severe cardiac, hepatic, renal, or other organ dysfunction, or any serious organic disease that would make the participant unable to tolerate study treatment.
5. Pregnancy or breastfeeding.
6. Known severe hypersensitivity to Romiplostim, Romiplostim N01, ATRA, or any component of the study drugs.
7. Prior Romiplostim treatment associated with severe adverse reactions or lack of efficacy.
8. Poor compliance, inability to complete treatment or follow-up, psychiatric or psychological condition that prevents understanding of the study procedures, or any other condition that, in the investigator's judgment, may increase study risk or interfere with interpretation of study results.

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Xiaohui Zhang, MD — Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology
• Study coordinator: Xiaohui Zhang, MD
• Email: zhangxh@bjmu.edu.cn
• Phone: +8610-8832-4672

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• MGC030 in adults with advanced solid tumors

  This trial tests MGC030 in adults with advanced urothelial, gastric/GEJ, esophageal, colorectal, gastric, pancreatic, or GEJ cancers to see if it is safe and whether it can shrink tumors or stop growth.

  Recruiting Phase 1 MacroGenics · Lake Success, New York · NCT07822399

• GLP-1 RA plus standard treatment in first-line metastatic GI cancers

  This early-phase trial tests whether adding a GLP-1 receptor agonist to standard first-line chemotherapy is safe and feasible for people with metastatic pancreatic, colorectal, or liver cancer.

  Recruiting Early Phase 1 University of Arizona · Tucson, Arizona · NCT07627191

• Romiplostim N01 plus ATRA for persistent chemotherapy-induced low platelets after remission from gynecologic, breast, or lung cancer

  This trial tests whether adding ATRA to Romiplostim N01 helps people keep a safe platelet count after finishing chemotherapy for certain cancers.

  Recruiting Phase 2 Peking University People's Hospital · Beijing · NCT07586826

• CAIX-targeted 18F-T2 PET/CT imaging in solid tumors

  This study tests a CAIX-specific radioactive tracer to see if PET/CT can help visualize solid tumors and checks safety and radiation exposure in adults with certain cancers.

  Recruiting Peking University First Hospital · Beijing, Beijing Municipality · NCT07557225

• LRRC15-targeted PET imaging for more precise diagnosis and staging of pancreatic, breast, lung, sarcoma and head-and-neck cancers

  This project tests whether an LRRC15-targeted PET scan can better detect and stage LRRC15-expressing cancers and measures how the tracer behaves in healthy adults.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07552467

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.