Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing whether adding oral all-trans retinoic acid (ATRA), a drug that can influence blood-cell development, improves recovery from persistent chemotherapy-induced low platelets when combined with romiplostim N01, compared with romiplostim N01 alone. Participants are adults whose gastrointestinal, pancreatic or colorectal cancer is in complete remission but whose platelet counts remain low after chemotherapy.
The comparison asks whether the combination produces a higher platelet response by week 12 than romiplostim alone, with responses defined mainly by reaching a platelet count above 50 × 10⁹/L on at least two of the last three assessments. The researchers will also examine whether responses last, reduce platelet transfusions and bleeding, and remain safe.
Worth knowing: This trial measures platelet recovery and related complications, not whether the cancer stays away or whether people live longer.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07586813 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 220 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Peking University People's Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Romiplostim N01
- Drug All-trans retinoic acid
What it is measuring
Overall Platelet Response Rate at Week 12
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07586813, registered by Peking University People's Hospital on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.