Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors

What Was Tested

The trial (phase 2) is built around Romiplostim for pancreatitis (after the acute phase).

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.

It had two arms (groups): Romiplostim N01 Plus ATRA (experimental) and Romiplostim N01 Alone (active comparator).

The registry classes the interventions as drug.

More on the Plan

In some patients, thrombocytopenia persists after completion of chemotherapy despite complete remission of the underlying tumor.

Persistent isolated chemotherapy-induced thrombocytopenia (PICIT) is characterized by prolonged thrombocytopenia with relatively preserved red blood cell and neutrophil counts, after exclusion of other causes of thrombocytopenia.

Romiplostim N01 is a thrombopoietin receptor agonist intended to stimulate megakaryocyte proliferation and platelet production.

All-trans retinoic acid (ATRA) may provide additional hematopoietic and immunomodulatory effects.

Who Took Part

Enrollment: 220 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 years or older. Thrombocytopenia has persisted since the last chemotherapy treatment without a clear trend of spontaneous recovery. No prior use of Romiplostim N01. Ability to understand and sign the informed consent form and willingness to comply with study visits and procedures.

The full record lists 13 inclusion and 8 exclusion criteria; among the exclusions: active recurrence or progression of the underlying tumor, or evidence of bone marrow metastasis or tumor cell infiltration on bone marrow examination; uncontrolled chronic viral infection, including hepatitis b, hepatitis c, or hiv infection, or active severe infection at screening or within 4 weeks before screening; severe cardiac, hepatic, renal, or other organ dysfunction, or any serious organic disease that would make the participant unable to tolerate study treatment.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Romiplostim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the pancreatitis (after the acute phase) participants stayed in one arm throughout.

Nothing was hidden in this open-label Romiplostim study: the pancreatitis (after the acute phase) participants and staff both knew the treatment.

It started in 2025-12-22 with completion listed for 2027-10-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Overall Platelet Response Rate at Week 12 (time frame: From randomization to Week 12).

It also tracked 10 secondary outcomes, for example Sustained Platelet Response Rate During Weeks 13 to 24, Complete Response Rate, Partial Response Rate, Duration of Response, Time to Response and Change in Platelet Count Over Time.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Romiplostim in 220 people with pancreatitis (after the acute phase).

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, Pancreatitis (after the acute phase) research.