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

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 thr

Trial Details

NCT ID
NCT07586813
Phase
PHASE2
Sponsor
Peking University People's Hospital
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Romiplostim N01
  • All-trans retinoic acid
Locations (sample)
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • Age 18 years or older.
  • Prior diagnosis of a gastrointestinal/digestive system solid tumor, including but not limited to gastrointestinal tract, pancreatic, or colorectal …
  • Complete remission of the underlying tumor after chemotherapy or antitumor treatment, with tumor-related treatment discontinued for at least 12 wee…
  • Persistent isolated chemotherapy-induced thrombocytopenia, defined as platelet count \<30 x 10\^9/L on two peripheral blood tests at least 7 days a…

For full eligibility, visit ClinicalTrials.gov.

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