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 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.

NCT Number	NCT07586813
Lead Sponsor	Peking University People's Hospital Collaborators: Peking University Cancer Hospital and Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking University International Hospital, Shanxi Province Cancer Hospital, Henan Provincial People's Hospital, China-Japan Union Hospital, Sun Yat-sen University Cancer Center, Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital
Conditions	Persistent Isolated Chemotherapy-Induced Thrombocytopenia, Chemotherapy-Induced Thrombocytopenia, Gastrointestinal Neoplasms, Pancreatic Cancer, Colorectal Cancer
Enrollment	220 participants
Start Date	2025-12-22
Primary Completion	2027-10-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-14