Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors
Recruiting
Phase 2
Interventional Study
Persistent Isolated Chemotherapy-Induced Thrombocytopenia
Chemotherapy-Induced Thrombocytopenia
Gastrointestinal Neoplasms
Pancreatic Cancer
Colorectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 220 (estimated)
- Sponsor
- Peking University People's Hospital · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 t…
Contacts