Clinical trial · Interventional
Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia
A Randomized Phase II Study of Recombinant Human Thrombopoietin (Rh-TPO) and Recombinant Human Interleukin-11 (rhIL-11) for Recurrent Colorectal Cancer (CRC) Patients With Thrombocytopenia
NCT03823079CI-TRIAL-00036835unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized controlled clinical phase II study was designed to compare the effect of rhTPO with rhIL-11 in improving thrombocytopenia in patients with recurrent colorectal cancer who underwent radiotherapy and with thrombocytopenia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Thrombopenia | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan | Drug | Irinotecan | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
| Raltitrexed | Drug | Raltitrexed | ALIAS |
| rhIL-11 | Drug | — | UNRESOLVED |
| rhTPO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- rhTPO arm
- description
- rhTPO: 300 u/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal) Concurrent Chemoradiotherapy: Radiation: judged according to the tumor site and radiotherapy purpose. Irinotecan: 80 mg/m2 (UGT1A1\*28 6/6) or 65 mg/m2 (UGT1A1\*28 6/7) Raltitrexed: 3 mg/m2 q3w
- interventionNames
- Drug: rhTPO
- Drug: irinotecan
- Drug: Raltitrexed
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- rhIL-11 arm
- description
- rhIL-11: 50 ug/kg, subcutaneous injection, per day. (stopped as soon as the platelet count rises to normal) Concurrent Chemoradiotherapy: Radiation: judged according to the tumor site and radiotherapy purpose. Irinotecan: 80 mg/m2 (UGT1A1\*28 6/6) or 65 mg/m2 (UGT1A1\*28 6/7) Raltitrexed: 3 mg/m2 q3w
- interventionNames
- Drug: irinotecan
- Drug: Raltitrexed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The primary tumor is colorectal cancer, histologically proved recurrence or metastasis disease, or pelvic relapse within 6 months after oxaliplatin-based adjuvant chemotherapy. * Not suitable for re-use of oxaliplatin and fluorouracil. * No medication history of irinotecan. * Lesions evaluable, and has indications for radiotherapy. * UGT1A1\*28 gene phenotype is 6/6 or 6/7 * Karnofsky physical condition score ≥ 70 * Baseline platelet counts are 25-75×10\^9/L, other bone marrow reserve and liver and kidney function meet the requirements of radiotherapy * Able to follow the program during the study period * Sign the informed consent Exclusion Criteria: * Pregnant or breastfeeding women * Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ * If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance. * Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months * Organ transplantation requires immunosuppressive therapy * Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases * Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / L * Anyone who is allergic to any research medication
References
Publications (0)
Data not yet available
No reference posted for this study.