Comparison of Interleukin-11 and rhTPO for Recurrent Colorectal Cancer Patients With Thrombocytopenia

Sponsor
Fudan University
Study ID
NCT03823079
Phase
PHASE2
Status
Unknown

Conditions

  • Recurrent Colorectal Carcinoma
  • Thrombopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rhTPO — DRUG
    rhTPO 300u/kg, subcutaneous injection, qd
  • irinotecan — DRUG
    80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)
  • Raltitrexed — DRUG
    3mg/m2 q3w
  • radiotherapy — RADIATION
    in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.
  • rhIL-11 — DRUG
    rhIL-11 50ug/kg, subcutaneous injection, qd

Study Details

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.

Key Dates

Start date
Feb 1, 2019
Status verified
Jan 2019
Primary completion
Sep 1, 2019
Completion
Feb 1, 2020

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: rhTPO arm
    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
  • Active Comparator: rhIL-11 arm
    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

Primary Outcome Measure

the rate of recovery of platelet accounts [ Time Frame: From date of chemoradiation until the date of first documented recovery, assessed up to 6 months ]

Central Contacts

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