A Multicenter Randomized Controlled Study to Assess the Efficacy and Safety of rhTPO's Prophylactic Treatment of Cancer Treatment-induced Thrombocytopenia in Patients With High Risk of Treatment-induced Cardiac Injury

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

To assess the efficacy and safety of an optimised dosing regimen of rhTPO's prophylactic treatment of cancer treatment-induced thrombocytopenia(CTIT) and to explore the cardioprotective effect of rhTPO in cancer patients with high risk of treatment-induced cardiac injury.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Males or females greater than or equal to 18 years of age at signing of the informed consent.

• Patients clinically judged to be at high risk of CTIT: Patients who had a platelet count below 50×10\^9/L in the past 3 months; or patients who meet the criteria for prophylactic treatment in the Chinese Expert Consensus on the Management of Thrombocytopenia due to Oncology Chemotherapy (2018 Edition).The criteria for prophylactic treatment include: 1) The nadir platelet value in the last chemotherapy cycle was \<50×10\^9/L;Or 2)The patients with nadir platelet value ≥50×10\^9/L and \<75×10\^9/L in the previous chemotherapy cycle also met at least one of the following risk factors for bleeding:

‣ With a previous history of bleeding.

⁃ Chemotherapy regimens containing platinum, gemcitabine, cytarabine, anthracycline, etc.

⁃ Combination regimens containing targeted or chemotherapy drugs which regularly result in thrombocytopenia.

⁃ Thrombocytopenia caused by bone marrow infiltration of tumor cells.

⁃ Eastern Cooperative Oncology Group (ECOG) score ≥2.

⁃ Previous radiotherapy or ongoing radiotherapy, especially for long and flat bones (e.g. pelvis, sternum, etc.).

• Platelet count ≥75×10\^9/L and \<150×10\^9/L, Hemoglobin ≥9.0 g/dL and absolute neutrophils ≥1.5×10\^9 /L during screening.

• Patients with medium and high-risk with cardiotoxicity risk score (CRS) ≥3 and ECOG score of 0, 1, or 2 during screening.

• The current tumor treatment belongs to the scope of neoadjuvant, adjuvant, relapsed metastatic/advanced first-line and second-line therapies, anticipated to receive at least 2 cycles of current regimen with survival ≥ 6 months. The regimens may be 14-day, 21-day or 28-day cycles combined with targeted, immunotherapy, etc.

• Inclusion of organ tumours and lymphomas, with no restriction on the type and stage of organ tumours, etc.

• Patient provided signed informed consent

Locations
Other Locations
China
Anqing Municipal Hospital
RECRUITING
Anqing
Beijing Chaoyang District Sanhuan Cancer Hospital
RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Chinese PLA General Hospital
RECRUITING
Beijing
Peking University Shougang Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Affiliated Tumor Hospital of Nantong University
RECRUITING
Nanyang
Liaoning Cancer Hospital & Institute
RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Tongji Hospital Tongji Medical College of Huazhong University of Science & Technology
NOT_YET_RECRUITING
Wuhan
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Shaanxi Provincial Cancer Hospital
RECRUITING
Xi'an
Henan Cancer Hospital
RECRUITING
Zhengzhou
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jiwei Liu, MD
jiweiliudl@126.com
18098877966
Backup
Fengqi Fang, MD
ffqlj@163.com
18098876723
Time Frame
Start Date: 2022-06-06
Estimated Completion Date: 2024-08
Participants
Target number of participants: 165
Treatments
Experimental: rhTPO
The study in a 2:1 randomization ratio (110 subjects to rhTPO).
Other: Control
The study in a 2:1 randomization ratio (55 subjects to control group).
Related Therapeutic Areas
Sponsors
Collaborators: Hebei Medical University Fourth Hospital, Liaoning Cancer Hospital & Institute, Anqing Municipal Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Beijing Sanhuan Cancer Hospital, Peking University Shougang Hospital, Henan Cancer Hospital, Shaanxi Provincial Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Henan Provincial People's Hospital, Tongji Hospital, Chinese PLA General Hospital, Tianjin Medical University Cancer Institute and Hospital, Bethune Charitable Foundation, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Leads: The First Affiliated Hospital of Dalian Medical University

This content was sourced from clinicaltrials.gov

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