Actively Recruiting
Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer
Led by University Hospital, Linkoeping · Updated on 2026-05-11
40
Participants Needed
8
Research Sites
281 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Linkoeping
Lead Sponsor
R
Region Jönköping County
Collaborating Sponsor
AI-Summary
What this Trial Is About
Background: Previous findings have indicated antineoplastic properties of tinzaparin (Innohep®), a commonly used anti-coagulant. Earlier studies have mainly investigated the antineoplastic effects of tinzaparin in animal models and in human cell-lines. In this pilot study the aim is to examine the potential antitumoral effects of tinzaparin in vivo in women with epithelial ovarian cancer (EOC). Study objectives: Primary objective: The primary objective of the study is to evaluate the effects of tinzaparin on changes in levels of CA-125 in EOC patients who receive neoadjuvant chemotherapy (NACT). Secondary objectives: The secondary objective of the study is to explore the impact of tinzaparin on the dynamic of a spectrum of immunological and coagulation factors in EOC patients who receive NACT. Besides, the compliance of tinzaparin injections and adverse events caused by tinzaparin will be described.
CONDITIONS
Official Title
Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject has given written consent to participate in the study.
- Age 18 and above
- Diagnosis of epithelial ovarian, fallopian tube, or peritoneal cancer, or abdominal cancer with biopsy indicating origin from these areas.
- Histology diagnosis of high grade serous carcinoma, endometroid carcinoma, or clear cell carcinoma.
- FIGO stage III-IV disease.
- Planned for platinum-based chemotherapy.
- Pregnancy ruled out before starting neoadjuvant chemotherapy by menstrual history or urine hCG test if unclear.
- Women of childbearing potential must use a safe birth control method.
- WHO Performance Status 0-2.
- Weight between 50 and 150 kg.
- CA-125 level of 250 kIE/L or higher at diagnosis.
You will not qualify if you...
- Receiving treatment with heparins, low molecular weight heparins, warfarin, or non-vitamin K antagonist oral anticoagulants; platelet inhibitors are allowed.
- Treated with heparins or similar anticoagulants within the last year.
- Known or suspected allergy to any study product.
- Ongoing pregnancy, breastfeeding, or planned pregnancy.
- EOC discovered during Cesarean section.
- Major abdominal or other surgery within the last year.
- Mental inability, reluctance, or language difficulties affecting understanding of study participation.
- Treatment or disease that may affect study results as judged by the investigator.
- Known brain metastasis.
- Participation in another clinical study with an investigational product within the last 30 days.
- Ongoing treatment for thromboembolic disease.
- Thromboembolic disease within the last year.
- Hypersensitivity to tinzaparin or excipients.
- Serious hemorrhage or conditions predisposing to serious hemorrhage.
- Severe coagulation disorder.
- Acute gastro duodenal ulcer.
- Septic endocarditis.
- Previous heparin-induced thrombocytopenia.
- WHO Performance Status greater than 2.
- Estimated glomerular filtration rate (E-GFR) less than 30 ml/min measured within 14 days before treatment.
- Platelet count less than 100 x 10^9/L measured within 14 days before treatment.
- Treatment for other known malignancy within the last year except basal cell carcinoma.
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Trial Site Locations
Total: 8 locations
1
Department of Obstetrics and Gynecology, Highland Hospital
Eksjö, Eksjö, Sweden, 575 81
Actively Recruiting
2
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Gothenburg, Sweden, 41345
Actively Recruiting
3
Department of Obstetrics and Gynecology, Ryhov County Hospital
Jönköping, Jönköping County, Sweden, 55305
Actively Recruiting
4
Department of Oncology, Linköping University Hospital
Linköping, Linköping, Sweden, 58185
Actively Recruiting
5
Department of Obstetrics and Gynaecology, Norrland University Hospital
Umeå, Umeå, Sweden, 90719
Actively Recruiting
6
Department of Obstetrics and Gynecology, Värnamo Hospital
Värnamo, Värnamo, Sweden, 33152
Actively Recruiting
7
Department of Obstetrics and Gynecology, Västervik Hospital
Västervik, Västervik, Sweden, 593 81
Actively Recruiting
8
Department of Obstetrics and Gynecology, University Hospital
Linköping, Östergötland County, Sweden, 58185
Active, Not Recruiting
Research Team
P
Preben Kjölhede, MD, PhD
CONTACT
A
Anna Karlsson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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