Epithelial Ovarian CancerPhase 2NCT05284552
Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer
A Phase 2 study testing Tinzaparin Injectable Solution in people with Epithelial Ovarian Cancer, run by University Hospital, Linkoeping at 8 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Tinzaparin Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesSweden
- Study dates
- 12 Jul 2022to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has given written consent to participate in the study.
- Age 18 and above
- Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy indicates an origin from the ovary, fallopian tube or peritoneum.
- Histology diagnosis of either high grade serous carcinoma, endometroid carcinoma or clear cell carcinoma.
- FIGO stage III-IV disease.
- Planned for platinum-based chemotherapy
Show all 11Show fewer
- Prior to start of NACT pregnancy should be ruled out by menstrual history or in unclear cases by a urine hCG test.
- Women of childbearing potential should use a safe birth control method (combined hormonal contraception, progesterone only hormonal contraception, intra uterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence, male or female condom, diaphragm with spermicide).
- WHO Performance Status 0-2
- Weight 50-150 kg
- CA-125-level ≥250 kIE/L at diagnosis
Who cannot join
- Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed.
- Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year.
- Known or suspected allergies against any product included in the study
- Ongoing pregnancy, independent of gestational age. Breastfeeding or planned pregnancy
- EOC disclosed at Cesarean section
- Abdominal surgery or other major surgery within the last year
Show all 25Show fewer
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Treatment or disease which, according to the investigator, can affect treatment or study results
- Known brain metastasis
- Participation or recent participation (within the last 30 days) in a clinical study with an investigational product
- Ongoing treatment of thromboembolic disease.
- Thromboembolic disease within the last year.
- Hypersensitivity to the active substance (tinzaparin) or any of the excipients.
- Serious hemorrhage or conditions predisposing to serious hemorrhage. Serious hemorrhage is defined as fulfilling any one of these three criteria:
- occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome),
- causes a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or
- leads to transfusion of two or more units of whole blood or red blood cells.
- Severe coagulation disorder.
- Acute gastro duodenal ulcer.
- Septic endocarditis.
- Previous heparin-induced thrombocytopenia.
- WHO Performance Status >2.
- E-GFR <30ml/min (analyzed no more than 14 days before start of treatment with investigational product)
- Platelets <100 x10^9/L (analyzed no more than 14 days before start of treatment with investigational product)
- Treatment for other known malignancy within the last year (except basal cell carcinoma)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Sweden8 sites, 7 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Highland Hospital
Eksjö, Eksjö, 575 81
Christopher Allen, MD, +46102410000, christopher.allen@rjl.se
Malena Tiefenthal Thrane, MD
- Recruiting
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Gothenburg, 41345
Karin Bergmark, MD, PhD, +46313421000, Karin.Bergmark@vgregion.se
Karin Bergmark, MD, PhD
- Recruiting
Department of Obstetrics and Gynecology, Ryhov County Hospital
Jönköping, Jönköping County, 55305
Laila Falknäs, MD, +46102410000, laila.falknas@rjl.se
Laila Falknäs, MD
- Recruiting
Department of Oncology, Linköping University Hospital
Linköping, Linköping, 58185
Gabriel Lindahl, MD, PhD, +46101030000, gabriel.lindahl@regionostergotland.se
Gabriel Lindahl, MD, PhD
- Active, not recruiting
Department of Obstetrics and Gynecology, University Hospital
Linköping, Östergötland County, 58185
- Recruiting
Department of Obstetrics and Gynaecology, Norrland University Hospital
Umeå, Umeå, 90719
Ulrika Ottander, MD, PhD, +46907850000, Ulrika.Ottander@umu.se
Ulrika Ottander, MD, PhD
- Recruiting
Department of Obstetrics and Gynecology, Värnamo Hospital
Värnamo, Värnamo, 33152
Shefqet Halili, MD, +46102410000, shefqet.halili@rjl.se
Shefqet Halili, MD
- Recruiting
Department of Obstetrics and Gynecology, Västervik Hospital
Västervik, Västervik, 593 81
Anders Rosenmüller, MD, +4649086000, anders.rosenmuller@regionkalmar.se
Anders Rosenmüller, MD
About this study
Official title: The Effect of Tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy - A Randomized Pilot Study
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).
Read more
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.
Read the detailed description
This is an open randomized controlled clinical pilot trial (Phase II). The study includes women with the International Federation of Obstetrics and Gynecology (FIGO) stage III-IV EOC selected for neoadjuvant chemotherapy (NACT) and without signs of thromboembolic disease or ongoing treatment of thromboembolic disease. The women will be allocated 1:1 to treatment with tinzaparin 4500 IU/8000 IU (dose depending on woman's weight) subcutaneously once daily or no tinzaparin. The treatment group starts tinzaparin when the primary treatment (chemotherapy) starts. The control group will not receive tinzaparin or other low molecular weight heparin preparations. The NACT consists of carboplatin and paclitaxel, given according to the standard regimen with cycle repeats every 21 days. Pre-treatment, before every cycle of chemotherapy, before delayed primary debulking surgery (DPDS) and three weeks after the last cycle of chemotherapy venous blood samples will be taken for measuring the biomarkers hemoglobin, platelets, leucocytes, C-reactive protein (CRP), albumin, cancer antigen-125 (CA-125), Tissue Factor, D-dimer, soluble P-selectin, thrombin-antithrombin complex and thrombin generation potential. Furthermore, a panel of 92 inflammation-associated proteins will be analyzed by a by a high-sensitivity Proximity Extension Assay at baseline, visit 5 and visit 8 or 9. After three cycles of NACT, the patient will be evaluated clinically and with imaging diagnostics in order to determine whether the patient should undergo DPDS. In the investigators´ setting, > 80% of patients receiving NACT for EOC undergo DPDS. After DPDS, all patients will be treated with tinzaparin for 28 days according to clinical practice concerning postoperative thromboembolic prophylaxis and thereafter continue the chemotherapy for additional two-three courses. The participants who were allocated to tinzaparin during the NACT can chose to continue the tinzaparin after ending the postoperative thromboembolic prophylactic tinzaparin treatment for additional 2-3 courses. The biomarkers will be measured preoperatively and four weeks postoperatively after DPDS and then before each course of chemotherapy given during the primary treatment. The women who do not undergo surgery will remain included in the study for the following three cycles of chemotherapy. Thus, the total study period constitutes 22-29 weeks.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Tinzaparin Injectable Solution
- Keywords
- Tinzaparin, Neoadjuvant chemotherapy, FIGO stage III-IV
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tinzaparin Injectable SolutionDrug
Also called Innohep®
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Drug: Tinzaparin (Innohep®), solution for injection. Administration form: Subcutaneous injection. Dosage: 4500 IU (for subjects weighing below 90 kg) or 8000 IU (for subjects weighing 90 kg and above) daily for 21-28 weeks. Receives: Drug: Tinzaparin Injectable Solution |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum levels of CA-125
kIU/L
Measured: 14 weeks
Secondary outcomes (13)
Changes in serum levels of CA-125
kIU/L
Measured: 21-28 weeks
Changes in blood levels of hemoglobin
g/L
Measured: 21-28 weeks
Changes in blood levels of platelets
x10^9/L
Measured: 21-28 weeks
Changes in blood levels of leucocytes
x10^9/L
Measured: 21-28 weeks
Changes in plasma levels of CRP
mg/L
Measured: 21-28 weeks
Changes in plasma levels of albumin
g/L
Measured: 21-28 weeks
Changes in plasma levels of interleukin 6
ng/L
Measured: 21-28 weeks
Changes in plasma levels of vascular endothelial growth factor
µg/L
Measured: 21-28 weeks
Self reported compliance to tinzaparin injections
Percent
Measured: 22-29 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number
Measured: 22-29 weeks
Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0
Proportion constitutes the relative number in the group in percent
Measured: 22-29 weeks
Objectively confirmed venous thromboembolism (VTE), i.e. pulmonary embolism, lower-limb deep vein thrombosis or upper extremity deep vein thrombosis. Death due to VTE.
Number
Measured: 22-29 weeks
Objectively confirmed venous thromboembolism (VTE), i.e. pulmonary embolism, lower-limb deep vein thrombosis or upper extremity deep vein thrombosis. Death due to VTE.
Percent
Measured: 22-29 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start12 Jul 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Region Jönköping County, Västervik Hospital, Vastra Gotaland Region, Region Västerbotten
- Responsible party
- Principal investigator, Preben Kjolhede, MD, professor, University Hospital, Linkoeping
- Investigators
- Preben Kjölhede, MD, PhD, Study chair, University Hospital, LinkoepingGabriel Lindahl, MD, PhD, Study chair, University Hospital, LinkoepingAnna-Clara Spetz Holm, MD, PhD, Study chair, University Hospital, LinkoepingAnna Karlsson, MD, Study chair, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284552
- Sponsor's protocol ID
- The TABANETOC-trial
- Other IDs
- 2024-515450-24-00, 2021-000135-31
- Status last verified
- May 2026
- First submitted
- 6 Feb 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy - A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05284552
- Acronym / sponsor ID
- The TABANETOC-trial
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Tinzaparin, Neoadjuvant chemotherapy, FIGO stage III-IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Region Jönköping County, Västervik Hospital, Vastra Gotaland Region, Region Västerbotten
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open randomized controlled clinical pilot trial (Phase II). The study includes women with the International Federation of Obstetrics and Gynecology (FIGO) stage III-IV EOC selected for neoadjuvant chemotherapy (NACT) and without signs of thromboembolic disease or ongoing treatment of thromboembolic disease. The women will be allocated 1:1 to treatment with tinzaparin 4500 IU/8000 IU (dose depending on woman's weight) subcutaneously once daily or no tinzaparin. The treatment group starts tinzaparin when the primary treatment (chemotherapy) starts. The control group will not receive tinzaparin or other low molecular weight heparin preparations. The NACT consists of carboplatin and paclitaxel, given according to the standard regimen with cycle repeats every 21 days. Pre-treatment, before every cycle of chemotherapy, before delayed primary debulking surgery (DPDS) and three weeks after the last cycle of chemotherapy venous blood samples will be taken for measuring the biomarkers hemoglobin, platelets, leucocytes, C-reactive protein (CRP), albumin, cancer antigen-125 (CA-125), Tissue Factor, D-dimer, soluble P-selectin, thrombin-antithrombin complex and thrombin generation potential. Furthermore, a panel of 92 inflammation-associated proteins will be analyzed by a by a high-sensitivity Proximity Extension Assay at baseline, visit 5 and visit 8 or 9. After three cycles of NACT, the patient will be evaluated clinically and with imaging diagnostics in order to determine whether the patient should undergo DPDS. In the investigators´ setting, > 80% of patients receiving NACT for EOC undergo DPDS. After DPDS, all patients will be treated with tinzaparin for 28 days according to clinical practice concerning postoperative thromboembolic prophylaxis and thereafter continue the chemotherapy for additional two-three courses. The participants who were allocated to tinzaparin during the NACT can chose to continue the tinzaparin after ending the postoperative thromboembolic prophylactic tinzaparin treatment for additional 2-3 courses. The biomarkers will be measured preoperatively and four weeks postoperatively after DPDS and then before each course of chemotherapy given during the primary treatment. The women who do not undergo surgery will remain included in the study for the following three cycles of chemotherapy. Thus, the total study period constitutes 22-29 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Tinzaparin Injectable SolutionDrug: Tinzaparin (Innohep®), solution for injection. Administration form: Subcutaneous injection. Dosage: 4500 IU (for subjects weighing below 90 kg) or 8000 IU (for subjects weighing 90 kg and above) daily for 21-28 weeks. |
| Control Arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subject has given written consent to participate in the study.
- Age 18 and above
- Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy indicates an origin from the ovary, fallopian tube or peritoneum.
- Histology diagnosis of either high grade serous carcinoma, endometroid carcinoma or clear cell carcinoma.
- FIGO stage III-IV disease.
Key exclusion criteria (25 listed)
- Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed.
- Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year.
- Known or suspected allergies against any product included in the study
- Ongoing pregnancy, independent of gestational age. Breastfeeding or planned pregnancy
- EOC disclosed at Cesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tinzaparin Injectable SolutionAlso: Innohep®Subcutaneous injection | Drug | Intervention Arm |
Primary outcome
Changes in serum levels of CA-125
Time frame: 14 weeks
kIU/L
13 secondary outcomes
Changes in serum levels of CA-125
Time frame: 21-28 weeks
Changes in blood levels of hemoglobin
Time frame: 21-28 weeks
Changes in blood levels of platelets
Time frame: 21-28 weeks
Changes in blood levels of leucocytes
Time frame: 21-28 weeks
Changes in plasma levels of CRP
Time frame: 21-28 weeks
Changes in plasma levels of albumin
Time frame: 21-28 weeks
Changes in plasma levels of interleukin 6
Time frame: 21-28 weeks
Changes in plasma levels of vascular endothelial growth factor
Time frame: 21-28 weeks
Self reported compliance to tinzaparin injections
Time frame: 22-29 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 22-29 weeks
Proportion of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 22-29 weeks
Objectively confirmed venous thromboembolism (VTE), i.e. pulmonary embolism, lower-limb deep vein thrombosis or upper extremity deep vein thrombosis. Death due to VTE.
Time frame: 22-29 weeks
Objectively confirmed venous thromboembolism (VTE), i.e. pulmonary embolism, lower-limb deep vein thrombosis or upper extremity deep vein thrombosis. Death due to VTE.
Time frame: 22-29 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Preben Kjölhede, MD, PhD study chair
University Hospital, Linkoeping
Gabriel Lindahl, MD, PhD study chair
University Hospital, Linkoeping
Anna-Clara Spetz Holm, MD, PhD study chair
University Hospital, Linkoeping
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tinzaparin Injectable Solution in people with Epithelial Ovarian Cancer, run by University Hospital, Linkoeping at 8 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Preben Kjölhede, MD, PhD (+46101030000 ext. 3187, preben.kjolhede@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum levels of CA-125 (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.