Ovarian CancerNCT06977594
Proactive Immune Tolerance Induction in Chemotherapy for Gynecologic Cancer
A study testing Proactive immune tolerance induction, Standard Treatment and Paclitaxel and carboplatin in people with Ovarian Cancer and Endometrial Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of proactive immune tolerance induction of chemotherapy (paclitaxel and carboplatin) for patients with gynecologic cancer. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer
- What is being tested?
- Proactive immune tolerance induction, Standard Treatment and Paclitaxel and carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2025to 31 May 2028
- Phase
- Interventional
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving paclitaxel and carboplatin chemotherapy for gynecologic malignancies.
- Patients with no prior history of hypersensitivity reactions to paclitaxel or carboplatin.
- Patients who are able to read and voluntarily provide written informed consent.
- Aged 19 years or older.
Who cannot join
- Patients who do not wish to participate in this study voluntarily.
- Patients who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hye-Ryun Kang, MD, PhD, +82-2-2072-0820, helenmed@snu.ac.kr
About this study
Official title: A Randomized, Placebo-controlled, Parallel-group, Open-label Trial to Evaluate the Efficacy of Proactive Immune Tolerance Induction to Paclitaxel and Carboplatin in Patients With Gynecologic Cancer
The goal of this clinical trial is to evaluate the efficacy of proactive immune tolerance induction of chemotherapy (paclitaxel and carboplatin) for patients with gynecologic cancer.
The main questions it aims to answer are:
Read more
- Does immune tolerance induction during the first three cycles of chemotherapy reduce the incidence of hypersensitivity reactions in the remaining cycles?
Participants will:
- Undergo immune tolerance induction or standard treatment during the first three cycles of chemotherapy as randomized, after which all participants will continue the remaining cycles with standard treatment.
- Receive a reduced dose of dexamethasone premedication if assigned to the experimental group, depending on the specific protocol of each clinical trial.
Read the detailed description
Proactive immune tolerance induction is applied using an automated infusion pump with a pre-programmed protocol. It follows the same stepwise dosing scheme as conventional desensitization therapy used in patients who have experienced hypersensitivity reactions before. However, it is uniquely performed in patients without a prior history of hypersensitivity reactions, aiming to prevent sensitization itself.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer
- Being tested
- Proactive immune tolerance induction, Standard Treatment, Paclitaxel and carboplatin, Standard premedication (20 mg), Reduced premedication (10 mg)
- Keywords
- Immune tolerance induction, Desensitization, Drug hypersensitivity, Chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive immune tolerance inductionOther
Proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles
Standard TreatmentOther
Standard treatment throughout all chemotherapy cycles
Paclitaxel and carboplatinDrug
A chemotherapy regimen for gynecologic cancers.
Standard premedication (20 mg)Drug
Premedication includes 20 mg of dexamethasone.
Reduced premedication (10 mg)Drug
Premedication includes 20 mg of dexamethasone.
Reduced premedication (5 mg)Drug
Premedication includes 5 mg of dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| (Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication | Experimental | Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 20 mg of dexamethasone. Receives: Other: Proactive immune tolerance induction; Drug: Paclitaxel and carboplatin; Drug: Standard premedication (20 mg) |
| (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication | Active comparator | Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone. Receives: Other: Standard Treatment; Drug: Paclitaxel and carboplatin; Drug: Standard premedication (20 mg) |
| (Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication | Experimental | Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 10 mg of dexamethasone. Receives: Other: Proactive immune tolerance induction; Drug: Paclitaxel and carboplatin; Drug: Reduced premedication (10 mg) |
| (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication | Active comparator | Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone. Receives: Other: Standard Treatment; Drug: Paclitaxel and carboplatin; Drug: Standard premedication (20 mg) |
| (Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication | Experimental | Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 5 mg of dexamethasone. Receives: Other: Proactive immune tolerance induction; Drug: Paclitaxel and carboplatin; Drug: Reduced premedication (5 mg) |
| (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication | Active comparator | Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone. Receives: Other: Standard Treatment; Drug: Paclitaxel and carboplatin; Drug: Standard premedication (20 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity reaction incidence
Hypersensitivity reaction incidence (%) is calculated as (number of hypersensitivity reaction cases / total chemotherapy administrations) × 100.
Hypersensitivity reaction will be defined as a Grade ≥2 event according to Common Terminology Criteria for Adverse Events (CTCAE), or a moderate or higher event according to Brown's criteria.
Measured: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).
Secondary outcomes (6)
Chemotherapy completion rate
Chemotherapy completion rate is defined as the proportion of patients who completed all planned chemotherapy cycles as originally scheduled at treatment initiation.
Measured: From chemotherapy initiation to the last cycle in each patient, an average of 6 months
Severity of hypersensitivity reaction
Severity of hypersensitivity reactions will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).
Patients' quality of life
Patients' quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores range from 0 to 100. Higher scores indicate better outcomes for the Global Health Status and Functional Scales, whereas higher scores on the Symptom Scales indicate worse symptoms.
Measured: From chemotherapy initiation to the last cycle, an average of 6 months
Tumor Response Rate
Tumor response rate is defined as the proportion of patients who experience tumor size reduction or disappearance in response to chemotherapy. It is calculated as the proportion of patients who achieve a complete response (disappearance of all tumors with no evidence of new lesions) or a partial response (at least a 30% reduction in the size of tumors, with no appearance of new lesion) after planned chemotherapy.
Measured: At every third chemotherapy cycle in each patient
Survival rate
Survival rate is defined as the proportion of patients who remain alive, with or without disease, after completion of the planned chemotherapy.
Measured: At study completion in each patient, an average of 1 year
Recurrence Rate
Recurrence rate is defined as the proportion of patients who experience a return of disease after achieving a response to treatment.
Measured: At study completion in each patient, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start21 May 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo-controlled, parallel-group, open-label, clinical trial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Korea Health Industry Development Institute
- Responsible party
- Principal investigator, Hye-Ryun Kang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977594
- Sponsor's protocol ID
- PINTO_C
- Status last verified
- Oct 2026
- First submitted
- 3 May 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to institutional policies regarding data confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Parallel-group, Open-label Trial to Evaluate the Efficacy of Proactive Immune Tolerance Induction to Paclitaxel and Carboplatin in Patients With Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT06977594
- Acronym / sponsor ID
- PINTO_C
- Conditions
- Ovarian Cancer, Endometrial Cancer, Cervical Cancer
- Keywords
- Immune tolerance induction, Desensitization, Drug hypersensitivity, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, Korea Health Industry Development Institute
- Study start
- 21 May 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 18 May 2025 (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.
The goal of this clinical trial is to evaluate the efficacy of proactive immune tolerance induction of chemotherapy (paclitaxel and carboplatin) for patients with gynecologic cancer.
The main questions it aims to answer are:
- Does immune tolerance induction during the first three cycles of chemotherapy reduce the incidence of hypersensitivity reactions in the remaining cycles?
Participants will:
- Undergo immune tolerance induction or standard treatment during the first three cycles of chemotherapy as randomized, after which all participants will continue the remaining cycles with standard treatment.
- Receive a reduced dose of dexamethasone premedication if assigned to the experimental group, depending on the specific protocol of each clinical trial.
Detailed description
Proactive immune tolerance induction is applied using an automated infusion pump with a pre-programmed protocol. It follows the same stepwise dosing scheme as conventional desensitization therapy used in patients who have experienced hypersensitivity reactions before. However, it is uniquely performed in patients without a prior history of hypersensitivity reactions, aiming to prevent sensitization itself.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- A randomized, placebo-controlled, parallel-group, open-label, clinical trial
| Arm | Type | Receives |
|---|---|---|
| (Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication | Experimental | Other: Proactive immune tolerance induction, Drug: Paclitaxel and carboplatin, Drug: Standard premedication (20 mg)Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 20 mg of dexamethasone. |
| (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication | Active comparator | Other: Standard Treatment, Drug: Paclitaxel and carboplatin, Drug: Standard premedication (20 mg)Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone. |
| (Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication | Experimental | Other: Proactive immune tolerance induction, Drug: Paclitaxel and carboplatin, Drug: Reduced premedication (10 mg)Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 10 mg of dexamethasone. |
| (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication | Active comparator | Other: Standard Treatment, Drug: Paclitaxel and carboplatin, Drug: Standard premedication (20 mg)Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone. |
| (Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication | Experimental | Other: Proactive immune tolerance induction, Drug: Paclitaxel and carboplatin, Drug: Reduced premedication (5 mg)Participants will receive proactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles. Premedication includes 5 mg of dexamethasone. |
| (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication | Active comparator | Other: Standard Treatment, Drug: Paclitaxel and carboplatin, Drug: Standard premedication (20 mg)Participants will receive standard treatment throughout all chemotherapy cycles. Premedication includes 20 mg of dexamethasone. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving paclitaxel and carboplatin chemotherapy for gynecologic malignancies.
- Patients with no prior history of hypersensitivity reactions to paclitaxel or carboplatin.
- Patients who are able to read and voluntarily provide written informed consent.
- Aged 19 years or older.
Key exclusion criteria (2 listed)
- Patients who do not wish to participate in this study voluntarily.
- Patients who, in the opinion of the investigator, are unsuitable for participation in this clinical trial.
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 |
|---|---|---|
| Proactive immune tolerance inductionProactive immune tolerance induction during the first three cycles of chemotherapy, followed by standard treatment in the remaining cycles | Other | (Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication, (Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication, (Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication |
| Standard TreatmentStandard treatment throughout all chemotherapy cycles | Other | (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication, (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication, (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication |
| Paclitaxel and carboplatinA chemotherapy regimen for gynecologic cancers. | Drug | (Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication, (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication, (Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication, (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication, (Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication, (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication |
| Standard premedication (20 mg)Premedication includes 20 mg of dexamethasone. | Drug | (Trial 1) Proactive immune tolerance induction with 20 mg dexamethasone as premedication, (Trial 1) Standard treatment (placebo) with 20 mg dexamethasone as premedication, (Trial 2) Standard treatment (placebo) with 20 mg dexamethasone as premedication, (Trial 3) Standard treatment (placebo) with 20 mg dexamethasone as premedication |
| Reduced premedication (10 mg)Premedication includes 20 mg of dexamethasone. | Drug | (Trial 2) Proactive immune tolerance induction with 10 mg dexamethasone as premedication |
| Reduced premedication (5 mg)Premedication includes 5 mg of dexamethasone. | Drug | (Trial 3) Proactive immune tolerance induction with 5 mg dexamethasone as premedication |
Primary outcome
Hypersensitivity reaction incidence
Time frame: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).
Hypersensitivity reaction incidence (%) is calculated as (number of hypersensitivity reaction cases / total chemotherapy administrations) × 100. Hypersensitivity reaction will be defined as a Grade ≥2 event according to Common Terminology Criteria for Adverse Events (CTCAE), or a moderate or higher event according to Brown's criteria.
6 secondary outcomes
Chemotherapy completion rate
Time frame: From chemotherapy initiation to the last cycle in each patient, an average of 6 months
Severity of hypersensitivity reaction
Time frame: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).
Patients' quality of life
Time frame: From chemotherapy initiation to the last cycle, an average of 6 months
Tumor Response Rate
Time frame: At every third chemotherapy cycle in each patient
Survival rate
Time frame: At study completion in each patient, an average of 1 year
Recurrence Rate
Time frame: At study completion in each patient, an average of 1 year
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 7 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to institutional policies regarding data confidentiality.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive immune tolerance induction, Standard Treatment and Paclitaxel and carboplatin in people with Ovarian Cancer and Endometrial Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 2 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
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 Hye-Ryun Kang, MD, PhD (+82-2-2072-0820, helenmed@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypersensitivity reaction incidence (time frame: From the initiation of each chemotherapy cycle to 2 weeks after its administration in each patient (to identify not only immediate but also delayed hypersensitivity reactions).). 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 7 Oct 2026.