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New triple therapy takes on hard-to-treat ovarian cancer

NCT ID NCT07239622

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests a combination of three drugs—liposomal irinotecan, sintilimab, and anlotinib—in 36 people with recurrent or persistent ovarian clear cell carcinoma. The goal is to see if the treatment can shrink tumors and control the disease. Participants must have already tried platinum-based chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
liposomal irinotecan, sintilimab, and anlotinib
What this could lead to
If successful, this combination could offer a new treatment option for people with recurrent ovarian clear cell carcinoma, potentially shrinking tumors and delaying disease progression.
What could go wrong
This is a small, early-phase trial with only 36 participants and no comparison group. The combination may cause significant side effects, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntarily agrees to participate in the clinical study and signs a written informed consent form. * Age between 18 and 75 years, with histologically confirmed recurrent or persistent ovarian clear cell carcinoma. * Has received at least one prior line of platinum-based chemotherapy. * ECOG performance status of 0-2. * Expected survival greater than 12 weeks. * Has measurable disease as defined by RECIST version 1.1: * Each lesion must measure ≥10 mm in its longest diameter by CT, MRI, or clinical examination; * Lesions measured by chest X-ray must be ≥20 mm; * Lymph nodes must have a short axis ≥15 mm when measured by CT or MRI. * At least 4 weeks have elapsed since the last systemic anticancer therapy. * Hematologic, hepatic, renal, thyroid, and cardiac enzyme tests are within normal limits. Exclusion Criteria: * Non-clear cell histologic subtype of ovarian carcinoma. * Prior treatment with immune checkpoint inhibitors, including PD-1, PD-L1, or CTLA-4 inhibitors. * Contraindications to anlotinib, including but not limited to: history of gastrointestinal perforation; surgery within 28 days before combination therapy or unhealed wounds; severe bleeding or recent hemoptysis; or any other condition deemed unsuitable for anlotinib use by the investigator. * Known allergy to irinotecan, anlotinib, or sintilimab. * Brain metastases requiring surgical intervention. * History of other malignancies within the past 5 years. * Active autoimmune disease within the past 2 years. * Vaccination within 1 month prior to study enrollment. * Blood transfusion or platelet transfusion within 4 weeks before first dosing. * Systemic corticosteroid therapy (excluding topical, inhaled, or intranasal corticosteroids) or any other form of immunosuppressive therapy (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, or anti-TNF agents) within 7 days prior to first dosing. * Use of systemic antitumor traditional Chinese medicine or immunomodulatory agents (e.g., thymosin, interferon, interleukin) within 2 weeks before first dosing, except for local use to control pleural effusion. * Continuous use of aspirin (\>325 mg/day) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function for 10 consecutive days within 10 days before first dosing. * Continuous full-dose oral or parenteral anticoagulant or thrombolytic therapy for 10 consecutive days within 10 days before first dosing. * Hereditary bleeding tendency or coagulation disorder; history of hypertension with thrombosis; tumor invasion of major vessels, or radiologic evidence suggesting risk of bleeding, as determined by the investigator or radiologist. * Presence of serious unhealed wounds, ulcers, or fractures. * History of allogeneic organ transplantation (except corneal transplant) or allogeneic hematopoietic stem cell transplantation. * Known history of human immunodeficiency virus (HIV) infection (positive HIV-1/2 antibodies). * Untreated active hepatitis B infection (defined as HBsAg positive with detectable HBV-DNA copies). * Unresolved toxicities from prior therapy (≥Grade 2), except for alopecia, neuropathy, lymphopenia, or skin depigmentation. * Presence of severe or uncontrolled systemic diseases

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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