New triple therapy takes on hard-to-treat ovarian cancer
NCT ID NCT07239622
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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