Ovarian CancerPhase 2NCT07239622
Liposomal Irinotecan Combined With Sintilimab and Anlotinib in the Treatment of Recurrent or Persistent Ovarian Clear Cell Carcinoma
A Phase 2 study testing Treatment in people with Ovarian Cancer and Ovarian Clear Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
Primary Objective: The primary objective of this study is to evaluate the efficacy and safety of liposomal irinotecan in combination with sintilimab and anlotinib in patients with recurrent or persistent ovarian clear cell carcinoma (OCCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Clear Cell Carcinoma
- What is being tested?
- Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2029
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Huaiwu Lu contact
About this study
Official title: Liposomal Irinotecan Combined With Sintilimab and Anlotinib in the Treatment of Recurrent or Persistent Ovarian Clear Cell Carcinoma: A Multicenter, Single-Arm, Phase II Clinical Study
Primary Objective: The primary objective of this study is to evaluate the efficacy and safety of liposomal irinotecan in combination with sintilimab and anlotinib in patients with recurrent or persistent ovarian clear cell carcinoma (OCCC).
Treatment Regimen:
Read more
Participants will receive the following treatment:
- Liposomal irinotecan: Initial dose of 50 mg/m²; if well tolerated, the dose will be increased to 70 mg/m² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle.
- Sintilimab: 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle.
- Anlotinib: 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period.
Follow-up Schedule: Patients will be followed every 3 months during treatment and within the first year after completion of therapy, every 6 months from Year 2 to Year 5, and annually thereafter. Follow-up assessments will include physical examination, laboratory testing, and imaging studies.
Read the detailed description
(1) This study plans to enroll 36 patients with recurrent or persistent ovarian clear cell carcinoma (OCCC). Patients who meet all inclusion criteria and do not meet any exclusion criteria will be enrolled in the study.
(2) Treatment regimen: liposomal irinotecan + sintilimab + anlotinib
- Liposomal irinotecan: Initial dose 50 mg/m²; if well tolerated, increased to 70 mg/m² at the next cycle.
Administered once every 3 weeks (Q3W), intravenous infusion on Day 1 of each cycle.
- Sintilimab: 200 mg, intravenous infusion (30-60 minutes), Day 1 of each cycle.
- Anlotinib: 8 mg orally, starting on Day 1 of each cycle, administered for 2 weeks followed by 1 week off.
Administration sequence: On Day 1 of each cycle, medications are administered in sequence: patients take anlotinib capsules orally while fasting, followed by intravenous infusion of sintilimab. After an interval of at least 30 minutes, liposomal irinotecan is administered intravenously.
Patients will continue treatment until disease progression, unacceptable toxicity, initiation of new anticancer therapy, withdrawal of informed consent, loss to follow-up, death, or other conditions requiring treatment discontinuation per protocol.
If anlotinib must be temporarily or permanently discontinued due to intolerable toxicity during combination therapy, patients may continue sintilimab and liposomal irinotecan until disease progression, unacceptable toxicity, initiation of new therapy, withdrawal of consent, loss to follow-up, death, or termination by the investigator or sponsor.
If sintilimab must be temporarily or permanently discontinued due to intolerable toxicity, patients may continue anlotinib and liposomal irinotecan under the same termination conditions.
If liposomal irinotecan must be temporarily or permanently discontinued due to intolerable toxicity, patients may continue anlotinib and sintilimab under the same termination conditions.
This study aims to evaluate the efficacy and safety of sintilimab combined with anlotinib and liposomal irinotecan in patients with histologically confirmed platinum-resistant recurrent or persistent OCCC.
After completing all patient evaluations, a trained study coordinator will introduce the study protocol to potentially eligible participants and provide counseling. Patients who voluntarily agree to participate will be informed of all study details, after which written informed consent will be obtained. Baseline characteristics will be collected from all consented patients, who will then receive sintilimab, anlotinib, and liposomal irinotecan therapy. Subsequent treatment will follow standard clinical practice.
After completion of treatment, patients will be followed every 3 months during the first year, every 6 months during years 2-5, and annually thereafter. Follow-up assessments will be conducted during each scheduled visit.
- Conditions
- Ovarian Cancer, Ovarian Clear Cell Carcinoma
- Being tested
- Treatment
- Keywords
- ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDrug
Participants will receive the following treatment:
Liposomal irinotecan: Initial dose of 50 mg/m²; if well tolerated, the dose will be increased to 70 mg/m² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle.
Sintilimab: 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle.
Anlotinib: 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment Regimen:
Participants will receive the following treatment:
* Liposomal irinotecan: Initial dose of 50 mg/m²; if well tolerated, the dose will be increased to 70 mg/m² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle.
* Sintilimab: 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle.
* Anlotinib: 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period. Receives: Drug: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients whose tumors have shrunk to a predefined extent, including cases achieving complete response (CR) or partial response (PR). Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measurable lesions will be documented before treatment initiation, and tumor assessments will be performed every two treatment cycles to evaluate changes until disease progression or treatment discontinuation.
According to RECIST v1.1, treatment response will be categorized as:
Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions or the appearance of new lesions.
Measured: Patients will be followed every 3 months during treatment and up to 1 year after treatment completion, every 6 months from Year 2 to Year 5, and annually thereafter (up to 6 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Huaiwu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Huaiwu Lu, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239622
- Sponsor's protocol ID
- SYSKY-2025-677-01
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Irinotecan Combined With Sintilimab and Anlotinib in the Treatment of Recurrent or Persistent Ovarian Clear Cell Carcinoma: A Multicenter, Single-Arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07239622
- Acronym / sponsor ID
- SYSKY-2025-677-01
- Conditions
- Ovarian Cancer, Ovarian Clear Cell Carcinoma
- Keywords
- ovarian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Nov 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.
Primary Objective: The primary objective of this study is to evaluate the efficacy and safety of liposomal irinotecan in combination with sintilimab and anlotinib in patients with recurrent or persistent ovarian clear cell carcinoma (OCCC).
Treatment Regimen:
Participants will receive the following treatment:
- Liposomal irinotecan: Initial dose of 50 mg/m²; if well tolerated, the dose will be increased to 70 mg/m² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle.
- Sintilimab: 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle.
- Anlotinib: 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period.
Follow-up Schedule: Patients will be followed every 3 months during treatment and within the first year after completion of therapy, every 6 months from Year 2 to Year 5, and annually thereafter. Follow-up assessments will include physical examination, laboratory testing, and imaging studies.
Detailed description
(1) This study plans to enroll 36 patients with recurrent or persistent ovarian clear cell carcinoma (OCCC). Patients who meet all inclusion criteria and do not meet any exclusion criteria will be enrolled in the study.
(2) Treatment regimen: liposomal irinotecan + sintilimab + anlotinib
- Liposomal irinotecan: Initial dose 50 mg/m²; if well tolerated, increased to 70 mg/m² at the next cycle.
Administered once every 3 weeks (Q3W), intravenous infusion on Day 1 of each cycle.
- Sintilimab: 200 mg, intravenous infusion (30-60 minutes), Day 1 of each cycle.
- Anlotinib: 8 mg orally, starting on Day 1 of each cycle, administered for 2 weeks followed by 1 week off.
Administration sequence: On Day 1 of each cycle, medications are administered in sequence: patients take anlotinib capsules orally while fasting, followed by intravenous infusion of sintilimab. After an interval of at least 30 minutes, liposomal irinotecan is administered intravenously.
Patients will continue treatment until disease progression, unacceptable toxicity, initiation of new anticancer therapy, withdrawal of informed consent, loss to follow-up, death, or other conditions requiring treatment discontinuation per protocol.
If anlotinib must be temporarily or permanently discontinued due to intolerable toxicity during combination therapy, patients may continue sintilimab and liposomal irinotecan until disease progression, unacceptable toxicity, initiation of new therapy, withdrawal of consent, loss to follow-up, death, or termination by the investigator or sponsor.
If sintilimab must be temporarily or permanently discontinued due to intolerable toxicity, patients may continue anlotinib and liposomal irinotecan under the same termination conditions.
If liposomal irinotecan must be temporarily or permanently discontinued due to intolerable toxicity, patients may continue anlotinib and sintilimab under the same termination conditions.
This study aims to evaluate the efficacy and safety of sintilimab combined with anlotinib and liposomal irinotecan in patients with histologically confirmed platinum-resistant recurrent or persistent OCCC.
After completing all patient evaluations, a trained study coordinator will introduce the study protocol to potentially eligible participants and provide counseling. Patients who voluntarily agree to participate will be informed of all study details, after which written informed consent will be obtained. Baseline characteristics will be collected from all consented patients, who will then receive sintilimab, anlotinib, and liposomal irinotecan therapy. Subsequent treatment will follow standard clinical practice.
After completion of treatment, patients will be followed every 3 months during the first year, every 6 months during years 2-5, and annually thereafter. Follow-up assessments will be conducted during each scheduled visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: TreatmentTreatment Regimen: Participants will receive the following treatment: * Liposomal irinotecan: Initial dose of 50 mg/m²; if well tolerated, the dose will be increased to 70 mg/m² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle. * Sintilimab: 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle. * Anlotinib: 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
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 |
|---|---|---|
| TreatmentParticipants will receive the following treatment: Liposomal irinotecan: Initial dose of 50 mg/m²; if well tolerated, the dose will be increased to 70 mg/m² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle. Sintilimab: 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle. Anlotinib: 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period. | Drug | Treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: Patients will be followed every 3 months during treatment and up to 1 year after treatment completion, every 6 months from Year 2 to Year 5, and annually thereafter (up to 6 years).
ORR is defined as the proportion of patients whose tumors have shrunk to a predefined extent, including cases achieving complete response (CR) or partial response (PR). Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Measurable lesions will be documented before treatment initiation, and tumor assessments will be performed every two treatment cycles to evaluate changes until disease progression or treatment discontinuation. According to RECIST v1.1, treatment response will be categorized as: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions or the appearance of new lesions.
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 20 Nov 2025.
- 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.
Huaiwu Lu contact
Huaiwu Lu principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment in people with Ovarian Cancer and Ovarian Clear Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 20 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: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Huaiwu Lu (02081332587, luhuaiwu@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Patients will be followed every 3 months during treatment and up to 1 year after treatment completion, every 6 months from Year 2 to Year 5, and annually thereafter (up to 6 years).). 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 20 Nov 2025.