Liposomal Irinotecan Combined With Sintilimab and Anlotinib in the Treatment of Recurrent or Persistent Ovarian Clear Cell Carcinoma

NCT07239622 | Not Yet Recruiting Phase 2

• 1 other identifier: SYSKY-2025-677-01
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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). \*\*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.

Conditions

Ovarian Cancer; Ovarian Clear Cell Carcinoma

Keywords

ovarian cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

Study Arms (1)

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.

Drug: Treatment

Interventions

Treatment DRUG

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Huaiwu Lu

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaiwu Lu

CONTACT

02081332587; luhuaiwu@mail.sysu.edu.cn

Huaiwu Lu

CONTACT

luhuaiwu@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, China.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share