Liposomal Irinotecan Plus Enlonstobart for Platinum-Resistant Recurrent Ovarian Cancer

NCT07591831 | Not Yet Recruiting Phase 2

• 1 other identifier: CSPC-DNY-CC-TJ01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of liposomal irinotecan combined with enlonstobart in patients with platinum-resistant recurrent ovarian cancer. Eligible female participants with histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, FIGO stage II-IV, will receive liposomal irinotecan and enlonstobart every 2 weeks. Tumor assessment will be performed every 8 weeks. Participants may discontinue study treatment in the event of disease progression, intolerable toxicity, withdrawal of consent, or other reasons judged by the investigator.

Conditions

Fallopian Tube Cancers; Primary Peritoneal Cancer; Platinum-resistant Recurrent Ovarian Cancer; Epithelial Ovarian Cancer

Keywords

Platinum-resistant ovarian cancer; Recurrent ovarian cancer; Epithelial ovarian cancer; Fallopian tube cancer; Primary peritoneal cancer; Liposomal irinotecan; Enlonstobart; PD-1 inhibitor; Objective response rate; Progression-free survival; Overall survival

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Objective response rate is defined as the proportion of participants who achieve complete response or partial response according to RECIST version 1.1.

  Every 8 weeks, up to 12 months

Secondary Outcomes (3)

• Progression-Free Survival

  From enrollment to disease progression or death, up to 24 months

• Overall Survival

  From enrollment to death from any cause, up to 24 months

• Incidence and Severity of Adverse Events

  From first dose to 30 days after the last dose, up to 13 months

Study Arms (1)

Experimental: Liposomal Irinotecan Plus Enlonstobart

EXPERIMENTAL

Participants will receive liposomal irinotecan 70 mg/m\^2 by intravenous infusion every 2 weeks and enlonstobart 240 mg by intravenous infusion every 2 weeks. Each treatment cycle is 14 days. Tumor assessment will be performed every 8 weeks, or every 4 cycles. Participants with disease progression or intolerable toxicity may discontinue study treatment and receive other antitumor therapy at the investigator's discretion.

Drug: Liposomal Irinotecan

Interventions

Liposomal Irinotecan DRUG

Liposomal irinotecan 70 mg/m\^2 will be administered by intravenous infusion every 2 weeks.

Experimental: Liposomal Irinotecan Plus Enlonstobart

Eligibility Criteria

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

You may qualify if:

• Female participants aged 18 to 75 years, inclusive, at the time of signing informed consent.
• Histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, FIGO stage II-IV.
• Platinum-resistant recurrent disease, defined as disease progression within 6 months after the last platinum-containing chemotherapy, and not platinum-refractory disease, defined as disease progression within 4 weeks after initial platinum-containing chemotherapy. Participants may have received up to two prior lines of non-platinum systemic therapy. Treatment with a PARP inhibitor or anti-angiogenic therapy after platinum-resistant recurrence will be counted as one line of therapy; maintenance treatment with a PARP inhibitor or anti-angiogenic therapy will not be counted as a treatment line.
• Ability to provide sufficient qualified formalin-fixed paraffin-embedded tumor tissue samples or slides for PD-L1 testing. Participants who are unable to provide tumor tissue slides for certain reasons may be enrolled at the investigator's discretion.
• At least one measurable lesion at baseline according to RECIST version 1.1. The measurable lesion must not have received prior local therapy such as radiotherapy. A lesion located within a previously irradiated area may be selected as a target lesion if disease progression has been confirmed.
• ECOG performance status of 0 or 1.
• Expected survival of at least 3 months.
• Adequate organ function, meeting all of the following criteria without blood transfusion, hematopoietic stimulating factors, or medication correction of blood cell counts within 14 days before the first dose:
• Absolute neutrophil count ≥1.5 × 10\^9/L;
• Platelet count ≥75 × 10\^9/L;
• Hemoglobin ≥9 g/dL;
• Serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥50 mL/min;
• Total bilirubin ≤1.5 × the upper limit of normal, or ≤3 × the upper limit of normal for participants with Gilbert's syndrome;
• Alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal, or ≤5 × the upper limit of normal for participants with liver metastases;
• Activated partial thromboplastin time and international normalized ratio ≤1.5 × the upper limit of normal, without anticoagulants or other drugs affecting coagulation function within 14 days before the first dose, except for participants requiring long-term anticoagulation due to underlying disease.

You may not qualify if:

• History of severe hypersensitivity reaction to monoclonal antibody preparations or uncontrolled allergic asthma.
• Known untreated central nervous system metastases, or treated but still symptomatic central nervous system metastases. Participants with residual signs or symptoms related to central nervous system treatment may be eligible if neurological symptoms have been stable or improved for at least 2 weeks before screening.
• History of primary immunodeficiency.
• Active autoimmune disease or history of autoimmune disease. Participants with well-controlled type 1 diabetes mellitus, well-controlled hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment such as vitiligo, psoriasis, or alopecia, or conditions not expected to recur without external triggers may be eligible for further screening.
• Serious arterial or venous thrombotic events within 3 months before screening, such as transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep venous thrombosis, or pulmonary embolism.
• History of interstitial lung disease, except localized radiation-induced interstitial pneumonia, or noninfectious pneumonia requiring glucocorticoid therapy.
• Prior treatment with any antibody or drug targeting T-cell costimulatory or immune checkpoint pathways, including PD-1, PD-L1, PD-L2, CTLA-4, OX40, or CD137 inhibitors.
• Prior immune-related adverse event of CTCAE version 5.0 Grade 3 or higher after immunotherapy.
• Major surgery or radical radiotherapy within 28 days before the first dose; palliative radiotherapy within 14 days before the first dose; or use of radiopharmaceuticals such as strontium or samarium within 56 days before the first dose.
• Systemic antitumor therapy within 28 days before the first dose, including but not limited to chemotherapy, immunotherapy, macromolecular targeted therapy, or biological therapy such as tumor vaccines, cytokines, or growth factors used to control cancer. Small-molecule targeted therapy or oral fluoropyrimidines within 14 days before the first dose or within 5 half-lives, whichever is longer; or mitomycin C or nitrosoureas within 6 weeks before the first dose.
• Receipt of a live attenuated vaccine within 28 days before the first dose or planned receipt of a live attenuated vaccine during the study.
• Any active infection requiring systemic treatment by intravenous infusion within 28 days before the first dose.
• Treatment within 14 days before the first dose with traditional Chinese patent medicines approved by the NMPA whose package inserts clearly state antitumor indications, or traditional Chinese herbal medicine documented in the medical record as being used for antitumor purposes.
• Whole blood or blood component transfusion within 14 days before the first dose.
• Treatment with glucocorticoids equivalent to prednisone \>10 mg/day or other immunosuppressive agents within 14 days before the first dose.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Interventions

irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 18, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2030
• Last Updated: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication of the main study results and for 5 years thereafter.
• Access Criteria: Data will be available to qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed and approved by the sponsor and principal investigator. Data will be shared after approval of the proposal and signing of a data use agreement.