As one of the gynecological malignancies with the highest incidence and mortality rates worldwide, ovarian cancer treatment faces the significant challenge of platinum-resistant recurrence. Patients with platinum-resistant recurrent ovarian cancer (PROC) have an extremely poor prognosis, and the survival benefits of traditional chemotherapy and bevacizumab combination therapy are limited (median progression-free survival \[mPFS\] is approximately 2-5 months, and 5-year survival rate is 30%-40%). In recent years, the antibody-drug conjugate (ADC) Sacituzumab tirumotecan has shown breakthrough potential. A phase Ⅱ study presented at the 2024 European Society for Medical Oncology (ESMO) Congress demonstrated that for patients with advanced platinum-resistant ovarian cancer (87.5% of whom had platinum resistance) treated with this drug as monotherapy, the objective response rate (ORR) reached 40%, median progression-free survival (mPFS) was 6.0 months, and disease control rate (DCR) was 75%. Furthermore, the ORR increased to 61.5% in patients with high Trop2 expression, and the safety profile was manageable.Based on the preclinical model evidence suggesting that anti-angiogenic drugs can enhance the intratumoral penetration of ADCs, the current study further explores the synergistic effect of Sacituzumab tirumotecan combined with bevacizumab. It aims to improve therapeutic efficacy by optimizing tumor microcirculation and analyze the molecular mechanisms using technologies such as organoids and single-cell sequencing, thereby providing a new strategy to overcome the bottleneck of platinum resistance.
1.Sign a written informed consent form before undergoing any trial-related procedures;
2.Female, aged ≥ 18 years;
3.Histologically confirmed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer; with platinum resistance (recurrence within 6 months after the last platinum dose);
4.Enrolled subjects must have received at least one but no more than three prior systemic treatment regimens, and the prior regimens may include bevacizumab and/or poly(ADP-ribose) polymerase inhibitors (PARPi);
1.Diagnosis of other malignant diseases within 5 years before the first dose (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ with radical resection);
2.Known presence of active bleeding signs in lesions as shown by endoscopy;
3.Currently participating in therapeutic intervention clinical research, or having received other study drugs or treatment with study devices within 4 weeks before the first dose;
4.Previous receipt of the following therapies: ADC drugs targeting FR-α, or TROP2-targeted treatments (such as any drug therapy containing topoisomerase I targeting agents, including antibody-drug conjugate (ADC) therapy);
Single group
Sacituzumab Tirumotecan Combined with Bevacizumab
DrugSacituzumab Tirumotecan is administered at a dose of 4 mg/kg via intravenous infusion, with a treatment cycle of every 2 weeks, and is given once on Day 1 of each cycle. Bevacizumab is administered at a dose of 7.5\~15 mg/kg via intravenous infusion, once every 3 weeks. Treatment is continued until disease progression or the occurrence of intolerable toxicity.
ORR
ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.
PFS
PFS is defined as the time from the first administration to the first documented progressive disease (PD) per RECIST 1.1 by investigators or death due to any cause, whichever occurs first.
OS
OS is defined as the time from the first receipt of treatment under the study protocol to the death of the subject due to any reason.
Adverse Events (AEs)
The number of participants experiencing an AE will be assessed
Correlation between Trop2 expression, TMB level, immune cell subsets, tumor microenvironment, etc. in tumor tissues and therapeutic efficacy
Correlation between Trop2 expression, TMB level, immune cell subsets, tumor microenvironment, etc. in tumor tissues and therapeutic efficacy
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