This is a single-center, single-arm clinical study to evaluate the efficacy and safety of iparomlimab and tovorilimab (QL1706) combined with paclitaxel, carboplatin, and bevacizumab as neoadjuvant therapy for advanced ovarian cancer.
Female, aged 18-75 years.
Histologically confirmed high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal adenocarcinoma.
FIGO stage III-IV unresectable ovarian cancer.
Life expectancy ≥16 weeks.
Non-epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (e.g., germ cell tumors), as well as ovarian tumors of low malignant potential (e.g., borderline ovarian tumors).
Prior immunotherapy, including immune checkpoint inhibitory antibodies (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, etc.), immune checkpoint agonistic antibodies (e.g., anti-ICOS, anti-CD40, anti-CD137, anti-GITR, anti-OX40 antibodies, etc.), and immune cell therapy.
Known hypersensitivity to large molecule protein preparations. Contraindications or allergy to any component of iparomlimab and tovorilimab (QL1706), paclitaxel, or carboplatin.
Major surgery (excluding diagnostic laparoscopy; local surgical treatment of isolated lesions is acceptable) within 28 days before the first dose.
Single group
Iparomlimab and Tuvonralimab Injection + Bevacizumab + Paclitaxel + Carboplatin
DrugPaclitaxel: 135\~175 mg/m², IV, on day 1, every 3 weeks (q3w). Carboplatin: AUC 5, IV, on day 1, every 3 weeks (q3w). Iparomlimab and Tuvonralimab (QL1706): 5 mg/kg, IV infusion over at least 30 minutes on day 1, repeated every 3 weeks. Bevacizumab: 7.5mg/kg, IV infusion over 30-90 minutes on day 1, every 3 weeks (q3w).
R0 resection rate
Defined as the percentage of subjects who achieve complete resection (R0) after receiving neoadjuvant therapy.
Objective response rate (ORR)
Defined as the percentage of subjects achieving complete response (CR) or partial response (PR).
pathological complete response (pCR)
Histological examination of the entire surgically resected specimen after neoadjuvant therapy confirms the absence of viable tumor cells on all slides and negative lymph node metastasis.
Progression-Free Survival (PFS)
Defined as the time from enrollment to the date of first documented tumor progression (as assessed RECIST v1.1 criteria, regardless of whether treatment is continued) or death from any cause, whichever occurs first.
Overall Survival (OS)
Defined as the time from the initiation of treatment until death from any cause.
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