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QL1706 Combined With Chemotherapy and Anlotinib for the Treatment of Recurrent Ovarian Cancer
Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Summary
Ovarian cancer is one of the most common gynecologic malignancies, with considerable histologic heterogeneity; more than 90 % of cases are epithelial ovarian cancers. Because no reliable tools exist for early detection, approximately 70 % of patients are diagnosed at an advanced stage and have poor prognosis, and \>70 % experience relapse within 3 years of initial treatment. The standard first-line strategy combines cytoreductive surgery, platinum-based chemotherapy, and maintenance with PARP inhibitors. Management of recurrent disease remains one of the most challenging problems in clinical oncology. Bevacizumab, a recombinant humanized anti-VEGF monoclonal antibody that blocks endothelial proliferation and neovascularization, is the prototypic angiogenesis inhibitor used in ovarian cancer. However, randomized trials have demonstrated only progression-free survival (PFS) benefit, with no overall survival (OS) advantage. Pre-clinical data suggest that immunotherapy and anti-angiogenic agents can exert synergistic anti-tumor activity, yet clinical efforts combining bevacizumab with immune-checkpoint inhibitors in recurrent ovarian cancer-whether added to platinum-based chemotherapy, used as maintenance, or evaluated in chemotherapy-free regimens-have thus far been unsuccessful (except in clear-cell histology). Anlotinib is a novel oral multi-target tyrosine-kinase inhibitor that blocks VEGFR-2/3, FGFR 1-4, PDGFR-α/β, c-KIT, and RET, thereby potently suppressing angiogenesis. Accumulating evidence indicates that anlotinib plus chemotherapy is more effective than chemotherapy alone in advanced or recurrent ovarian cancer, with a manageable safety profile, showing encouraging efficacy and tolerability. Because conventional approaches for recurrent ovarian cancer are limited-particularly once platinum resistance develops-new therapeutic strategies are urgently needed. The best-characterized immune-checkpoint molecules are CTLA-4 and the PD-1/PD-L1 axis. Combined blockade of CTLA-4 and PD-1 has yielded impressive activity in several tumor types. Although single-agent checkpoint inhibitors produce modest response rates in recurrent ovarian cancer, preliminary data suggest that dual inhibition with anti-CTLA-4 plus anti-PD-1 antibodies may enhance therapeutic responses.QL1706 is a novel dual-target immunotherapeutic agent that has been approved for second-line monotherapy in cervical cancer.QL1706, developed by Qilu Pharmaceutical using the proprietary MabPair™ platform, is the first bispecific antibody simultaneously targeting PD-1 and CTLA-4, showing synergistic anti-tumor activity and favorable tolerability.The treatment of recurrent ovarian cancer remains a formidable challenge; therefore, proactive exploration of diverse combination regimens is essential to achieve optimal therapeutic efficacy and maximize survival benefit for patients.
Official title: A Single-arm, Multicenter Phase II Clinical Study of QL1706 Combined With Chemotherapy and Anlotinib for the Treatment of Recurrent Ovarian Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-11-15
Completion Date
2028-03-30
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
QL1706 plus chemotherapy and anlotinib regimen
QL1706 (5 mg/kg) IV d1, q3w Pegylated liposomal doxorubicin hydrochloride (30 mg/m²) IV d1, q3w Carboplatin (AUC = 5) IV d1, q3w -OR- cisplatin (75 mg/m²) IV d1, q3w Anlotinib: 8 mg PO qd d1-14, q3w Administer for 6 cycles.
Locations (1)
Lipai Chen
Guangzhou, Guangdong, China