RecruitingPhase 2NCT07286240

QL1706 Combined With Chemotherapy and Anlotinib for the Treatment of Recurrent Ovarian Cancer

A Single-arm, Multicenter Phase II Clinical Study of QL1706 Combined With Chemotherapy and Anlotinib for the Treatment of Recurrent Ovarian Cancer


Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Enrollment

40 participants

Start Date

Nov 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three drugs — QL1706 (an immunotherapy), chemotherapy, and anlotinib (a targeted anti-cancer drug) — for women with ovarian cancer that has come back after standard platinum-based treatment. **You may be eligible if...** - You are a woman aged 18–70 with confirmed ovarian, fallopian tube, or peritoneal cancer - Your cancer has come back after platinum-based chemotherapy (either more than 6 months later, or sooner — both groups are eligible) - Your performance level is good (ECOG 0–1) - You have at least 3 months life expectancy **You may NOT be eligible if...** - You have not previously received platinum-based chemotherapy - Your cancer has not been confirmed by a tissue biopsy - You have serious organ problems that would prevent treatment - You have not recovered from side effects of prior treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQL1706 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

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NCT07286240