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

QL1706 Combined With Chemotherapy and Anlotinib for the Treatment of Recurrent Ovarian Cancer (NCT07286240) is a Phase 2 interventional studying Treatment of Recurrent Ovarian Cancer, sponsored by Affiliated Cancer Hospital & Institute of Guangzhou Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Treatment of Recurrent Ovarian Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 40 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 1.Capable of understanding and voluntarily signing the written willing to sign a consent form Form (ICF); the ICF must be signed before any study-specific procedures are performed. 2.Female, aged 18-70 years at the time of ICF signature. 3.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4.Life expectancy ≥ 3 months. 5.diagnosed by tissue sample (biopsy-confirmed) epithelial ovarian cancer (including fallopian-tube and primary peritoneal carcinoma) that has recurred after standard platinum-based therapy: 1. Platinum-sensitive relapse (recurrence ≥ 6 months after completion of the last platinum-based therapy). 2. Platinum-resistant relapse (recurrence \< 6 months after completion of the last platinum-based therapy or progression while on PARP-inhibitor maintenance). Note: Maintenance PARP inhibitor or bevacizumab after CR/PR to prior chemotherapy, and hormonal therapy, are not counted as additional lines of therapy. 6.At least one measurable lesion per RECIST v1.1. Lesions previously irradiated or treated with other loco-regional therapy can serve only as non-target lesions unless clear progression is documented or tumor viability is biopsy-proven. 7.Archived or freshly obtained tumor tissue (primary or relapse) must be available for biomarker analyses. Five unstained formalin-fixed paraffin-embedded (FFPE) slides or a tissue block are required for central PD-L1 testing (slides preferred). If re-biopsy is judged unsafe, the number of slides may be reduced after discussion with the medical monitor. 8.your organs (liver, kidneys, etc.) are working well enough based on blood tests at screening: Hematology: Hb ≥ 90 g/L white blood cell count (ANC) at least 1.5 × 10⁹/L PLT ≥ 100 × 10⁹/L Biochemistry: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 1.Capable of understanding and voluntarily signing the written Informed Consent Form (ICF); the ICF must be signed before any study-specific procedures are performed. 2.Female, aged 18-70 years at the time of ICF signature. 3.Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 4.Life expectancy ≥ 3 months. 5.Histologically confirmed epithelial ovarian cancer (including fallopian-tube and primary peritoneal carcinoma) that has recurred after standard platinum-based therapy: 1. Platinum-sensitive relapse (recurrence ≥ 6 months after completion of the last platinum-based therapy). 2. Platinum-resistant relapse (recurrence \< 6 months after completion of the last platinum-based therapy or progression while on PARP-inhibitor maintenance). Note: Maintenance PARP inhibitor or bevacizumab after CR/PR to prior chemotherapy, and hormonal therapy, are not counted as additional lines of therapy. 6.At least one measurable lesion per RECIST v1.1. Lesions previously irradiated or treated with other loco-regional therapy can serve only as non-target lesions unless clear progression is documented or tumor viability is biopsy-proven. 7.Archived or freshly obtained tumor tissue (primary or relapse) must be available for biomarker analyses. Five unstained formalin-fixed paraffin-embedded (FFPE) slides or a tissue block are required for central PD-L1 testing (slides preferred). If re-biopsy is judged unsafe, the number of slides may be reduced after discussion with the medical monitor. 8.Adequate organ function at screening: Hematology: Hb ≥ 90 g/L ANC ≥ 1.5 × 10⁹/L PLT ≥ 100 × 10⁹/L Biochemistry: Albumin ≥ 29 g/L ALT/AST \< 3 × ULN (\< 5 × ULN if liver metastases) TBIL ≤ 1.5 × ULN Creatinine ≤ 1.5 × ULN 9.Women of child-bearing potential must have a negative serum pregnancy test within 3 days before first dose. If sexually active with a non-sterilized male partner, they must use a highly effective contraceptive method from screening until 6 months after the last study-dose; rhythm or withdrawal methods are not acceptable. 10.The need for additional cytoreductive surgery is at the investigator's discretion. Exclusion Criteria: * 1.Non-epithelial ovarian malignancies (e.g., carcinosarcoma, sex-cord stromal tumors). 2.Central-nervous-system metastases or meningeal carcinomatosis. 3.Pleural, pericardial, or ascitic effusions requiring repeat drainage \> once per month. 4.Active malignancy within 3 years before first dose, except locally curable cancers deemed cured (e.g., squamous- or basal-cell skin cancer, superficial bladder cancer, ductal carcinoma in situ of breast). 5.Prior systemic anti-cancer therapy within 3 weeks (chemotherapy, bevacizumab/biosimilars, TKI, PARP inhibitor); palliative radiotherapy or immunomodulators (e.g., thymosin, interferon, IL-2) or cancer-treating Chinese patent medicines (e.g., Aidi injection) within 2 weeks; hormonal agents (e.g., tamoxifen, letrozole) within 1 week. 6.Previous immune-checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.) or agonists of immune co-stimulatory molecules (ICOS, CD40, CD137, GITR, OX40, etc.). 7.Major surgery, open biopsy, or significant trauma within 4 weeks; elective major surgery planned during study. 8.Active or likely recurrent autoimmune disease (exceptions: vitiligo, alopecia, psoriasis/eczema not requiring systemic therapy; hypothyroidism from autoimmune thyroiditis on stable replacement; type 1 diabetes on stable insulin). 9.Systemic corticosteroids \> 10 mg/day prednisone equivalent or other immunosuppressants within 14 days (inhaled, ophthalmic, or topical steroids ≤ 10 mg/day permitted). 10.Live vaccine within 4 weeks. 11.Primary or secondary immunodeficiency, including positive HIV antibody. 12.Prior solid-organ or allogeneic hematopoietic-stem-cell transplant. 13.History of interstitial lung disease or non-infectious pneumonitis. 14.Severe infection within 4 weeks (complicated infection requiring hospitalization, sepsis, severe pneumonia). 15.Active infection requiring systemic therapy (including active TB or active syphilis) or systemic antibiotics/antivirals/antifungals within 2 weeks (except suppressive anti-HBV therapy). 16.Active hepatitis B (HBsAg-positive with HBV DNA \> 1000 IU/mL); active hepatitis C. Inactive HBV carriers with HBV DNA ≤ 1000 IU/mL are eligible. Subjects with cured HCV (HCV Ab-positive and HCV RNA-negative) are eligible. 17.Inflammatory bowel disease (Crohn's, ulcerative colitis), active diverticulitis, clinical bowel obstruction, or need for parenteral hydration/nutrition or nasogastric tube. 18.Significant cardiovascular/cerebrovascular disease: 1. MI, unstable angina, pulmonary embolism, aortic dissection, DVT, arterial thrombo-embolism within 6 months 2. NYHA class ≥ II heart failure 3. Serious arrhythmia requiring chronic therapy (stable-rate asymptomatic atrial fibrillation allowed) 4. CVA within 6 months 5. LVEF \< 50 % 6. Prior myocarditis/cardiomyopathy; uncontrolled hypertension (\> 150/100 mmHg) or hypertensive crisis/encephalopathy 19.Peripheral neuropathy ≥ grade 2 (NCI CTCAE v5.0). 20.Unresolved toxicity \> grade 1 from prior anti-cancer therapy (except alopecia). 21.Severe hypersensitivity to any monoclonal antibody. 22.Pregnancy or lactation. 23.Any condition that, in the investigator's opinion, would compromise safety, interfere with study evaluations, or confound results (e.g., severe concomitant disease or psychiatric disorder). 24.Known hypersensitivity to any study drug or excipient. 25.Prior gastrointestinal perforation, intra-abdominal abscess, or bowel obstruction within 3 months or radiologic/clinical evidence of obstruction. 26.Hypertension inadequately controlled on medication (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg). 27.Coagulopathy (INR \> 2.0 or PT \> 16 s), bleeding diathesis, or thrombolytic/anticoagulant therapy (prophylactic low-dose aspirin or LMWH allowed). 28.Clinically significant bleeding or bleeding tendency within 3 months (e.g., GI bleeding, hemorrhagic gastritis, vasculitis). 29.Arterial or venous thrombosis within 6 months (CVA, TIA, intracranial bleed, DVT, PE); superficial vein thrombosis may be allowed at investigator's discretion. 30.Hereditary or acquired bleeding/thrombotic disorders (e.g., hemophilia, coagulation defects, thrombocytopenia). 31.Active ulcer, non-healing wound, or fracture. 32.Urine protein ≥ ++ confirmed by 24-h urine protein \> 1.0 g. 33.Prior palliative radiotherapy to \> 5 % of bone-marrow area within 4 weeks. 34.Strong CYP3A4 inducers within 2 weeks or strong CYP3A4 inhibitors within 1 week. 35.Prior treatment with anlotinib or other small-molecule multi-target TKIs.

Treatments Being Tested

DRUG

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Lipai Chen

Guangzhou, Guangdong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07286240), the sponsor (Affiliated Cancer Hospital & Institute of Guangzhou Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07286240 clinical trial studying?

Who can participate in NCT07286240?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07286240?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07286240. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07286240. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.