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

NCT07286240 | Recruiting Phase 2

• 1 other identifier: QL-0ca-QIBA-3003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment of Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  The ratio of patients who are evaluated as CR or PR

  2 years

• PFS

  PFS: defined as the time from the date of first dose to the first documented progressive disease (PD) or death from any cause, whichever occurs first, within the tumor-assessment follow-up period.

  2 years

Secondary Outcomes (5)

• DCR

  2 years

• OS

  2 years

• DOR

  2 years

• TTR

  2 years

• CA125 response

  2 years

Study Arms (1)

QL1706 plus chemotherapy and anlotinib regimen

EXPERIMENTAL

Drug: QL1706 plus chemotherapy and anlotinib regimen

Interventions

QL1706 plus chemotherapy and anlotinib regimen DRUG

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.

QL1706 plus chemotherapy and anlotinib regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of understanding and voluntarily signing the written Informed Consent Form (ICF); the ICF must be signed before any study-specific procedures are performed.
• 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:
• Platinum-sensitive relapse (recurrence ≥ 6 months after completion of the last platinum-based therapy).
• 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.
• 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.
• 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.
• 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.
• The need for additional cytoreductive surgery is at the investigator's discretion.

You may not qualify if:

• Non-epithelial ovarian malignancies (e.g., carcinosarcoma, sex-cord stromal tumors).
• Central-nervous-system metastases or meningeal carcinomatosis. 3.Pleural, pericardial, or ascitic effusions requiring repeat drainage \> once per month.
• 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).
• 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.
• 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.).
• Major surgery, open biopsy, or significant trauma within 4 weeks; elective major surgery planned during study.
• 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).
• Systemic corticosteroids \> 10 mg/day prednisone equivalent or other immunosuppressants within 14 days (inhaled, ophthalmic, or topical steroids ≤ 10 mg/day permitted).
• 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).
• Active infection requiring systemic therapy (including active TB or active syphilis) or systemic antibiotics/antivirals/antifungals within 2 weeks (except suppressive anti-HBV therapy).
• 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.
• Inflammatory bowel disease (Crohn's, ulcerative colitis), active diverticulitis, clinical bowel obstruction, or need for parenteral hydration/nutrition or nasogastric tube.
• Significant cardiovascular/cerebrovascular disease:
• MI, unstable angina, pulmonary embolism, aortic dissection, DVT, arterial thrombo-embolism within 6 months
• NYHA class ≥ II heart failure

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Study Sites (1)

Lipai Chen

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

chen lipai

CONTACT

13556170919; chenlipai@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-09

Locations

CN (1)