Actively Recruiting
QL1706 Plus Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Phase II Trial
Led by Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Updated on 2025-12-16
50
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cervical cancer ranks as the second most common malignancy of the female genital tract. According to the World Health Organization, there are 530,000 new cases and approximately 250,000 cervical-cancer-related deaths worldwide each year, with 80% of these deaths occurring in women from developing countries. Early-stage disease can be managed surgically, whereas advanced or recurrent cervical cancer is treated with individualized multimodal therapy; nevertheless, the optimal management of locally advanced cervical cancer (FIGO 2018 stage IB3-IIA2) remains controversial. Chemoradiation is standard, but neoadjuvant chemotherapy followed by radical surgery after tumor down-staging is also used. More than 90% of cervical cancers are driven by persistent infection with high-risk human papillomavirus (HPV), which evades host immunity in part by up-regulating PD-L1 on tumor cells. Published series report PD-L1 positivity in 34.4-96% of cervical cancers, with even higher rates in squamous-cell histology, providing a rationale for PD-1/PD-L1 blockade. QL1706, a novel bispecific immunotherapeutic agent, has recently been approved as monotherapy for second-line treatment of advanced 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.Unlike previous phase II/III trials of PD-1 monotherapy, this study does not restrict enrolment to patients with PD-L1-positive tumors, so QL1706 is expected to confer benefit in the second-line management of recurrent or metastatic cervical cancer. Therefore, investigating QL1706-based combination regimens as neoadjuvant treatment for treatment-naïve disease is also highly relevant and may improve outcomes in women with locally advanced cervical cancer.
CONDITIONS
Official Title
QL1706 Plus Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 70 years at consent
- Histologically confirmed cervical cancer (squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma)
- No prior anti-cancer therapy for cervical cancer
- FIGO 2018 stage IB3, IIA2, or IIICr without lower third vaginal involvement or parametrial infiltration
- At least one measurable lesion by CT or MRI per RECIST 1.1
- Archival or fresh tumor tissue sample available for analysis
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function within 14 days before randomization
- Women of child-bearing potential must use highly effective contraception during the study and for 180 days after last dose
- Provided written informed consent
You will not qualify if you...
- Prior immunotherapy including PD-1, PD-L1, CTLA-4 inhibitors or cellular immunotherapy
- Severe infection requiring IV antibiotics for more than 7 days within 2 weeks before enrollment or unexplained fever over 38.5°C
- Systemic corticosteroids over 10 mg/day prednisone or other immunosuppressive drugs within 2 weeks before enrollment
- Immunomodulatory agents within 2 weeks before enrollment
- Use of high-dose aspirin, clopidogrel, or certain anticoagulants within 2 weeks before enrollment
- Use of specific Chinese herbal anti-cancer preparations within 2 weeks before enrollment
- Major surgery or significant injury within 4 weeks before enrollment
- Anti-cancer therapy within 4 weeks before enrollment
- Symptomatic CNS metastases or spinal-cord compression
- Clinically significant hydronephrosis not relieved by intervention
- Recurrent pleural effusion or ascites requiring repeated drainage
- Active or relapsing autoimmune disease except certain mild conditions
- Recent gastrointestinal or genitourinary perforation or intra-abdominal abscess
- Bowel obstruction or active intra-abdominal inflammation
- Serious cardiovascular disorders within 6 months before enrollment
- Conditions increasing risk of adverse events such as poorly controlled hypertension or bleeding disorders
- Interstitial lung disease or severe pulmonary impairment
- HIV-positive or active hepatitis B or C infection
- Active tuberculosis or syphilis
- Other active malignancies within 5 years except certain treated localized cancers
- Prior allogeneic stem-cell or organ transplant except corneal
- Live vaccine administration within 4 weeks before enrollment
- Participation in another clinical trial within 4 weeks before enrollment
- History of substance abuse or psychiatric/neurological disorders affecting compliance
- Known allergy to study drugs or components
- Any condition increasing study risk or interfering with results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lipai Chen
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
C
chen lipai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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