QL1706 Plus Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer: A Phase II Trial

NCT07286253 | Recruiting Phase 2

• 1 other identifier: QL-CC-QIBA-3005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neoadjuvant Treatment for Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR)

  Pathological complete response (pCR) is defined as the absence of residual malignant tumor cells in the resected specimen.

  2 years

Secondary Outcomes (3)

• Objective response rate (ORR)

  2 years

• Disease-free survival (DFS)

  2 years

• 2-year disease-free survival rate (2-year DFS rate)

  2 years

Study Arms (1)

Experimental: QL1706 plus nab-paclitaxel plus cisplatin/carboplatin

EXPERIMENTAL

Drug: Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W

Interventions

Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W DRUG

Drug: Drug: QL1706 5mg/kg, iv drip,d1,Q3W;Albumin-Bound Paclitaxel 260mg/m2, iv drip, d1, Q3W;Cisplatin50mg/m2, iv drip, d1, Q3W;Carboplatin AUC 5 ivdrip, d1, Q3W

Experimental: QL1706 plus nab-paclitaxel plus cisplatin/carboplatin

Eligibility Criteria

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

You may qualify if:

• (1) Has given written informed consent (or consent provided by an immediate family member if the subject is unable to do so) after full explanation of the study.
• (2) Female, aged ≥ 18 and ≤ 70 years on the date of informed-consent signature. (3) Histologically confirmed cervical cancer: A. Squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; B. Previously untreated-no prior anti-cancer therapy for cervical cancer; C. FIGO 2018 stage IB3 or IIA2; D. Stage IIICr without involvement of the lower third of the vagina and without parametrial infiltration.
• (4) At least one measurable lesion by CT or MRI per RECIST 1.1. Note: Lesions situated in a prior radiation field or previously treated by local-regional therapy must be classified as non-target lesions unless clear progression is documented or tumor viability is confirmed by biopsy, and no other measurable lesion exists; in that case the lesion may serve as a target lesion.
• (5) Archival tumor tissue obtained within 5 years before enrollment OR a freshly obtained biopsy (≈ 7 unstained FFPE slides, minimum 5; preference for recent sample).
• The biopsied lesion must not be selected as a RECIST 1.1 target lesion unless no other site is suitable and the biopsy was performed outside the screening period. If a subject cannot provide the required slides and the investigator judges re-biopsy to be unsafe, the number of slides may be reduced at the investigator's discretion.
• (6) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. (7) Life expectancy ≥ 12 weeks. (8) Adequate function of major organs documented within 14 days before randomisation (no transfusion, albumin, recombinant human thrombopoietin or colony-stimulating factors allowed during this period): Haematology Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelets ≥100 × 10⁹/L Haemoglobin ≥90 g/L Hepatic Total bilirubin ≤1.5 × upper limit of normal (ULN) ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present) Serum albumin ≥30 g/L Renal Serum creatinine ≤1.5 × ULN; OR if \>1.5 × ULN, calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault) Coagulation APTT ≤1.5 × ULN PT/INR ≤1.5 × ULN Cardiac Left-ventricular ejection fraction (LVEF) ≥50% Urinalysis Dipstick proteinuria \<2+ If ≥2+, 24-hour urine protein must be \<1.0 g to permit entry (9) Women of child-bearing potential must use a highly effective contraceptive method from informed-consent signature until 180 days after the last study-dose administration and must not be pregnant or lactating.

You may not qualify if:

• (1) Prior exposure to any immunotherapy, including immune-checkpoint inhibitory antibodies (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4), immune-checkpoint agonistic antibodies (e.g., anti-ICOS, CD40, CD137, GITR, OX40), or cellular immunotherapy.
• (2) Systemic or severe infection requiring intravenous antibiotics for \>7 days within 2 weeks before enrolment, or unexplained fever \>38.5 °C detected during screening or within 2 weeks prior to enrolment (fever judged by the investigator to be tumour-related is permitted).
• (3) Systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive agents (e.g., cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors) for any indication within 2 weeks before enrolment. Topical, nasal or inhaled corticosteroids are allowed; systemic steroids given solely for prophylaxis of contrast allergy are also permitted.
• (4) Treatment with immunomodulatory agents such as thymosin, lentinan, interferon or interleukins within 2 weeks before enrolment.
• (5) Use within 2 weeks before enrolment of aspirin (\>325 mg/day), clopidogrel (\>75 mg/day), dipyridamole, ticlopidine, cilostazol, or any therapeutic-dose anticoagulant other than low-molecular-weight heparin.
• (6) Use of modern Chinese herbal preparations approved by NMPA for anti-cancer therapy within 2 weeks before enrolment.
• (7) Major surgery, open biopsy or significant traumatic injury within 4 weeks before enrolment; or planned elective major surgery during the study. Local invasive procedures (e.g., core biopsy) within 1 week before enrolment are excluded, except for vascular-access device placement.
• (8) Anti-cancer therapy (chemotherapy, endocrine therapy, targeted therapy, biological therapy, trans-arterial chemo-embolisation, etc.) within 4 weeks before enrolment.
• (9) Symptomatic CNS metastases, leptomeningeal disease or spinal-cord compression at baseline. Asymptomatic subjects with stable CNS disease who have completed any prior CNS-directed therapy ≥2 weeks earlier and have been off corticosteroids and anti-convulsants for ≥2 weeks may be enrolled.
• (10) Clinically significant hydronephrosis that cannot be relieved by nephrostomy or ureteral stenting.
• (11) Recurrent third-space fluid (e.g., pleural effusion or ascites) requiring repeated drainage and judged poorly controlled.
• (12) Active or potentially relapsing autoimmune disease, except: vitiligo, alopecia, psoriasis or eczema not requiring systemic therapy; hypothyroidism due to autoimmune thyroiditis on stable hormone replacement; or type 1 diabetes on stable-dose insulin.
• (13) History of gastrointestinal or genitourinary perforation/fistula, or intra-abdominal abscess within 6 months before enrolment (subjects are eligible if the underlying defect has been surgically corrected).
• (14) Bowel obstruction within 6 months before enrolment (subjects with incomplete obstruction that has resolved after treatment may be enrolled at the investigator's discretion), active intra-abdominal inflammation (including but not limited to peptic ulcer, diverticulitis or colitis).
• (15) Clinically significant cardiovascular disorders:

Sponsors & Collaborators

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

Study Sites (1)

Lipai Chen

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

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: SINGLE GROUP
• 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: October 28, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)