A Clinical Study of QL1706 Combined With Chemotherapy as Neoadjuvant Therapy for High-Risk Locally Advanced Cervical Cancer

NCT07613567 | Not Yet Recruiting Phase 3

• 1 other identifier: QL-CC-QIBA-3078
• Study Type: interventional
• Target: 486
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety of "neoadjuvant immunotherapy combined with chemotherapy followed by immunotherapy combined with radiotherapy during the radiotherapy period" versus "standard concurrent chemoradiotherapy" in locally advanced cervical cancer.

Conditions

Locally Advanced Cervical Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival（PFS）

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

  Up to approximately 60 months

Secondary Outcomes (10)

• Overall Survival (OS)

  Up to approximately 60 months

• Objective Response Rate (ORR)

  Up to approximately 60 months

• Disease Control Rate (DCR)

  Up to approximately 3 years

• Clinical Complete Response Rate, CCR

  Up to approximately 6 months

• Duration of Response (DOR)

  Up to approximately 3 years

Study Arms (2)

Standard concurrent chemoradiotherapy（CCRT）

ACTIVE COMPARATOR

Accept standard concurrent chemoradiotherapy

Radiation: standard EBRT+Brachytherapy; Drug: Cisplatin

Neoadjuvant Therapy Group

EXPERIMENTAL

Participants in the experimental arm will receive 2 cycles of QL1706 + paclitaxel (albumin-bound) + Cisplatin/Carboplatin. Following neoadjuvant therapy, patients will undergo EBRT + QL1706. After EBRT completion, patients with clinical complete response (CCR) will receive brachytherapy at a dose of 600 cGy × 3 fractions; patients without CCR will receive brachytherapy at a dose of 600 cGy × 5 fractions. Subsequent sequential QL1706 will be administered for up to 2 years, until disease progression, or unacceptable toxicity.

Drug: Neoadjuvant chemoimmunotherapy; Radiation: Radiotherapy combined with immunotherapy; Drug: Immunomaintenance therapy

Interventions

standard EBRT+Brachytherapy RADIATION

EBRT: 45-50.4Gy, Brachytherapy: 6Gy ×5

Standard concurrent chemoradiotherapy（CCRT）

Cisplatin DRUG

Cisplatin 40mg/m2, qw×5

Standard concurrent chemoradiotherapy（CCRT）

Neoadjuvant chemoimmunotherapy DRUG

Neoadjuvant phase: total of 2 cycles. Iparomlimab/Tuvonralimab 5mg/kg,D1,Q3W + albumin paclitaxel 90mg/m2, D1、8、15，Q3W+ Cisplatin 25mg/m2 or Carboplatin AUC = 1.5 , D1、8、15，Q3W

Neoadjuvant Therapy Group

Immunomaintenance therapy DRUG

Iparomlimab/Tuvonralimab (QL1706) 5 mg/kg，D1,Q3W. Will be administered for up to 2 years, until disease progression, or until unacceptable toxicity, whichever occurs first.

Neoadjuvant Therapy Group

Radiotherapy combined with immunotherapy RADIATION

Following neoadjuvant therapy, patients will receive EBRT + QL1706. After EBRT completion, brachytherapy dose is 600 cGy × 3 fractions for patients with clinical complete response (CCR), and 600 cGy × 5 fractions for non-CCR patients.

Neoadjuvant Therapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age: 18-75 years; 2) Histologically confirmed cervical squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma; 3) Locally advanced disease (Stage III-IVA per FIGO 2018 staging criteria, including IIIC1/IIIC2), confirmed by imaging evaluation; 4) ECOG performance status 0-1; 5) Expected to be able to complete external beam radiation therapy (EBRT) combined with brachytherapy; 6) No definite contraindications to radiotherapy; 7) Able to provide pathological specimens (≥18 qualified tissue slides) for biomarker testing; 8) No prior surgery, radiotherapy, chemotherapy, systemic therapy (including investigational drugs), or immunotherapy for cervical cancer; 9) At least one measurable lesion (per RECIST 1.1: ≥10 mm longest diameter for non-lymph node lesions on CT; ≥15 mm short axis for lymph node lesions on CT); 10) Expected survival ≥6 months; 11) Adequate major organ function. Hematology (without transfusion or blood products within 14 days): ANC ≥1.5×10⁹/L; platelets ≥80×10⁹/L; hemoglobin ≥9 g/dL. Biochemistry: total bilirubin \<1.5×ULN; AST and ALT ≤2.5×ULN; serum creatinine ≤1.5×ULN, or creatinine clearance ≥40 mL/min (using the standard Cockcroft-Gault formula); 12) Participants have signed informed consent and agree to comply with follow-up; 13) Women of childbearing potential must agree to use effective contraception during the study and for at least 12 months after the last dose (postmenopausal women or women not of childbearing potential are exempt).

You may not qualify if:

• \) Diagnosed with other malignancies within 5 years prior to first dose, excluding radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, radically excised carcinoma in situ, and/or papillary thyroid carcinoma; 2) Histologically confirmed small cell (neuroendocrine) cervical carcinoma, cervical carcinosarcoma, or gastric-type cervical adenocarcinoma; 3) FIGO 2018 Stage IVB disease; 4) Prior total hysterectomy (defined as removal of the entire uterus) or planned hysterectomy as part of initial cervical cancer treatment; 5) Bilateral hydronephrosis, unless at least one side has been stented or resolved by nephrostomy, or considered mild and not clinically significant by the investigator; 6) Anatomical or tumor geometric contraindications to intracavitary brachytherapy or combined intracavitary and interstitial brachytherapy, or any other contraindications; 7) Live vaccine administration within 30 days prior to first dose of study treatment; 8) Systemic immunostimulatory agents, colony-stimulating factors, interferons, interleukins, or vaccine combinations within 6 weeks or 5 half-lives (whichever is shorter) prior to Day 1 of Cycle 1; 9) Prior treatment with anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agents, or agents targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137); 10) Systemic anti-cancer therapy within 4 weeks prior to randomization, including investigational drugs; 11) Currently participating in or previously participated in a study with an investigational drug; 12) Contraindications to cisplatin use; 13) Diagnosed with immunodeficiency or receiving chronic systemic corticosteroid therapy (\>10 mg/day prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to first study treatment; 14) Hypersensitivity to any study drug; 15) Active autoimmune disease requiring systemic therapy within the past 2 years; 16) History of (non-infectious) pneumonitis/interstitial lung disease requiring corticosteroids, or current pneumonitis/interstitial lung disease; 17) Active infection requiring systemic treatment; 18) Known history of human immunodeficiency virus (HIV) infection; 19) Known history of hepatitis B or known active hepatitis C viral infection; 20) Any condition, treatment, laboratory abnormality, or other circumstance that may increase risk associated with study participation or administration of study treatment, or may interfere with interpretation of study results, and judged by the investigator or sponsor to render the participant unsuitable for this study; 21) Known psychiatric or substance abuse disorders that would interfere with the participant's ability to comply with study requirements; 22) Prior allogeneic tissue/solid organ transplantation; 23) Evidence of metastatic disease per RECIST 1.1, including lymph nodes in the inguinal region or above the level of the L1 vertebral body; 24) Women with pregnancy desire, pregnant women, or breastfeeding women.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Interventions

Cisplatin; Immunotherapy

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Immunomodulation; Biological Therapy; Therapeutics

Central Study Contacts

Qin Xu

CONTACT

13950419396; xuqin@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, multicenter, phase III clinical study. Enrolled participants will be randomly assigned in a 1:1 ratio to the neoadjuvant therapy group and the standard concurrent chemoradiotherapy group.

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2032
• Study Completion (Estimated): August 31, 2032
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)