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RecruitingNCT05446883Updated Nov 30, 2022

QL1706 Plus Chemotherapy±Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

A Phase 3 interventional study of QL1706 and Placebo in METASTATIC CERVICAL CANCER, sponsored by Qilu Pharmaceutical Co., Ltd.. Recruiting at 3 sites in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-30.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years later.
Phase
Phase 3
Study type
Interventional
Enrollment
498
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study in 498 patients with persistent, recurrent or metastatic cervical cancer.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab; Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab

Read the detailed description

Subjects must provide sufficient archival or newly obtained tumor tissue samples to determine PD-L1 expression level to be eligible for screening.During the screening phase, eligible subjects will be stratified by use of bevacizumab (yes vs no), prior concurrent chemoradiation therapy (yes vs no), and PD- L1 level (CPS \< 1 vs 1 ≤ CPS \< 10 vs CPS ≥ 10) and randomized 1:1 into the experimental or control arm.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab;Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab

02

Conditions studied

  • METASTATIC CERVICAL CANCER
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 498 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • The subject fully understood and voluntarily signed the informed consent form.
  • Histologically confirmed cervical cancer.
  • At least one measurable tumor lesion by CT or MRI according to RECIST 1.1 criteria.
  • All subjects must provide archived or freshly obtained tumor tissue samples, approximately 7 (minimum of 5) unstained FFPE pathology slides (preferably newly obtained tumor tissue samples) within 5 years prior to randomization.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Expected survival ≥ 12 weeks.
  • Adequate level of vital organ function

Exclusion criteria

Exclusion Criteria:

  • Previously received immunotherapy, including immune checkpoint inhibitory antibodies (such as: anti-PD-1, PD-L1, CTLA-4 antibodies, etc.), immune checkpoint agonistic antibodies (such as: anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapy; previously received VEGF/VEGFR inhibitors, such as bevacizumab, ramucirumab, abercept and tyrosine kinase inhibitors.
  • Systemic infection or other serious infection requiring intravenous antibiotics for 7 days before randomization, or unexplained fever > 38.5℃ during screening or before enrollment (except fever caused by tumor, as judged by the investigator)
  • Within two weeks before randomization, there is a need for systemic use of corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) treatment of the disease; Topical corticosteroids, nasal sprays, and inhaled steroids are allowed. Systemic corticosteroids are permitted for the prevention of contrast allergy。
  • Systemic treatment with immunomodulatory drugs (such as thymosin, lentinan, interferon, interleukin, etc.) within two weeks before randomization
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
498 participants (estimated)

Study arms

  • Experimental
    QL1706+chemotherapy± bevacizumab

    QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)

    Drug: QL1706 · Drug: Paclitaxel injection · Drug: Cisplatin/Carboplatin

  • Placebo comparator
    Placebo+chemotherapy± bevacizumab

    Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)

    Drug: Placebo · Drug: Paclitaxel injection · Drug: Cisplatin/Carboplatin

Interventions

  • DrugQL1706

    Intravenous Infusion

  • DrugPlacebo

    Intravenous Infusion

  • DrugPaclitaxel injection

    Intravenous Infusion

  • DrugCisplatin/Carboplatin

    Intravenous Infusion

06

What researchers measure

Primary outcomes

  1. PFS by BICR based on RECIST v1.1

    PFS by BICR based on RECIST v1.1

    Time frame: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)

  2. OS

    OS

    Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 2 years

Secondary outcomes

  1. PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria

    PFS and 12-month PFS rate assessed by investigator based on RECIST v1.1 criteria

    Time frame: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months

07

Study locations

3 of 3 sites recruiting
  • Chongqing University Cancer Hospital
    Chongqing, Chongqing 400000, China
    • Qi Zhou · Contact
    • Dongling Zou · Contact
    Recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
  • Liaoning Cancer Hospital
    Shenyang, Liaoning 110000, China
    • Danbo Wang · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Involves subject privacy and does not intend to share

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05446883
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 7, 2022
Start date
Sep 23, 2022
Primary completion
Sep 1, 2024 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Nov 30, 2022

Study contacts

Xiaoli Zhang
Contact
xiaoli3.zhang@qilu-pharma.com
008610-50813552

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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