Clinical trial · Interventional
QL1706 Plus Chemotherapy±Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate QL1706 Plus Paclitaxel-Cisplatin/Carboplatin With or Without Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| METASTATIC CERVICAL CANCER | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin/Carboplatin | Drug | — | UNRESOLVED |
| Paclitaxel injection | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| QL1706 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QL1706+chemotherapy± bevacizumab
- description
- QL1706 (5 mg/kg) + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
- interventionNames
- Drug: QL1706
- Drug: Paclitaxel injection
- Drug: Cisplatin/Carboplatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo+chemotherapy± bevacizumab
- description
- Placebo + paclitaxel (175 mg/m2) + cisplatin (50 mg/m2)/carboplatin (AUC 5) ± bevacizumab (15 mg/kg)
- interventionNames
- Drug: Placebo
- Drug: Paclitaxel injection
- Drug: Cisplatin/Carboplatin
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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: * 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
References
Publications (1)
- DERIVEDZhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1. PMID 37158938