NCT05687851 Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer
| NCT ID | NCT05687851 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Chongqing University Cancer Hospital |
| Condition | Locally Advanced Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2022-12-29 |
| Primary Completion | 2024-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 33 participants in total. It began in 2022-12-29 with a primary completion date of 2024-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cadonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4. This is a single-arm, multicenter, open-label, phase II study, the purpose of this study is to evaluate the efficacy and safety of Cadonilimab plus radiotherapy in participants with locally advanced cervical cancer who do not tolerate chemotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Able to understand and voluntarily sign written informed consent. 2. Women aged ≥18 years at the time of study entry. 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2. 4. Life expectancy ≥12 weeks. 5. Intolerance to chemotherapy regimens. 6. Histologically confirmed cervical cancer. 1. Histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix; 2. Not receiving systemic anti-tumour therapy (including but not limited to radiotherapy, targeted therapy and immunotherapy, etc; concurrent chemotherapy is not included. Note: Removal or biopsy of pelvic lymph nodes or para-aortic lymph nodes for the purpose of clinical staging is allowed). 3. Locally advanced cervical cancer（LACC）: The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3/IIA2, IIB-IVA. 7. At least one measurable tumor lesion according to RECIST v1.1 criteria. 8. Available archived tumor tissue samples or recent biopsies. 9. Adequate organ function. 10. For fertile women with negative serum pregnancy and effective contraception within 7 days before administration (until 120 days after the last administration of the study drug and at least 180 days after radiotherapy) Exclusion Criteria: 1. Other histological types of cervical cancer (eg, neuroendocrine carcinoma, small cell carcinoma, sarcoma, etc). 2. Evidence of distant metastases. 3. Have received total hysterectomy. 4. Subject with other active malignancies within 2 years prior enter the study. 5. Subject who cannot receive brachytherapy. 6. Active or prior documented autoimmune disease that may relapse. 7. History of interstitial lung disease or noninfectious pneumonitis. 8. Subject with the clinically significant cardio-cerebrovascular disease. 9. History of severe hypersensitivity reactions to other mAbs. 10. Prior allogeneic stem cell transplantation or organ transplantation. 11. Subjects who require systemic treatment with glucocorticoid (\>10 mg/day of prednisone or equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior enter the study. 12. Receipt of live attenuated vaccines within 30 days prior to the first dose of the study drug. 13. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc). 14. Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the study drug or interpretation of subject safety or study results.
Contact & Investigator
Qi Zhou, MD
PRINCIPAL INVESTIGATOR
Chongqing University Cancer Hospital
Frequently Asked Questions
Who can join the NCT05687851 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Locally Advanced Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05687851 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05687851 currently recruiting?
Yes, NCT05687851 is actively recruiting participants. Contact the research team at longxingtao2009@163.com for enrollment information.
Where is the NCT05687851 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT05687851 clinical trial?
NCT05687851 is sponsored by Chongqing University Cancer Hospital. The principal investigator is Qi Zhou, MD at Chongqing University Cancer Hospital. The trial plans to enroll 33 participants.
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