Combining Cadonilimab with Radiotherapy for Advanced Cervical Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the safety and efficacy of Cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, in conjunction with radiotherapy for women with locally advanced cervical cancer who cannot tolerate chemotherapy. The study is single-arm and multicenter, focusing on patients with specific histologically confirmed types of cervical cancer. Participants will receive Cadonilimab along with external beam radiotherapy and brachytherapy, with the aim of assessing treatment outcomes and safety profiles.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chongqing university Cancer Hospital
  Chongqing, Chn, China Recruiting

Study contacts

• Principal investigator: Qi Zhou, MD — Chongqing University Cancer Hospital
• Study coordinator: Xingtao Long, MD
• Email: longxingtao2009@163.com
• Phone: +8602365075619

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cadonilimab plus cisplatin given before surgery for locally advanced cervical cancer

  This study will test whether giving cadonilimab together with cisplatin before surgery helps people with resectable, locally advanced cervical cancer.

  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07104149

• Cadonilimab and Lenvatinib in advanced kidney cancer

  This study tests whether Cadonilimab plus Lenvatinib can help adults with unresectable, advanced renal cell carcinoma, especially clear cell type, after prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Panjiayuan Nanli · NCT07909265

• Iparomlimab/Tuvonralimab with nab-paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer

  This trial tests whether adding Iparomlimab/Tuvonralimab to nab-paclitaxel and cisplatin before surgery can shrink locally advanced cervical cancer and safely be given to adult women.

  Recruiting Phase 2 Xijing Hospital · Xi'an, Shaanxi · NCT07876154

• FAPI-guided radiotherapy with cadonilimab plus chemo for colorectal cancer limited to the peritoneum

  Aims to see if adding targeted radiotherapy and cadonilimab immunotherapy to standard second-line chemotherapy helps adults with colorectal cancer that’s spread only to the peritoneum.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07815834

• Vitamin D Status and Outcomes in Locally Advanced Cervical Cancer treated with chemoradiotherapy

  This study tests whether pretreatment vitamin D levels can predict how well women with locally advanced cervical cancer respond to standard chemoradiotherapy.

  Recruiting University of Kragujevac · Kragujevac, Šumadija · NCT07743918

• Cadonilimab with chemotherapy vs chemotherapy with/without nivolumab as first-line treatment for HER2-negative advanced gastric/GEJ cancer

  This study tests whether adding cadonilimab to chemotherapy helps people with newly diagnosed, unresectable or metastatic HER2-negative gastric/GEJ cancer live longer, compared with standard chemo alone (with or without nivolumab).

  Recruiting Phase 3 Akeso · Phoenix, Arizona and 24 other locations · NCT07700979

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.