NCT05817214

Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer

Recruiting now Phase 2 Last updated 19 April 2024

What this trial tests

Phase 2 trial testing Cadonilimab in Cervical Cancer in 35 participants. Currently enrolling.

Timeline

16 February 2023

Primary endpoint
30 November 2025

28 February 2027

Quick facts

Lead sponsor	Zhongnan Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	16 February 2023
Primary completion	30 November 2025
Estimated completion	28 February 2027
Sites	1 location across China

Drugs / interventions tested

• Cadonilimab — full drug profile →
• Anlotinib — full drug profile →
• Granulocyte-Macrophage Colony-Stimulating Factor

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

Zhongnan Hospital

Who can join

Adults 18 to 75, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to test a new treatment combination including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent, metastasis and persistent cervical cancer. The main questions it aims to answer are:

* The efficacy of this combination in R/M/P CC;
* The tolerance of this combination in R/M/P CC;
* Possible biomarker of treatment response for this combination.

Participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break and subcutaneously injection of GM-CSF (200ug) from day 1 to day 14, then also take a 7-days break. This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in cervical cancer: current insights and future directions.
   Xu M, Cao C, Wu P, Huang X, et al · · 2025 · cited 55× · PMID 39611440 · DOI 10.1002/cac2.12629
2. The promise of PD1/PDL1 targeted immunotherapy in locally advanced cervical cancer: a game-changer for patients outcome?
   Kouhen F, El Ghanmi A, Inghaoun H, Miftah H, et al · · 2025 · cited 3× · PMID 40433369 · DOI 10.3389/fimmu.2025.1573576
3. Efficacy and safety of immune checkpoint inhibitors combined with antiangiogenic agents in advanced cervical cancer: a systematic review and meta-analysis.
   Zhang D, Meng Y, Dong X, Huang C, et al · · 2026 · PMID 42253994 · DOI 10.3389/fimmu.2026.1747768
4. Advancements in the utilization of immune checkpoint inhibitors for the treatment of gynecological tumors.
   Su Z, Zhang X, Xu J, Shen Y. · · 2026 · PMID 41983132 · DOI 10.3389/fimmu.2026.1686568
5. Bispecific antibodies in the treatment of epithelial ovarian, endometrial, and cervical cancer: an overview of current applications, challenges, and emerging opportunities.
   Parola S, Colombo I. · · 2025 · PMID 41211166 · DOI 10.37349/etat.2025.1002345