RecruitingPhase 2NCT05817214

Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer

Cadonilimab Plus Anlotinib for Recurrent, Metastasis or Persistent Cervical Cancer


Sponsor

Zhongnan Hospital

Enrollment

35 participants

Start Date

Feb 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining two drugs — cadonilimab (an immunotherapy) and anlotinib (a drug that blocks tumor blood vessel growth) — is safe and effective for women with recurrent, metastatic, or persistent cervical cancer. This type of cancer has come back or spread after initial treatment, which makes it difficult to manage. **You may be eligible if...** - You are a woman aged 18–75 - You have cervical cancer (squamous cell, adenocarcinoma, or adenosquamous type) - Your cancer has come back, spread, or not responded to prior treatment - Your overall health is good (ECOG 0–1) - You have adequate organ function (blood, liver, kidney tests within range) **You may NOT be eligible if...** - You have active autoimmune disease - You have had prior anti-PD-1/PD-L1 immunotherapy or anlotinib - You are pregnant or breastfeeding - You have uncontrolled high blood pressure or serious heart problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCadonilimab

All Participants will receive cadonilimab of 10mg/kg every three weeks at day 1

DRUGAnlotinib

All Participants will take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break.

DRUGGranulocyte-Macrophage Colony-Stimulating Factor

All Participants will have subcutaneously injection of granulocyte-macrophage colony-stimulating factor from day 1 to day 14, then take a 7 days break.


Locations(1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

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NCT05817214


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