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Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer

NCT05817214 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-04-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cadonilimab

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

DRUG

Anlotinib

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

DRUG

Granulocyte-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.

Sponsors & Collaborators

  • Akeso Biopharma Co., Ltd.

    collaborator UNKNOWN

  • Zhongnan Hospital

    lead OTHER

Principal Investigators

  • Hui Qiu, Ph.D. · Wuhan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-16
Primary Completion
2025-11-30
Completion
2027-02-28

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05817214 on ClinicalTrials.gov