Actively Recruiting
Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer
Led by Zhongnan Hospital · Updated on 2024-04-19
35
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
Sponsors
Z
Zhongnan Hospital
Lead Sponsor
A
Akeso Biopharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by the patient or legal representative
- Female patients aged 18 to 75 years old
- ECOG performance status score of 0 or 1
- Expected survival of at least 6 months
- Diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Able to provide tumor tissue samples archived within 2 years or willing to undergo a biopsy for fresh specimens
- Have at least one measurable lesion according to RECIST 1.1 criteria
- Received only standard first-line systemic treatment in the past with specific conditions regarding immunotherapy and chemotherapy
- Resting blood pressure below 140/90 mmHg or 24-hour average blood pressure below 140/90 mmHg
- Blood counts meeting specific minimum levels without recent transfusions or growth factors
- Liver function within defined limits for ALT, AST, bilirubin, and albumin
- Coagulation parameters within defined limits without anticoagulant or hemostatic therapy
- Kidney function within defined limits including blood urea nitrogen, creatinine, and urinary protein levels
- Negative pregnancy test within 7 days before starting treatment and agreement to use effective contraception during and for 180 days after the study
- Good treatment compliance
You will not qualify if you...
- Unstable systemic diseases including active infections within 4 weeks or recent serious circulatory events within 6 months
- Uncontrolled type 2 diabetes or pulmonary insufficiency with reduced lung function
- History of autoimmune diseases such as lupus, rheumatoid arthritis, or autoimmune liver diseases
- HIV infection or AIDS; active hepatitis B or C infection
- Recent or planned use of live attenuated vaccines during the study period
- Tumor invasion of major blood vessels posing high bleeding risk
- Previous treatment with anlotinib or cadonilimab
- Active tuberculosis infection within the past year
- Diagnosis of other malignant tumors except certain skin cancers or cervical carcinoma in situ within 5 years
- Major surgery within 28 days before randomization
- Recent active venous or arterial blood clots within 6 months
- Previous or planned allogeneic bone marrow or organ transplant
- Significant intestinal conditions requiring surgery or causing obstruction
- Recent symptoms or history of significant bleeding or bleeding disorders
- Current use of thrombolytic or long-term anticoagulant or antiplatelet therapy at specified doses
- Known allergy to study drugs or their components
- Participation in other drug trials within 4 weeks or within 5 half-lives of last drug
- History of substance abuse or severe cognitive impairment
- Other serious illnesses or factors that may affect safety or study data as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
Research Team
S
Shaoxing Sun, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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