Actively Recruiting
A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical Cancer
Led by West China Second University Hospital · Updated on 2024-02-09
50
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
Sponsors
W
West China Second University Hospital
Lead Sponsor
A
Affiliated Hospital of North Sichuan Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of concurrent chemoradiotherapy（CCRT）followed by cadonilimab（AK104) in high risk local advanced cervical cancer. Participants received CCRT，efficacy evaluation of CCRT was no disease progression who maintained with AK104（10.0 mg/kg，Q3W）until drug exposure over 1 years or disease progression or intolerable toxicity.
CONDITIONS
Official Title
A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary agreement to provide written informed consent.
- Female, age 18 to 75 years.
- Predicted survival of at least 3 months.
- Histologically and/or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, FIGO 2018 stage III-IVA.
- Unable to undergo curative surgery and have not previously received systemic therapy, including radiotherapy, chemotherapy, immunotherapy, or biological therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- At least one evaluable lesion according to RECIST 1.1 criteria.
- Adequate organ function confirmed by laboratory tests within 7 days prior to study treatment.
- Willingness to use contraception as per study protocol.
- Willingness to adhere to the study visit schedule and protocol restrictions.
You will not qualify if you...
- Prior antitumor therapy before concurrent chemoradiotherapy.
- Disease progression during therapeutic evaluation of concurrent chemoradiotherapy.
- Previous treatment with immune checkpoint inhibitors, immune checkpoint agonists, or immune cell therapy.
- Presence of brain metastases.
- Previous allogeneic stem cell or organ transplantation.
- Current or past congenital or acquired immunodeficiency diseases.
- Known or suspected allergies to similar drugs or components of the study drug.
- Positive tests for hepatitis B, hepatitis C, or HIV.
- Receipt of live virus vaccine within 4 weeks before starting trial treatment.
- Serious cardiovascular events within 6 months prior to enrollment.
- Cerebrovascular accident within 6 months prior to enrollment.
- Active infection requiring systemic treatment.
- Uncontrolled hypertension, diabetes, lung diseases such as interstitial lung disease or pneumonia.
- Use of systemic glucocorticoids or immunosuppressive agents within 14 days prior to trial entry.
- History of other malignancies within the last 5 years, except certain treated carcinomas.
- Any condition or abnormality that might interfere with trial participation or results.
- Pregnancy or lactation.
- Assessed as unable or unwilling to comply with protocol requirements.
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Second University Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
R
Rutie Yin, Clinical Professor
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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