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Trial Title:
A Study of Concurrent Chemoradiotherapy Followed by Cadonilimab（AK104） for Newly Diagnosed Local Advanced Cervical Cancer
NCT ID:
NCT06251388
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AK104
Description:
AK104（10.0 mg/kg，intravenous (IV) infusion，Q3W）maintained with no more than 1 year.
Arm group label:
treatment group
Other name:
Cadonilimab Injection
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntary agreement to provide written informed consent.
- female, Age 18 -75 years.
- Predicted survival ≥ 3 month.
- Histologically and/or cytologically confirmed Squamous cell carcinoma,
adenocarcinoma, adenosquamous cell carcinoma, FIGO 2018 stage III-IVA.
- Unable to undergo curative surgery，Pior not received systemic therapy before CCRT,
Including but not limited to radiotherapy, chemotherapy, immunotherapy, and
biological therapy,etc.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Have at least one evaluable lesion (RECIST 1.1 criteria)
- Adequate organ function, evidenced by the following laboratory results within 7 days
prior to the study treatment.
- participants are eligible to participate if they agree to the contraception use as
per study protocol.
- Willing to adhere to the study visit schedule and the prohibitions and restrictions
specified in this protocol.
Exclusion Criteria:
- Has received other antitumor therapy before CCRT.
- Therapeutic evaluation of CCRT was disease progression.
- Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies,
anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists
(such as ICOS, CD40, CD137, GITR, and Ox40 . etc.), immune cell therapy. etc. Any
tumor immune mechanisms treatment .
- With brain metastases.
- Previously received allogeneic stem cell or parenchymal organ transplantation.
- Previously or currently suffering from congenital or acquired immunodeficiency
diseases.
- known or suspected to have a history of allergies to similar drugs, or has a history
of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or is
allergic to excipients of the study drug.
- Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive,
or HIVAb positive.
- Has received a live virus vaccine within 4 weeks of planned start of trial
treatment.
- Within the 6 months prior to enrollment, has serious cardiovascular events such as
pulmonary embolism, acute myocardial infarction, congestive heart failure (New York
Heart Association grade III or IV), and ≥ 2 grade ventricular arrhythmias.
- Cerebrovascular accident within 6 months prior to enrollment.
- Active infection requiring systemic treatment.
- Uncontrolled hypertension, diabetes, Interstitial lung Disease, non infectious
pneumonia , pulmonary fibrosis, acute lung disease, etc.
- Required systemic treatment with glucocorticoid (>10 mg/day of prednisone or
equivalent glucocorticoid) or other immunosuppressive agents within 14 days prior to
enter the trial.
- History of other malignancy within the previous 5 years, except for appropriately
treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers
with a similar curative outcome as those mentioned above.
- Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
subject's participation for the full duration of the trial, or is not in the best
interest of the subject to participate, in the opinion of the treating investigator.
- Pregnancy or lactation.
- Assessed by the investigator to be unable or unwilling to comply with the
requirements of the protocol.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Second University Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Rutie Yin, Clinical Professor
Email:
yrtt2013@163.com
Investigator:
Last name:
Rutie Yin, Clinical Professor
Email:
Principal Investigator
Start date:
February 20, 2024
Completion date:
October 1, 2026
Lead sponsor:
Agency:
West China Second University Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of North Sichuan Medical College
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital Of Southwest Medical University
Agency class:
Other
Source:
West China Second University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06251388
